Prostatic Ultrasound and Needle Biopsy

Prostate cancer is now the most common malignancy in men, both in the United States and in Europe. Approximately 97% of all prostate cancers are adenocarcinoma. Other histologic types include neuroendocrine tumors, sarcoma, carcinoid tumors, melanoma, and metastases to the prostate. Both the morbidity and mortality from prostate cancer are increasing. Whether this is a true finding or just a result of a longer life expectancy and improved technology for early diagnosis is still debated.

DIAGNOSIS

Until the development of transrectal ultrasound (TRUS) of the prostate and of detection methods for prostate-specific antigen (PSA), the digital rectal examination (DRE) was the primary tool in the clinical diagnosis of prostate cancer. Likewise, the histologic diagnosis, indispensable for further management of the disease, has evolved from “blind” finger-guided punctures with a Tru-Cut needle to a procedure of refined echo-guided tissue sampling. The almost simultaneous introduction of a spring-driven “biopsy gun” (Biopty) was an invaluable adjunct to this technique.

INDICATIONS FOR SURGERY

Obtaining a histologic diagnosis of prostate cancer should be the goal whenever this opens therapeutic prospects for patients, but only then. In other words, the suspicion of prostatic malignancy in a man with a limited life expectancy for any reason other then prostate cancer should not automatically lead to any prostatic biopsy procedure. Assuming a reasonable life expectancy, however, the indications for TRUS are either an elevated PSA (actual or age adjusted) or abnormal DRE with any level of PSA. Transrectal ultrasound-guided biopsy is also appropriate in an older man with a limited life expectancy who has obstructive or irritative voiding symptoms. Such a patient may benefit from palliative treatment of a prostate cancer. In addition to securing the diagnosis, TRUS can be used to assist in the collection of directed biopsies from selected areas in and around the prostate, which will assist in staging the disease.

ALTERNATIVE THERAPY

Among the available and generally accepted methods to collect prostate tissue for histologic diagnosis, the transrectal ultrasound-guided biopsy with the “biopsy gun” has become the most popular one over the last years. Blind, digitally guided prostatic biopsies can be done with the same biopsy gun, but they are less accurate, especially for the diagnosis of small, nonpalpable lesions. Transperineal echo-guided biopsies are too laborious and thus reserved for patients in whom the rectal access is impossible. In selected patients the diagnosis is made, sometimes unexpectedly, on histologic examination of tissue material obtained after transurethral prostatic resection.

SURGICAL TECHNIQUE

Although transrectal ultrasound-guided biopsy of the prostate is an outpatient procedure, some precautionary measures and preparations are recommended in order to optimize its accuracy and to minimize complications.

Precautions

Whenever a urinary tract infection might be present, a urinary sample for cytobacteriologic examination should be collected, and eventual infections should be treated adequately. Patients with acquired or iatrogenic coagulation disorders should be, when judged reasonable, medically accommodated with styptics or by temporarily interrupting their anticoagulation treatment. Though infrequently necessary, it is occasionally appropriate to provide some tranquilizing or analgesic drug to very anxious patients.

Preparations

Preoperative cleansing enemas the evening before and the morning of the procedure empty the rectal ampulla of gas and feces, optimizing the visualization. Antibiotic prophylaxis is given empirically, generally a fluoroquinolone the morning of the procedure, followed by a full dose of the fluoroquinolone for 3 days.

Biopsy Technique

The patient is placed on a comfortable examination table, in left lateral decubitus position, knees flexed toward the chest. The examiner takes his or her place on a stool on the right side of the patient and explores the rectal ampulla and the posterior aspect of the prostate with an index finger. The gloved and lubricated finger palpates for gross abnormalities and prepares the patient’s anus for the introduction of the ultrasound probe.

The ultrasound equipment should generate high-frequency (7 to 10 MHz) multiplane images of the prostate. If the probe works with an external needle guide, the guide should be fixed to the probe before its introduction. Internal needle guides can be added with the probe in position. Some probes have an optional small balloon on top, to be filled with water, for better visualization. Even though this balloon will probably be pierced by the biopsy needle, its use is recommended for optimal initial examination of the prostate and seminal vesicles. A condom, filled with some jelly inside, is pulled over the distal part of the probe. After lubrication of the top of this condom, the probe is ready for introduction.

Depending on the other clinical findings (DRE, PSA, previous TRUS), the prostate is first scrutinized for abnormalities. Taking into account possible rebiopsies in case of a negative result, it is good policy to note the DRE and TRUS findings at this time. Especially of interest are the volume of the prostate, the presence of hypoechoic lesions, asymmetries, and discontinuities of the prostate boundary echo. When the biopsies return with a positive result, these data will certainly be helpful in the further management of the disease.

An 18-gauge Tru-Cut biopsy needle is placed in the mechanical actuating device (Biopty or alternative system). Before this device is introduced through the hollow needle guide, the ultrarapid discharge of the gun is checked to ensure the functioning of the system and to accustom the patient to this surprising sound.

The targets in the prostate are now localized by moving the probe in the rectum and switching between the axial and sagittal planes. A little trick to prevent downsliding of the needle along the capsule of the prostate at the time of the biopsy itself is to turn the oblique face of the top of the needle away from the patient.

If the only goal is to know whether an ultrasonically hypoechoic lesion is malignant or not, two or three directed tissue samples of this lesion should be enough. The lesion is brought into view in the sagittal plane, meaning that it is crossed by the electronic puncture line, and the needle is advanced in the guide until its hyperechoic tip is clearly seen at the edge of the lesion.

A gentle warning is addressed to the patient, and the needle is fired off into the lesion. One can easily judge the accuracy of the biopsy, as it is done in real time, and the moving needle creates a very strong reflection along its biopsy course. Even after an apparently perfectly directed biopsy, it is always recommended to take at least one extra core. In a patient who might be a candidate for curative treatment, it is also necessary to collect at least three tissue cores from the contralateral side (see sextant biopsies).

If an indurated prostatic nodule is palpated but not recognized on TRUS, geographic biopsies are indicated. The site of the suspicious lesion, i.e., left or right side, apex to base, is noted, and the biopsies are guided in that region of the prostate. Three additional biopsies from the contralateral side are again the standard.

In patients with suspicion of prostate cancer (elevated PSA) but without palpable or echogenic abnormalities, we recommend the performance of “sextant biopsies”. These biopsies are directed to the lateral margins of the peripheral zone of the prostate, where the majority of cancers originate. On each side three biopsies are taken: one at the apex, one at the base, and one in between. Here, the puncture needle should be advanced until its tip lies just in front of the prostatic capsule. That way one is sure to obtain representative tissue cores of 15 mm. If the “sextant biopsies” return negative from the pathology department and cancer suspicion persists, one can either repeat the procedure or extend it into the transectional zone of the prostate. We do not perform these biopsies routinely as they are far more invasive and painful.

OUTCOMES

Complications

In most cases the postbiopsy period is free of complications, but the patient is always told of possible adverse events. There might be some rectal bleeding, which is usually taken care of with a clean absorbing cloth. Exceptionally an internal rolled lubricated bandage is placed and can be safely removed at home after a couple of hours. Hematuria resulting from a urethral injury can occur, even several days after the procedure. Hemospermia, a benign and predictable event after a prostate biopsy, can frighten the patient, even weeks later.

The patient is always warned of the possibility of high fever or chills and is asked to seek immediate medical help in this event. Again, this is an exceptional complication, certainly after antibiotic prophylaxis.

Results

In Cooner’s 1990 study of the role of transrectal ultrasound, his overall detection rate was 14% for all patients undergoing biopsy. He performed a biopsy only on those patients with a visible hypoechoic lesion. The detection rate increased with increasing PSA: 4.5% of patients with a PSA < 4.0 ng/ml had a hypoechoic lesion with a positive biopsy; 17% of patients with a PSA > 4.0 ng/ml but < 10.0 ng/ml had a positive biopsy; 53% of patients with a PSA > 10 ng/ml had a positive biopsy. Cooner’s detection rate for transrectal ultrasound-guided biopsy in patients with a PSA > 4.0 ng/ml was 33%. Vallancien reported a detection rate of 26% with systematic sextant biopsies in men with a PSA > 4.0 ng/ml and a normal DRE.6 Smith reported a detection rate of 29% at the initial evaluation of men with PSA > 4.0 ng/ml and an overall detection rate of 45% when these same men were followed longitudinally and evaluated with repeat biopsies.

Advertisements

Brachytherapy for Localized Prostate Cancer

Brachy”(therapy), meaning “short” in Greek, describes treatment with radioactive sources or materials placed into, or at a short distance from, the tissue to be radiated. Brachytherapy stands in contrast to “tele”(therapy), Greek for “long,” which refers to external radiation delivered at a distance from the patient and the tumor. Although early attempts at delivering this form of spatially controlled radiation to the prostate date back to the early part of the century, significant clinical investigation of this treatment method did not get under way until the 1960s. At that time, Carlton and co-workers began using radioactive gold combined with external beam irradiation, and Whitmore and associates implanted radioactive iodine. Both procedures consisted of retropubic exposure, bilateral pelvic lymph node dissection, and free-hand insertion of the implant needles for placement of the seeds.

Initially, this innovative treatment for prostate cancer excited interest. A highly confined radiation dose was delivered to the prostate, sparing adjacent, uninvolved tissue. The complication rates, notably incontinence and impotence, were lower than those reported after surgery and external beam therapy of the time period. The free-hand placement technique, however, all too often resulted in poor radiation dose distributions and unsatisfactory local control rates6,7. Additionally, in an era of digital tumor detection, the local failure rates were further escalated by implanting bulky prostates at advanced stages of disease. The unfavorable local control rate, coupled with ongoing improvements in competing treatment modalities, soon led to dwindling interest in prostate brachytherapy.

Significant new developments occurred in the 1980s that served to remedy the shortcomings of the open implant method and rekindle interest in the procedure. These improvements included high-tech imaging and computer software that permitted precise measurement of prostate volume and shape and optimal dose determination. Further, transperineal insertion of the implant needles under real-time transrectal ultrasound monitoring allowed for accurate and reproducible seed placement and more uniform source distribution1. Using low-energy, short-range radioisotopes that favored protection of the adjacent uninvolved tissue permitted delivery of higher radiation doses than could safely be administered by external beam techniques and had the potential for improving local control.

Today, modern prostate brachytherapy can be performed on a cost-effective outpatient basis. It does not require a surgical incision, early results are encouraging, morbidity is minimal, and the patient can usually resume his normal activities in a day or two after treatment.

Dictated by isotope selection, transperineal prostate seed implantation can be divided into temporary and permanent implants. Temporary implants, always combined with external beam irradiation, utilize high-energy sources, such as iridium-192, that are left in the patient for a specific time period and removed. Permanent implants, on the other hand, are left in the patient to decay to an inert state over a specific time period. Although a few centers continue to use gold-198 for implantation, the majority of present-day permanent implants use iodine-125 and palladium-103, both low-energy, short-range sources. This chapter is limited to permanent implantation with these two radionuclides.

Information available to patients to help evaluate and select a treatment program for prostate cancer has significantly increased over the last several years. Prostate brachytherapy, therefore, incorporating up-to-date dosimetry and seed placement technology, should provide the urologist with a timely and practical treatment alternative for patients who either are medically unfit for surgery or do not wish to have it.

Essential to successful application of brachytherapy techniques are proper planning, technical expertise, and meticulous execution. As practiced today, it is a team effort requiring urologic surgical skills, radiotherapeutic planning expertise, and medical physics. The combined efforts and continuous participation of these specialties are important for the success of the procedure. The technique is a three-step process: preimplant planning, operative implant, and postimplant quality evaluation.

INDICATIONS FOR SURGERY

Indications for brachytherapy are any patient with localized adenocarcinoma of the prostate who otherwise has a life expectancy greater than 5 years.

ALTERNATIVE THERAPY

Alternatives to brachytherapy include observation, hormonal deprivation, external beam radiation (teletherapy), and radical prostatectomy.

SURGICAL TECHNIQUE

Preimplant Planning

The main purpose of implant planning is to assure a systematic approach to the individual patient. The custom-tailored plan permits delivery of a high dose of radiation to the prostate with maximal sparing of juxtaposed healthy tissue. The “preplan” has several components.

Patient Selection

With the effective radiation encompassing only a 5-mm margin beyond the prostate, patients selected for interstitial radiation with iodine-125 and palladium-103 as monotherapy should have a high probability of organ-confined disease. No generally accepted and applied criteria for the selection of organ-confined lesions exist. However, increasing data indicate that the combination of clinical stage, number and locations of positive biopsies, presenting PSA level, and biopsy Gleason pattern scores are helpful in singling out patients with the highest probability of having lesions confined to the prostate, i.e., having all the prostate cancer included in the effective radiation field. For patients suspected of having periprostatic extension of the disease, an implant alone is not adequate therapy. The addition of external beam irradiation to a dose of 45 Gy may be indicated in order to sterilize periprostatic tumor extension.

Comorbidity status as it relates to anesthetic risks must be evaluated, though restrictions for a 45-minute bloodless seed implantation need not be as stringent as for surgery.

Additionally, it is important to identify risk factors that may give rise to urinary and rectal complications after implantation. Significant urinary obstructive symptoms, for example, may lead to urinary retention because of swelling from the radiation. If the lateral lobes are the cause of obstruction, a 3-month course of total androgen ablation before implantation will usually rectify the condition. Median bar obstruction, in our experience, responds poorly to hormonal manipulation and is best corrected before the implant with a transurethral incision of the prostate (TUIP). A previous transurethral prostate resection (TURP), performed even years before, carries increased risk for stress incontinence. In such patients, differential loading of the sources away from the prostatic urethra may help prevent this complication.

Selecting large glands for implantation carries two types of risks. First, the bony pubic arch may overlay the anterolateral part of the prostate and prevent transperineal needle insertion. Second, large glands require more seeds. Consequently, there is an increase in total dose, which may adversely affect adjacent tissue, such as the rectum and bladder. For these reasons, current knowledge dictates caution in implanting glands over 50 cc. The majority of large glands may be reduced to acceptable volumes by total androgen ablation for 3 months before brachytherapy.

Prostate Volume Specification

An accurate prostate volume description with delineation of adjacent rectum, urethra, and bladder is fundamental to precise source positioning and conformal dosimetry. Although volume determination and treatment planning can be performed using computed tomography, most centers prefer to use transrectal ultrasound step-sectional planimetry. Advantages include its low cost, excellent cross-sectional anatomy, and high correlation with real-time monitoring during the actual implant. The circumference of 5-mm spaced transverse prostate images from apex to base of the gland, overlaid with a template configuration corresponding to the template needle puncture channels, are demarcated with a lightpen. Computer software calculates the volume.

Prostate–Pubic Arch Relationship

Pubic arch interference, where the pubic rami may prevent the transperineal insertion of implant needles, most commonly occurs in glands over 50 cc but may also be encountered with smaller glands. It is important to recognize this condition in the planning stage rather than in the operating room. A simple method of detecting pubic arch obstruction entails the superimposition of the ultrasound image of the pubic arch over the widest transverse image of the prostate. In the face of pubic arch obstruction, shrinkage of the gland through total androgen blockade for 2 to 3 months may be necessary to make an implant possible.

Seed-Loading Method Selection

Once the prostate volume and its spatial geometry have been determined, the seed-loading pattern is selected. The Quimby pattern is characterized by a uniform source distribution across the target volume. The Patterson–Parker motif uses a peripherally weighted source allocation, implanting 60% to 70% of the total activity into the periphery of the gland. The Quimby method results in a radiation distribution that is characterized by a high central dose at the midpoint of the prostate and by a larger number of lower-strength seeds. Implants by this method are technically easier because small seed movements are less apt to result in underdosage or overdosage.

The high central dose may have the further advantage of greater tumor destruction but must be applied with caution in patients who have had a prior transurethral resection and consequent damage to the urethral blood supply. In these patients, the peripherally weighted Patterson–Parker method, with its lower central dose and lower likelihood of urethral damage, may be preferable. However, peripheral loading represents a more difficult implant and demands greater precision in source placement for a homogeneous dose distribution. It has the further disadvantage of delivering lower central doses to the tumor and involves a higher risk of rectal injury because high-activity seeds are placed close to the rectum.

Target Volume Specification

The target volume differs from the prostate volume in that it encompasses a 2- to 5-mm margin beyond the prostate periphery on the 5-mm-spaced transverse images, with slightly more generous margins at the apex, base, and biopsy-positive tumor sites.

Isotope Selection (Iodine-125/Palladium-103)

The two sources are both low-energy emitters. Both are physically similar, enclosed in miniaturized biocompatible titanium cylinders. With their low tissue penetration ability, they pose little or no hazard to medical personnel. The isotopes differ primarily in their half-lives and, therefore, in the rate at which they deliver radiation. Iodine-125, with a half-life of 60 days, emits energy at 8 to 10 cGy per hour, whereas palladium-103, with a half-life of 17 days, delivers at a rate of 20 to 24 cGy per hour. With lower dose rates, recovery of sublethally damaged cells may, at least conceptually, lessen the ultimate tumoricidal effect of the radiation. Some investigators therefore prefer to use the higher-dose-rate palladium-103 when treating poorly differentiated tumors. Because of the increased biological effect of the higher dose rate of palladium-103, some reduction in the total target dose is necessary.

Conformal, Computer-Based Dosimetry

Most institutions performing brachytherapy use the matched peripheral dose (MPD) convention developed at the Memorial Sloan-Kettering Cancer Center to describe the dose of radiation delivered to the tumor over the entire period of decay for the radioisotope used. The aim here is to deliver a dose to the prostate margins approximating that achieved with external beam therapy, which has been determined to be 160 Gy for iodine and 115 Gy for palladium. When brachytherapy is combined with a preliminary course of 45 Gy of external beam supplement, the iodine dose is lowered to 120 Gy, and palladium to 90 Gy. The spatial seed configuration is determined by entering each of the serial target volume images into a dosimetry computer to determine source spacing and strength for optimum dose homogeneity and distribution that will deliver the prescribed MPD to the periphery of the prostate while limiting radiation to adjacent structures. Isodose curves are then calculated for each transverse ultrasound image to determine if the proposed dose adequately covers the entire gland. If not, the seed location, number of seeds, or seed strength is adjusted to assure optimal coverage.

The Implant Worksheet

The computer-derived isodose plan with digitized target volume contours and resultant seed configuration is tabulated onto a worksheet. This reference facilitates needle loading and guides the urologist and radiation oncologist during the operative implant.

Operative Implant

The implant, as described by Holm and associates in 1983, consists of implanting 18-gauge needles preloaded with seeds and spacers. The treatment plan designates specific template coordinates and prostate location. In order to ensure accurate placement of the needles within the prostate, needles are guided to their specific designations in the prostate by transrectal ultrasound.

The procedure is done under spinal anesthesia with the patient in the dorsal lithotomy position and the urethra injected with an ultrasound enhancement agent (emulsion of air and K-Y jelly) for visualization. The scrotum is displaced toward the abdominal wall with a plastic/adhesive drape, and the perineum is prepped. Brackets fastened to the operating table support a stepping unit to hold a biplanar, multifrequency endorectal transducer (Bruel & Kjaer model 8551, Marlborough, MA) that is attached to an ultrasound system (Bruel & Kjaer model 3535). A multichannel needle-steering device, which corresponds to the electronic grid matrix superimposed on the transverse ultrasound prostate images of the volume specification, is attached to the rectal probe.

The probe with the transducer is inserted into the rectum. While scanning through the gland with the template coordinate grid activated, the probe is adjusted until the sequential images on the TV monitor correlate with the planning scan images. At that time the support brackets are locked in position. The prostate is very mobile and may need to be stabilized before needle insertion. The implantation begins anteriorly and proceeds posteriorly to prevent target shadowing of seeds already placed. Each needle is guided to its preplanned position in the gland under direct transverse and/or sagittal ultrasound observation.

Real-time monitoring of the needle insertion process is of critical importance. Even though the prostate has been stabilized, needle insertion may distort and move the gland. Any deviation and internal distortion should be recognized and adjusted for. When a needle is correctly positioned, the obturator is held stationary by an assistant, and the needle is withdrawn. In this way, rows of alternating seeds and spacers are deposited into the preplanned positions in the gland.

The position of the base and prostatorectal interface are monitored throughout the procedure. The operator must regularly observe the transverse and sagittal images. The ultrasound transducer is adjusted in 5-mm increments in the caudal direction for those template coordinates that do not call for seeds at the most cephalad portion (base) of the gland. At the completion of the needle insertion, an AP fluoroscopy is performed to assess the uniformity of seed distribution. Extra seeds may be implanted wherever there appears to be a spatial deficiency. Also, fluoroscopy will portray stray seeds in the bladder, which may be removed cystoscopically and reinserted.

Postimplant Evaluation and Management

Evaluation of implant quality is performed on every patient using three-dimensional CT-based calculations. The evaluation consists of dose computation and dose analysis for target and surrounding structures based on the actual implant. Five-millimeter slice thicknesses are scanned using soft-tissue-density images for prostate volume and bone density windows for seed delineation. Isodose curves are generated for each CT image, yielding a detailed analysis of radiation distribution relative to the CT-determined target volume.

Patients are routinely examined at 3-month intervals for the first 2 years, every 6 months for the next 3 years, and yearly thereafter. All follow-up visits consist of clinical evaluation and serum PSA measurement. Four-quadrant TRUS-guided postimplant needle biopsies are recommended for all patients. Treatment results are determined based on clinical freedom from disease, freedom from biochemical (PSA) failure, and repeat biopsy results. There is now increasing evidence that, of these, the PSA assay is the most sensitive index of tumor biological activity. Unlike surgery, where the presence of PSA activity after removal of the prostate is a reliable indicator of treatment failure, irradiated prostate epithelial cells continue to secrete measurable amounts of the antigen, albeit in small quantities. What the exact level should be is as yet uncertain, but several investigators believe the posttreatment level should decrease and remain at 1.0 ng/ml or less to validate biological cure.

OUTCOMES

Complications

Early Complications

Adverse effects up to 12 months after the implant include obstructive and irritative symptoms. They occur to some extent in most patients, with the severity of symptoms often related to the degree to which such symptoms were experienced before treatment. The symptoms subside over a few weeks to a few months. Should obstructive symptoms persist, it is best to manage the patient by intermittent catheterization for at least three half-lives of the isotope—6 months for iodine and 2 months for palladium—before intervening surgically. A prostate incision at the 6-o’clock position (TUIP) is often all that is required. Transurethral resection is associated with an increased risk of incontinence in patients who received a uniform-distribution (Quimby) implant and is best avoided. Peripherally weighted (Patterson–Parker) implants minimize the urethral dose and do not appear, at least in a short-term follow-up study, to be associated with any increase in complications in patients with transurethral resections.

Late Complications

In one series, 320 patients were implanted by the uniform source distribution method (Quimby) and followed for 7 years. Two of the 320 (0.6%) required urinary diversion for severe urethral stricture and incontinence, and another 25 (8%) required minor office procedures such as cystoscopy, urethral dilation, and sigmoidoscopy. Erectile dysfunction did not present itself in patients below 60 years of age but occurred in 20% of patients between the ages of 60 and 70 years. Another series reported on 71 patients implanted with the peripherally weighted (Patterson–Parker) implant technique and followed for a mean of only 2 years. Investigators noted only mild radiation proctitis in 4.2% and urinary retention in 5.6%. During this time period, only 6% of the patients experienced erectile difficulties.

Results

Three hundred twenty T1/T2 patients were treated with iodine-125 or palladium-103 as monotherapy at Northwest Hospital between January 1987 and June 1993. Median presenting PSA was 6.7 ng/ml (range 0.2 to 74.6), and the Gleason pattern scores at diagnosis, available in 313 patients, were: 2 to 4 (130), 5 and 6 (161), and 7 to 10 (22). Median follow-up was 50 months (range 24 to 97 months). No patients were pathologically staged, and none was treated with hormones.

The 7-year actuarial local control rate was 97%, the distal disease-free control rate 95%, and the PSA progression-free status 83%. In patients with no clinical/pathologic evidence of prostate cancer, PSA progression is defined as two consecutive increases in serum PSA from a minimum inflection (nadir) regardless of absolute PSA levels. In this series of patients, PSA progression—however minimal—preceded all local and distal clinical failures.

Posttreatment biopsy was obtained in 192 of 320 (60%). Biopsy results and corresponding PSA levels are: negative, 83% (median PSA 0.3); indeterminate, 13% (median PSA 0.6); positive, 4% (median PSA 3.0). Biopsy specimens were interpreted as indeterminate based on the presence of residual neoplastic cells exhibiting severe radiation effect. The viability of such cells is uncertain; however, experience with this pathologic category suggests that the majority of these biopsies convert to negative with time.

A subset of 112 patients in this cohort has been followed for a minimum of 5 years. The PSA progression-free rate (non-Kaplan–Meier) is 105 of 112 (94%); the PSA £ 1.0 ng/ml rate is 101 of 112 (90%); and the PSA £ 0.5 ng/ml rate is 95 of 112 (85%). Eighteen patients agreed to repeat needle biopsy 5 years or more beyond treatment, three of whom were biopsied because of PSA progression. Negative biopsy was found in 16 of 18 (89%), one patient (5.5%) was graded indeterminate, and one patient (5.5%) failed locally with a positive biopsy.

These results are encouraging, but randomized trials to support the therapeutic advantages of prostate brachytherapy are lacking. Thus, the definitive curative potential of brachytherapy must await longer-term follow-up. Brachytherapy does, however, offer some distinct advantages over the common treatment modalities. It is a one-time, low-morbidity, and cost-effective outpatient procedure that is less socially disruptive than either surgery or external beam treatment.

The utilization of transrectal ultrasound and template guidance systems has greatly improved radioisotope implantation of the prostate. These improvements allow for high radiation doses to be safely delivered to the target tissue in an accurate and reproducible manner. The curative results with brachytherapy, at least at intermediate durations of follow-up, are comparable to those achieved with radical surgery and external beam irradiation. Current success and the prospects for further improvement argue that, at least for the immediate future, incorporating brachytherapy in the treatment armamentarium will allow the urologist to play a wider role in providing care for patients with localized prostate cancer.

Radical Perineal Prostatectomy

Radical perineal prostatectomy, first performed in 1869 by Buchler and popularized in the United States by Young in 1905, remained the primary surgical approach to carcinoma of the prostate until the mid-1970s. With the recognition of the importance of assessing pelvic lymph nodes preoperatively and the advantage that retropubic prostatectomy offered with concomitant pelvic node dissection, perineal prostatectomy declined in popularity for the treatment of prostate cancer. The perineal approach, however, has seen a resurgence in the 1990s for several reasons: (a) the trend toward minimally invasive surgery with a focus on reducing the morbidity and therefore the hospital stay of patients, (b) the advent of laparoscopic surgery for lymph node assessment, (c) the introduction of PSA for screening for prostate cancer with reduction in the numbers of patients with node-positive disease, and (d) algorithms that may predict patients at high risk for positive lymph nodes. The procedure is also associated with reduced blood loss, low morbidity, and can be modified to incorporate the neurovascular sparing techniques for preservation of potency.

DIAGNOSIS

All patients who are potential candidates for radical perineal prostatectomy should undergo preoperative staging to assure that the patients are operable candidates. Methods of differentiating local from advanced disease include digital rectal examination, transrectal ultrasonography, radionuclide bone scan, assessment of pelvic lymph nodes, as well as pathologic indicators of progression such as Gleason sum and other markers.

Since the late 1980s, PSA has made a significant impact on the preoperative stage of patients with prostate cancer. Patients presenting for surgery are generally younger, healthier, and more likely to have organ- confined prostate cancer than the population treated only a decade earlier, and this in many ways contributes to the large increase in the number of radical prostatectomies done in the United States in the past decade. Other contributing factors are the modifications in technique that have reduced morbidity, including the nerve-sparing technique described by Walsh and alternative methods of restoring potency.

Digital rectal examination has a limited role in the clinical staging of prostate cancer. Its primary capability is to crudely estimate the volume of the cancer. Transrectal ultrasonography is another modality that also has limitations in assessing local disease but, combined with digital rectal examination, at least gives some gross assessment of likelihood of extracapsular disease. Other modalities such as transrectal MRI, CT scan, and pelvic MRI have been shown to have limited usefulness. Radionuclide bone scans are useful in assessing advanced bony disease but generally are not positive in patients with PSA below 20 ng/ml and no other sign of advanced disease.

For the past 11 years we have prospectively applied an algorithm to the preoperative assessment of patients with prostate cancer based on the evaluation of over 400 patients who had undergone pelvic node dissection at our institution. The current algorithm includes patients with a Gleason 7 or less, with low-volume cancer (T1b–c, T2a), normal acid phosphatase, and PSA of less than 20. Patients meeting all of these criteria have a less than 5% chance of positive lymph nodes, and, therefore, we do not perform pelvic lymph node dissections. Patients exceeding any one of the above criteria are considered to be in the high-risk group and have undergone pelvic lymph node dissections.4 With this method of assessment, our PSA recurrence rate from 1988 through 1994 was 27%, which compares favorably to our own and other series of retropubic prostatectomies, which have shown PSA recurrence rates between 24% and 29%.4,7,9 Because 75% of the patients who did not develop PSA recurrences had PSA <10 ng/ml, we have now modified our algorithm to place patients in the low-risk group if the serum PSA is <10 ng/ml.

INDICATIONS FOR SURGERY

Patients who are candidates for radical prostatectomy must have clinically organ-confined prostate cancer (T1–2). In addition to having organ-confined disease, other factors that need to be taken into consideration are the patient’s life expectancy, other comorbidities, or any other factors that may affect the patient’s choice. We generally would not offer a radical prostatectomy to patients who have a life expectancy less than 10 years. Over the age of 70, we would offer a radical prostatectomy only in selected cases in which we feel that the benefits that can be obtained from radical prostatectomy outweigh the potential risks, particularly when compared to alternative therapies.

ALTERNATIVE THERAPY

Alternatives to radical prostatectomy include observation, hormonal deprivation, and radiation therapy. We do not consider either observation or hormonal deprivation to be curative, and the patients for whom this is a good option are those patients with less than 5 years of life expectancy, patients who are over 70 years old with a well-differentiated cancer, or patients who are a high risk for surgery and refuse radiation. Overall, observation is associated with a 75% mortality over 10 years. Radiation therapy, however, may be definitive and has an equivalent 5- and 10-year survival. The recurrence rates with radiation therapy are bimodal, with initial recurrences within 1 to 2 years of treatment and a delayed peak at 5 to 7 years after treatment. In our institution, 359 patients who received brachytherapy from 1972 to 1984 were compared to a contemporaneous series of 161 patients undergoing radical prostatectomy. The 5-year recurrence rates and survival were similar in both groups, which were equivalent in preoperative stage, age, Gleason sum, and other demographics. By 7 years, however, the recurrence rate among the brachytherapy group was 48% (9% local recurrence, 39% distant recurrence) versus 27% in the radical prostatectomy patients (8% local and 19% distant recurrence). If the patient is young and has a 15-year or longer outlook, we feel that our results would favor radical prostatectomy.

SURGICAL TECHNIQUE

Before the patient is put in position, the legs are wrapped with Ace bandages. The patient is placed in an exaggerated lithotomy position. It is important that the patient’s perineum be parallel to the floor in that this directly affects exposure. We use a standard operating room table with folded sheets under the patient’s sacrum supporting the patient’s entire weight. We do not use shoulder braces, and if a patient tends to slide off the sheets, we will place the table in a slight reverse Trendelenburg position. The patient’s legs are stabilized using candy cane stirrups, again taking precautions to prevent stretching the hamstring or causing pressure on the legs.

Four instruments are significant in assisting the surgeon for this operation. These include the Lowsley curved tractor, the Young straight prostatic tractor, a halogen headlamp, and an Omnitract miniwishbone retractor system. The curved Lowsley tractor is used to bring the prostate up into the perineum to allow the dissection against the prostate while separating the rectum from the prostate. The straight Young tractor is used to manipulate the prostate laterally as well as cephalad and caudad after the membranous urethra has been divided. The halogen headlamp is important in that it allows the surgeon to aim a strong light into the operative field, which may be deep and narrow, preventing standard operating lights from adequately illuminating the structures. The Omnitract miniwishbone allows virtually unlimited retraction in any direction.

It should be noted that, in manipulation of the prostate from the perineum, the pelvis should be viewed as a cone with its apex at the site of the incision. To get better visualization at times, it may be necessary to actually push the prostate further into the pelvis. Also note that traction is not placed directly on the bulb or membranous urethra, as this will decrease the likelihood of restoration of potency and potentially affect the patient’s continence postoperatively.

The incision is made from the ischial tuberosity, crossing the midline at the juncture between the squamous epithelium and mucocutaneous border of the rectum. The incision extends posteriorly to a line equal to the posterior portion of the anus. By use of sharp dissection and electrocautery, the ischiorectal fossae are entered, and the central perineal tendon is identified by blunt dissection and transected with an electrocautery. At this point, we employ the Belt approach and dissect down to the white fascia of the rectum and proceed subsphincterically. Predominantly by blunt dissection with an index finger in the rectum, the rectal sphincter and levator ani can be dissected free of the rectum with minimal bleeding, and the blades from the miniwishbone retractor are then used to retract these muscles anteriorly and laterally. With tension on these muscles and tension on the rectum, the rectourethralis is identified and divided, which allows the surgeon to dissect the rectum free of the apex of the prostate.

If this is to be a nerve-sparing technique, the dissection is carried down to approximately 1.5 to 2 cm from the apex, at which point the posterior layer of Denonvillier’s fascia is divided, and dissection is carried between the two layers of the Denonvillier’s fascia. Care is taken not to damage the neurovascular bundles that course along the lateral posterior prostate on either side.

The distal portion of Denonvillier’s fascia is then incised in the midline with scissors, and the tag is then used to facilitate dissection of the neurovascular bundle from the prostate; the inferior pedicle, if present, is ligated and divided. If the dissection is in any way impaired by fibrosis such that there is a potential for prostatic tissue to be left behind, the neurovascular bundle is sacrificed on that side. It should be noted during this dissection that the neurovascular bundle actually courses across the posterior surface of the prostate at the apex and enters the urogenital diaphragm just posterior to the membranous urethra. This proximal relationship is important in that the vesicourethral anastomosis may incorporate the neurovascular bundle if the sutures are placed too deeply during the anastomosis. Once the neurovascular bundle has been dissected, a Vessi-loop is placed around this to aid in lateral traction.

The retraction of the neurovascular bundle on either side thereby exposes the proximal membranous urethra, allowing a right-angled clamp to be placed around the membranous urethra. There should be little resistance anterior to the urethra to the passage of the tip of the right-angled clamp anterior to the urethra if one stays posterior to the endopelvic fascia. The Lowsley tractor is removed, and the membranous urethra is divided. The Young tractor is then placed into the bladder via the severed prostatic urethra, and the endopelvic fascia is dissected free of the anterior prostate. In most cases, there is insignificant bleeding from the dorsal venous complex, but if there should be communicating veins, they should be ligated using 3-0 Vicryl.

The groove between the prostate and bladder is identified, and, with either sharp or blunt dissection, the prostate and bladder can be separated. If there is any resistance to blunt dissection, the bladder neck should be sharply divided, and biopsies taken of the bladder neck to assure that the resistance is not secondary to bladder neck invasion with the cancer. Patients who have had prior transurethral resections may have an obliteration of the plane between the prostate and bladder, and the blades of the Young tractor can be used to aid in this identification.

The prostate is dissected from the bladder anteriorly to the 5-o’clock and 7-o’clock positions, respectively, on the patient’s left and right; the bladder neck is divided over the Young tractor, and the Young tractor is removed. The bladder is evacuated of any urine, and the posterior bladder neck is divided at its juncture with the prostatic urethra. The prostate is then dissected free from the posterior bladder, allowing identification of the superior pedicles of the prostate as well as the seminal structures. The superior pedicles are isolated, divided, and ligated. The seminal vesicles are dissected to their tips with blunt dissection, and the artery from the seminal vesicle is either cauterized or ligated; the vasa deferentia are generally cauterized. Finally, the Denonvillier’s fascia overlying the seminal structures is divided, allowing removal of the prostate.

After complete hemostasis has been ensured, the bladder neck is reconstructed using 3-0 Vicryl on an SH needle, beginning posteriorly to anteriorly as described by Dees. This direction of the closure, beginning in the posterior bladder, is done to facilitate the closure without injury to the ureters and also to take advantage of the anatomic relationship between the bladder neck and the membranous urethra with the shorter distance being anteriorly. The anastomosis is performed using 3-0 Vicryl simple sutures and an RB-1 controlled-release needle around a 22-Fr 5-cc Foley catheter. Generally, seven or eight interrupted sutures are used for this anastomosis, though, alternatively, the anastomosis can be performed with a running suture. Care should be taken that small portions of the membranous urethra are incorporated in the anastomosis so that the continence mechanism is left undisturbed and the neurovascular bundles that contribute to potency are avoided.

The rectum is then inspected; a Foley balloon is inflated, and a Penrose drain is placed through the left ischiorectal fossa and a separate stab incision. The incision is closed with a 3-0 chromic gut closure. One suture is placed to reapproximate the central tendon, and the remainder of the sutures are used to close the skin in a horizontal mattress.

Postoperatively, the patients have very low requirement for pain medication. Most patients either do not require parenteral pain medication or are off the parenteral medications within 12 to 24 hours. Average time to discharge is approximately 48 hours from the time of surgery. The patient’s catheter is removed on the 12th day. The Penrose drain is removed before discharge.

OUTCOMES

Complications

Perioperative complications include hemorrhage, wound infection, cardiovascular complications, and rectal injury. The incidence of rectal injury is less than 2%, and with current techniques, preoperative bowel preparation (Golightly), and antibiotics, these are closed primarily in two layers without the need to perform a diverting colostomy. Wound infection rates are less than 1%, and cardiovascular complications are approximately 1%. The average blood loss in these patients is approximately 450 cc, and our transfusion rate is less than 5%.

Long-term complications include incontinence and impotence. Incontinence requiring intervention such as pads, clamps, or inflatable devices occurs in 2.8% of our patients. We have found that incontinence generally occurs in patients who are older, obese, or have had prior radiation therapy. Potency following nerve-sparing perineal prostatectomy is dependent on the patient’s age and preoperative status. Patients under the age of 60 who are fully potent and have both neurovascular bundles spared have approximately a 50% potency rate. Patients who are over the age of 60 have a reduced rate of potency, and we have not yet had a patient over the age of 70 who has spontaneously regained his potency. Patients who are having difficulties with potency before surgery and patients in whom the neurovascular bundles could not be spared will likely be impotent. We generally advocate early use of pharmacologic or other means of assistance in these patients to help them regain their potency.

Results

Following radical prostatectomy, recurrence can be measured using PSA, which is exquisitely sensitive. Any patient who undergoes a radical prostatectomy can expect his PSA to fall below detectable levels. Its failure to do so generally means that the patient has significant residual disease, either locally or distantly. Another group of patients will have an initial drop in their PSA to undetectable levels and then a return to measurable levels. These patients may have local and/or distant recurrence of their disease or possibly residual malignancy. Patients who develop recurrence based on PSA will generally manifest a clinical progression within 18 months. Additionally, if the PSA is going to rise, it will do so within 2 years in 90% of patients and within 4 years in virtually every patient. Based upon surrogate markers such as PSA, we can now predict disease recurrence earlier, allowing assessment of the outcome of radical prostatectomy within 5 years as opposed to the older data, which required a 7- to 10-year follow-up.

The primary predictor of recurrent disease after radical prostatectomy is the presence of positive margins. In SEER data, radical prostatectomy has been shown to have a long-term disease-free rate approaching 90% at 10 years with organ-confined disease. Positive margins may reflect capsular penetration, invasion of the periprostatic tissue, or may reflect a pathologic discrepancy. Patients with negative margins will have a 10% risk of recurrence, and the risk of recurrence with positive margins will be 30% to 50%. Before PSA screening, the incidence of positive margins in patients undergoing radical prostatectomy in our institution was 48% with an overall PSA recurrence rate of 24%. Whether the current reports of 20% positive margin rates with serial PSA screenings has a proportional drop in the PSA recurrence rates remains to be seen.

Radical Retropubic Prostatectomy

The unprecedented increase in the incidence of carcinoma of the prostate that has occurred over the last decade has resulted in a corresponding increase in the rate with which radical prostatectomy is performed. Refinements in patient selection and surgical technique have diminished the morbidity of surgery. Nonetheless, many patients maintain concern about the risks and potential side effects of the operation. Knowledge of surgical anatomy and attention to operative technique can help diminish both the side effects and the overall expense of treatment.

DIAGNOSIS

Clinically localized carcinoma of the prostate is diagnosed most frequently in asymptomatic men who present for early detection or screening programs or during the course of a routine physical examination. Digital rectal examination and serum prostate-specific antigen (PSA) are accepted modalities for prostate cancer detection. Almost 20% of clinically diagnosed cancers are detected by digital rectal examination in the face of a normal serum PSA level. On the other hand, stage T1c cancers, i.e., those detected on a biopsy prompted by an abnormal PSA level in the face of a normal digital rectal examination, constitute the most common category of cancers diagnosed in most clinical series.

Tumor grade is one of the most important prognostic criteria, though in more recent studies, preoperative PSA may also be predictive. Computerized tomography scanning of the pelvis to identify lymph node metastasis is usually not indicated. A radioisotope bone scan is usually performed if the serum PSA level is greater than 20 ng/dl but rarely is positive for metastasis if the PSA is below that level.

INDICATIONS FOR SURGERY

Radical prostatectomy is indicated in patients with carcinoma of the prostate seemingly confined within the surgical capsule of the gland, who would be expected to have a life expectancy of at least 10 years. Thus, appropriate patient selection requires accurate tumor staging as well as an assessment of patient comorbidity.

Despite its well-recognized limitations, digital rectal examination (DRE) remains the standard method for assessing tumor extent within the prostate, though DRE often understages palpable tumors. Large, palpable tumors frequently are found to have histologic evidence of extracapsular extension. Transrectal ultrasonography (TRUS) is the most commonly used imaging modality for prostate cancer. Typically, carcinoma of the prostate is identifiable as a hypoechoic area in the peripheral zone of the prostate. However, prospective studies have not shown the superiority of TRUS compared with DRE for staging the local extent of prostate cancer. The serum PSA level is useful in identifying patients with localized disease. In general, a serum PSA level >20 ng/ml is highly suspicious for extracapsular extension.

Radical prostatectomy usually is not indicated in patients who otherwise have a life expectancy less than 10 years. Although clinical carcinoma of the prostate is a progressive disease, the rate of tumor growth is such that competing causes of death dominate in elderly patients or those with poor overall health. Both chronologic as well as physiological age must be taken into account. Life table analysis indicates that most men less than 70 years of age with good overall health can anticipate at least 10 years of additional life.

ALTERNATIVE THERAPY

The term “watchful waiting” has been applied to a nonaggressive treatment approach that consists primarily of intermittent monitoring of disease status with institution of delayed hormonal therapy on evidence of symptomatic disease progression. This is probably the preferred approach in most men with less than 10 years of life expectancy. External beam irradiation is an alternative treatment for clinically localized prostate cancer. Five- and ten-year survival figures are comparable to those obtained with radical prostatectomy, but good comparative figures beyond that time range are not available. Concerns frequently are expressed about a high rate of positive biopsies after radiation therapy and the failure of the treatment to suppress serum PSA levels to the undetectable range. Interstitial brachytherapy using radioactive seeds was abandoned in most centers during the early to mid-1980s because of inferior results. More recent series use a perineal template with ultrasound guidance for seed implantation, but there are insufficient patient numbers and follow-up to draw conclusions about the merits of this approach. Cryotherapy is being explored as a treatment approach, but only short-term results are available.

Once radical prostatectomy is chosen, either a retropubic or perineal approach is most often used. The advantages of a retropubic approach are the opportunity to simultaneously inspect or sample pelvic lymph nodes, the potential for wide excision of periprostatic tissues, and a very low risk of rectal injury.

SURGICAL TECHNIQUE

Radical retropubic prostatectomy is performed at our medical center with the patient in a supine position and the table slightly flexed. We prefer a general anesthetic and have not observed any advantage for the use of epidural catheters. Invasive anesthetic monitoring such as central venous catheters or arterial lines are not used. A 20-Fr Foley catheter is inserted in the bladder after the field has been prepped and draped sterilely.

A midline incision is made from the umbilicus to the pubis. The anterior rectus fascia is incised, and then the rectus muscles are retracted laterally. Blunt and sharp dissection are used to mobilize the peritoneal envelope superiorly. Blunt finger dissection can help create a pocket directly over the psoas muscle and just lateral to the common iliac artery, which facilitates superior retraction of the peritoneum. The vas deferens is retracted along with the peritoneum. Care should be taken to make certain that the epigastric vessels are not injured beneath the belly of the rectus muscle during this maneuver.

We use a Bookwalter self-retaining retractor. An oval ring is used, and bladder blades retract the skin and rectus muscle at the inferior and lateral aspect of the incision. Deeper retractors at this point can result in femoral neuropathy or compression of the iliac vein. At the superior and lateral portion of the incision, a malleable blade is used to retract the peritoneum.

Placement of the retractors in this manner provides excellent exposure of the operative field. Pelvic lymph node dissection, is performed if the serum PSA level is greater than 20 ng/ml or the Gleason sum of the tumor grade is 7 or greater. Otherwise, the iliac and obturator lymph nodes simply are inspected for any evidence of enlargement or induration.

A sponge stick is used to displace the prostate and bladder medially. A Kittner dissector is used to remove some of the loose fat overlying the endopelvic fascia and to expose the junction between the lateral prostate and the levator ani muscle. Electrocautery is used to incise the endopelvic fascia overlying this space. A Kittner dissector then separates the levator muscle from the lateral margin of the prostate. If the incision is made too close to the prostate, bleeding from the overlying venous plexus can occur on the lateral margin of the prostate. Under these circumstances, it is best to place a suture of 3-0 Vicryl along the lateral prostate in order to gain hemostasis.

After the endopelvic fascia has been incised bilaterally, a sponge stick is used to depress the bladder posteriorly. The fatty tissue overlying the anterior prostate is carefully teased away using forceps and the sucker tip. This exposes the superficial dorsal vein. We prefer to control this vein separately from the deep dorsal vein complex. If the superficial dorsal vein is small, it can simply be cauterized and then divided. A larger vein is ligated with 3-0 Vicryl. Care must be taken in applying the ligature to the distal end of the vein, as it is quite friable and can be avulsed from the underside of the pubis.

After the superficial dorsal vein is divided, a Kittner dissector is used to define the puboprostatic ligaments. These usually are evident as a distinct white ligamentous structure. Often, there is some adherent levator muscular tissue just lateral to the puboprostatic ligament, and this sometimes contains a small vein. A right-angle clamp passed just lateral to the puboprostatic ligament can define this tissue well and allow it to be dissected from the lateral prostatic apex using electrocautery.

It is important to define the puboprostatic ligaments precisely, as described above. This allows them to be divided with Metzenbaum scissors with little risk of bleeding. Also, this minimizes injury to the anterior sphincter mechanism. After the puboprostatic ligaments are divided, the anterior portion of the prostatic apex falls away partially from the pubic bone.

The deep dorsal vein complex runs parallel to the urethra at the prostatic apex and then fans out over the anterior of the prostate. We feel that it is important to control these vessels preemptively rather than simply to incise them and place sutures afterward. A McDougal clamp is useful for this purpose. The dorsal vein complex can be pinched partially off from the anterior urethra with the thumb and forefinger of the left hand, and the jaws of the McDougal clamp passed just anterior to the urethra. Bleeding is rare during this maneuver if the anatomic structures are carefully dissected and defined. Spreading the jaws of the clamp should be avoided so as not to injure the anterior sphincter mechanism. A #1 Vicryl ligature is then tied around the dorsal vein complex. The McDougal clamp is then passed through the same space again and held in position while a 2-0 Vicryl suture on an SH needle is passed through the center of the dorsal vein complex just distal to the previous ligature. After the anterior portion of this stick suture is tied, the McDougal clamp is used to pull the end of the suture around the posterior aspect of the dorsal vein complex, which is then controlled further by tying the two suture ends. Back bleeding is prevented by placing a 0 Vicryl suture on a CT 1 needle through the veins of the dorsal vein complex, where they fan out over the anterior prostate. Grasping the lateral margins of the veins with an Allis clamp helps to bunch them in the middle and facilitates placement of this hemostatic suture. The McDougal clamp is once again passed through the previously defined space. Electrocautery is then used to divide the dorsal vein complex just proximal to the 0 Vicryl ligature placed earlier. Sometimes this ligature becomes displaced during this process, but the backup 2-0 Vicryl fixed suture maintains hemostasis. As the electrocautery is used, the McDougal clamp is gently lifted to displace the electrical energy away from the sphincter muscle. This entire technique usually allows total hemostasis during division of the dorsal vein complex, and no additional hemostatic sutures generally are required.

At this point, the anterior sphincter muscle should be untouched and the prostatic apex and membranous urethra visible. Metzenbaum scissors are then used to incise directly over the anterior portion of the membranous urethra just at the prostatic apex. The Foley catheter is identified and withdrawn through the partially severed urethra after the injection port and connector end have been cut off. The Foley catheter is not used for traction, as this can injure the urinary sphincter complex or cavernous nerve. The posterior portion of the urethra is divided under direct vision using Metzenbaum scissors.

The sequence of the next maneuver depends on whether or not a nerve-sparing approach for potency preservation is to be used. If nerve sparing is attempted, a right-angle clamp is used to lift the thin reflection of the endopelvic fascia onto the lateral margin of the prostate. This is incised with a knife up to the level of the prostatic pedicle. A Kittner dissector is then used to displace this fascial leaf posterolaterally. This carries with it the blood vessels and nerves that can be displaced from the lateral margin of the prostate. Small bleeding vessels that may be encountered during this maneuver are usually left alone at this point to avoid injury to the neurovascular complex. After the neurovascular bundle has been satisfactorily displaced from the prostate, the layer of fascia and muscle tissue commonly termed the rectourethralis muscle is incised sharply. Excellent hemostasis is necessary in order to perform this maneuver under direct vision, which is highly preferable. Blunt finger dissection can then be used to develop the plane between the prostate and rectum, but it is important not to pull hard on the prostate. The remaining posterior attachment of the prostatic apex is divided sharply with Metzenbaum scissors immediately adjacent to the prostate.

If a nerve-sparing approach is not used, the incision in the rectourethralis muscle is performed without dissecting the neurovascular bundle from the lateral prostate. The plane between the prostate and rectum is developed bluntly, and then the neurovascular bundle is excised widely at the prostatic apex by ligating it with 2-0 Vicryl sutures before incising it as widely as possible from the prostatic apex. However, even if a non-nerve-sparing approach is used, care should be taken to avoid excessive traction on the prostate, which could tear sphincter muscle tissue.

At this point, the table is placed in partial Trendelenberg position to allow better visualization of the posterior prostate, the seminal vesicles, and the prostatic pedicle. An incision is made through the posterior layer of Denonvillier’s fascia with electrocautery. This exposes the seminal vesicles and ampulla of the vas deferens. A right-angle clamp can then be placed just lateral to the seminal vesicle and around virtually the entire prostatic vascular pedicle. Care should be taken to avoid going too far cephalad with the right-angle clamp, as this can cause bleeding in some of the veins in the perivesical fat. A 2-0 Vicryl suture is used to ligate the prostatic pedicle. Because it is difficult to place two ties far enough apart to allow an incision between them, we usually simply use electrocautery to incise the tissue on the prostate side of a single tie. Small back bleeders from the prostate can then be controlled individually with the electrocautery.

Complete division of the prostatic pedicle greatly facilitates visualization and dissection of the seminal vesicles. A right-angle clamp is passed around the ampulla of the vas deferens just medial to the seminal vesicle. The ampulla is divided with the electrocautery, and the proximal end of the vas deferens is clamped with the right angle. This can then be used for traction in dissecting the medial edge of the seminal vesicle with the electrocautery. A right-angle clamp is then passed around the seminal vesicle and used to help dissect the surrounding tissue down to the tip of the seminal vesicle. The artery to the seminal vesicle enters at the tip and usually can be coagulated with an electrocautery after it is individually identified. We prefer not to use clips at any point in the procedure, as these have been known to migrate through the urethrovesical anastomosis.

After both seminal vesicles have been divided, they are lifted superiorly to expose the junction between the posterior prostate and the bladder neck. This is developed partially with electrocautery, and any remaining lateral attachments are also taken down with electrocautery. This should provide good definition of the bladder neck so that the electrocautery can then be used to incise anteriorly. If the bladder neck is well defined, identification of the ureteral orifices is not necessary before the removal of the surgical specimen is completed by dividing the remainder of the bladder neck attachments. However, if there is a question of tumor encroachment toward the bladder neck, a wider margin should be taken. Under these circumstances, it is best to visualize the bladder trigone before incising the posterior bladder neck. In rare circumstances, 5-Fr pediatric feeding tubes are passed up the ureteral orifices to facilitate their identification and preservation during the dissection.

After the surgical specimen is removed, careful hemostasis is obtained. If a potency-sparing approach is used, small bleeding vessels along the neurovascular bundle are left alone. Larger bleeding vessels near the bundle are controlled with a 4-0 chromic suture. Otherwise, virtually all other vessels are controlled with electrocautery. In order to identify bleeding vessels in the pelvis, any bleeding from around the genitourinary diaphragm is compressed with a sponge held in place with a small Deaver retractor. Often, if an anatomic dissection has been performed, bladder neck reconstruction is not required. Otherwise, 2-0 Vicryl sutures are placed in a posterior-to-anterior manner to close the bladder neck to the point where it just admits the tip of an index finger.

We have found a grooved urethral sound most useful for placement of the urethral anastomotic sutures. External perineal compression has been unnecessary, as the urethral stump generally is readily visible, and suture placement is not difficult. The operating surgeon uses the left hand to manipulate the urethral sound and the right hand to place the anastomotic sutures. We use five sutures spaced proportionately around the urethral circumference. The sutures on the patient’s left side are most easily placed outside to in and incorporate only the urethra. We use 2-0 Vicryl for the anastomosis and have a double-armed needle that allows inside-out placement of the sutures on the patient’s right. The sutures are then placed in a corresponding position in the bladder neck. We do not place mucosal eversion sutures before forming the anastomosis, but an Allis clamp placed anteriorly on the bladder neck can nicely evert the mucosa. A 20-Fr Foley catheter with a 5-cc balloon is passed through the anastomosis before placement of the most anterior sutures to prevent any tangling of the sutures that could result in catheter entrapment. The same style of clamps are always used to tag these sutures and avoid any confusion. For example, straight hemostats are used for the two most posterior sutures, curved hemostats for the two paired anterolateral sutures, and a Kocher clamp for the most anterior suture.

The Foley catheter balloon is inflated with 8 cc of water, and the table flexion is released. A sponge stick is used to displace the bladder medially so that the anastomotic sutures can be tied. After all of the sutures have been tied, the anastomosis is inspected both visually and manually to make certain that all of the ties have gone down completely and that there is no portion of the catheter either visible or palpable. Rarely, the anastomosis is not felt to be completely secure. Under these circumstances, we take down the anastomosis and redo it. Although this is painstaking, a secure anastomosis can help avoid long-term complications after the procedure.

We place a single Jackson–Pratt drain directly over the anastomosis and bring it out through a stab wound just lateral to the incision. The incision is closed with a running 1 Vicryl suture, and the skin is closed with a subcuticular 4-0 Vicryl suture.

OUTCOMES

Complications

When the aforementioned technique is used, intraoperative bleeding complications are unusual. Our median blood loss is less than 500 cc. We do not ask patients to donate autologous blood preoperatively, as our transfusion rate is less than 2%. Excessive drainage is extremely uncommon, and the Jackson–Pratt drain is removed on the second or third postoperative day.

Thromboembolic problems remain the most frequent cause of serious morbidity and occasional mortality after radical retropubic prostatectomy. Clinically recognized deep venous thrombosis occurs in 3% to 5%, and pulmonary embolus in 1% to 3% of patients. Routine use of anticoagulants in the perioperative period diminishes the rate of thromboembolic complications but does introduce a risk of wound or operative site bleeding or hematoma. We use heparin prophylaxis in patients at a high risk for thromboembolism such as those with obesity or a history of deep venous thrombosis.

The most concerning long-term complications of radical prostatectomy are the possibilities of impotence or incontinence. The risk of impotence is directly related to patient age, potency status before surgery, and whether a nerve-sparing approach is used unilaterally or bilaterally. Over half of younger men undergoing a bilateral nerve-sparing approach can anticipate the return of erections suitable for intercourse postoperatively. Incontinence requiring further treatment occurs in around 2% of patients, but up to 15% to 20% of patients have at least occasional episodes of stress incontinence.

Results

We have designed and implemented a collaborative care pathway for patients undergoing radical retropubic prostatectomy. The target date for hospital discharge is the second or third postoperative day. Ninety-four percent of our patients have accomplished this goal with no apparent adverse effect on morbidity. This is, however, but one factor in overall hospital charges. Operating room charges constitute the major component of overall costs in patients undergoing radical retropubic prostatectomy. By addressing all aspects of perioperative care, we have diminished hospital charges and costs by over 40% through a collaborative care pathway.

After surgical removal of the entire prostate, the serum prostate-specific antigen level should be undetectable. The success with which this occurs depends on pathologic tumor stage. If the tumor is completely confined within the prostatic capsule and of low to intermediate grade, nearly 90% of patients have an undetectable PSA, which apparently translates into long-term cure. As with any surgical procedure, the success of radical retropubic prostatectomy depends on appropriate patient selection and careful attention to anatomic detail and surgical technique.

Pelvic Lymphadenectomy

The pelvic lymph nodes are the initial site of spread of prostatic, bladder, and proximal urethral malignancies. Tumors of the penis, scrotum, and distal urethra spread primarily to the inguinal lymph nodes but can involve the pelvic lymph nodes. Testicular tumors rarely involve the pelvic lymph nodes unless there is massive retroperitoneal disease or a history of orchidopexy or prior pelvic procedures. Most urologists perform pelvic lymph node dissections in patients with prostate or bladder cancer.

DIAGNOSIS

Pelvic lymphadenectomy is performed as a staging procedure in patients with prostate or bladder cancer.

INDICATIONS FOR SURGERY

Presence of lymph node metastases from prostate cancer has prognostic significance and is a harbinger of disease progression.1 In a series from Memorial Sloan-Kettering Cancer Center, 86% of patients with pelvic lymph node metastases measuring over 3 cc had disease progression within 5 years. Pelvic lymph node dissection has not been shown to be of therapeutic benefit in the treatment of prostate cancer.4 However, there are patients who have small-volume nodal disease and prolonged survival after lymphadenectomy and radical prostatectomy. It is unclear whether this prolonged survival is a consequence of tumor biology, the treatment, or a combination of the two.

P>Pelvic lymph node dissection may be performed as a staging procedure before definitive radiation therapy, as a separate procedure for prostate cancer, i.e., before a radical perineal prostatectomy, or concomitant with a radical retropubic prostatectomy.

Serum PSA screening has led to a stage migration in newly diagnosed cases of prostate cancer and to a lower incidence of pelvic lymph node positivity. The incidence of unsuspected pelvic lymph node disease found at exploration has decreased. In the past, nearly 25% of patients with clinically localized prostate cancer were found to have lymph node metastases at the time of surgery.10 A review of the last 140 pelvic lymph node dissections performed at the University of California–Davis, for clinically localized prostate cancer revealed four cases of lymph node involvement.

We perform pelvic lymph node dissections concomitantly with a retropubic prostatectomy but feel that, with the lower incidence of nodal disease, performing them as a separate procedure, i.e., laparoscopically, is not cost-effective. For patients undergoing a perineal prostatectomy, there are a small number who would benefit from a lymphadenectomy. For patients being treated with radiation therapy, we no longer perform a lymph node dissection.

For bladder cancer, there is more agreement in favor of the benefits of pelvic lymphadenectomy. A series from Memorial Sloan-Kettering Cancer Center demonstrated that the 5-year survival rate for patients with pelvic lymph node metastases was 9%.3 This would suggest that the pelvic lymph node dissection is mainly of prognostic rather than therapeutic value. However, Skinner reported a 35% 3-year survival rate for patients who were found to have a limited number of positive lymph nodes at the time of surgery, suggesting that the node dissection may have therapeutic benefits. The presence of positive lymph nodes in bladder cancer patients has implications for treatment options. Some urologists would treat with chemotherapy and reevaluate the bladder rather than proceeding with the radical cystectomy, but others favor debulking the tumor with cystectomy followed by postoperative chemotherapy. If we find grossly enlarged lymph nodes with histologic evidence for metastatic disease, we follow the former course of therapy. However, if the lymph nodes are grossly normal, we proceed with the radical cystectomy without sending the lymph nodes for frozen section evaluation. A national study is under way assessing the value of neoadjuvant chemotherapy. If it reveals an advantage for preoperative chemotherapy, the finding of nodal disease at the time of surgery becomes more challenging. Some urologists might argue that, in this situation, surgery would be the only chance for the patient, but others would argue that, neoadjuvant chemotherapy having failed, surgery would have little role in the management of these patients.

ALTERNATIVE THERAPY

Noninvasive methods of detecting pelvic lymph node spread have not been reliable. Various radiologic tests, i.e., ultrasound, computerized tomography, magnetic resonance imaging, and pedal lymphangiography, have been used to detect pelvic lymph node disease, but these have had low sensitivity. As a marker for prostate cancer, the use of serum prostate acid phosphatase (PAP) has low sensitivity and specificity. In addition, the use of serum prostate-specific antigen (PSA) alone is not a good predictor of pathologic stage, as there can be significant overlap between the PSA and the pathologic stage. Pelvic lymph node dissection is the definitive means of evaluating lymph node status in patients undergoing extirpative procedures for urologic malignancy.

With the arrival of minimally invasive techniques, laparoscopic lymphadenectomy has been performed. Another modification is to perform the dissection through a minilaparotomy incision when it is done as a separate procedure. In comparing the efficacy, morbidity, and cost effectiveness of a minilaparotomy pelvic lymph node dissection to those of a laparoscopic or standard open pelvic lymphadenectomy, the minilaparotomy approach had a similar lymph node yield to the standard open procedure and a similar shortened hospital course to the laparoscopic dissection, but at a lower cost compared to the other two.8

Much has recently been written questioning the need for pelvic lymph node dissection before definitive treatment for prostate cancer. On preoperative evaluation, there may be patients with a low likelihood of lymph node disease who do not need a lymphadenectomy. This may not eliminate lymphadenectomies completely, but it could decrease the number performed. A similar change occurred with PSA values and bone scans for prostate cancer staging. Narayan et al. found an 11% overall incidence of positive pelvic lymph nodes.6 In patients with PSA values less than or equal to 10 and Gleason grades less than or equal to 6, fewer than 3% had lymph node metastases. They felt that, in this group of patients, a staging pelvic lymphadenectomy would not be necessary. Campbell et al. reported a lymph node positive rate of 6.5% in patients with clinically localized prostate cancer, whereas if at least one favorable characteristic (Gleason grade less than 6, PSA less than 10, or nonpalpable tumor) was present, only 2.2% had lymph node involvement. Patients with a low probability of lymph node involvement, i.e., low Gleason grade and low PSA, might not require a pelvic lymph node dissection, which adds both cost and time to the definitive treatment. However, this is still somewhat controversial.

DESCRIPTION OF PROCEDURE

Prostate Cancer

The boundaries of the traditional pelvic lymph node dissection were those used in combination with radical cystectomies for bladder malignancies. They included the pelvic sidewall laterally, the paravesical fascia and peritoneum medially, the genitofemoral nerve superiorly, the obturator nerve inferiorly, and the femoral canal distally. Proximally, the dissection was carried varying distances up the common iliac artery. Most urologists now feel that only the obturator nodal packet need be removed for three reasons:

First, the obturator nodes are involved in 87% of cases when lymphatic metastases are found.

Second, the procedure is for staging and not therapy, so a more extensive dissection is of little benefit.

Third, if radiation therapy is used for local control following surgery, patients who had an extensive lymphadenectomy have a higher incidence of scrotal or lower limb edema.

Preoperatively, pneumatic compression devices (PCDs) are placed, and patients are given subcutaneous heparin as prophylaxis against deep venous thrombosis. Supine or lithotomy position may be used, although we use the low lithotomy position. The sacrum is positioned over the table break or a roll to allow for hyperextension of and better vision into the pelvis. The bladder is emptied using a Foley catheter. A midline incision is made from below the umbilicus to the symphysis pubis down through the anterior rectus sheath. The posterior rectus sheath is incised for 2 to 3 cm above the linea semilunaris to aid in lateral retraction of the wound. An extraperitoneal lymph node dissection is usually performed. If the peritoneum is entered during this incision, the defect is closed with absorbable suture.

The transversalis fascia is sharply divided in the midline to allow lateral dissection superficial to the peritoneum. This helps to avoid injuring the inferior epigastric vessels. The iliac vessels are exposed by bluntly sweeping the peritoneum superomedially. The vas deferens are encountered during this maneuver and may be divided. The table is tilted toward the first side for evaluation. If the prostate cancer is confined to one lobe, the dissection is begun on that side. A self-retaining retractor is applied, with care taken not to injure the inferior epigastric vessels. We use the Buchwalter retractor without the post, as it can be more quickly applied and the post can interfere with the surgeon. Other self-retaining refractors may be used.

We place the Buchwalter retractor on top of sterile towels, one on each thigh and one on the abdomen. A bladder blade and moist lap sponge are used to retract the wound laterally on the side of the dissection. A malleable retractor and moist lap are placed on the bladder and used to retract the bladder toward the contralateral side. A third retractor is placed at the apex of the wound. With these three retractors, excellent visibility can be obtained.

The nodal packet is palpated to detect grossly enlarged lymph nodes. If such nodes are found, they are sent for frozen section evaluation following removal. If no enlarged nodes are palpated, we continue with the lymphadenectomy and prostatectomy and do not send the lymph nodes for frozen section.

The external iliac artery is identified, and dissection of the lymph node packet is begun over its anteromedial aspect. The correct plane of dissection is easily found here, and there are no other structures in this area to be damaged. The dissection is brought proximally to the bifurcation of the common iliac vessels and distally to the femoral canal. The lymph node of Cloquet is the most distal aspect of the dissection. Lymphatic channels into this node and surrounding the external iliac vein are carefully clipped and divided. We place a right-angle clamp around the lymph node packet and ligate it with a 2-0 silk tie. A large right-angle clip is placed below the tie. As the nodal packet is divided and swept superiorly, an accessory obturator vein may be found and should be ligated and divided to avoid avulsion. Identification of this vein is necessary, as damage can cause extensive bleeding.

With gentle lateral retraction of the external iliac vein, the lymph node packet is dissected off the pelvic sidewall laterally. Although a vein retractor is usually used for this maneuver, we use a peanut/Kittner dissector. Identification of the obturator nerve is essential as the dissection is carried into the pelvic fossa to avoid injuring it. The packet is freed from the obturator nerve and vessels. The obturator vessels are spared if they are in their usual location below the nerve. If they are above the nerve or involved with the lymph node packet, it is best to ligate and divide them before bleeding can occur. This is especially true near the femoral canal. The superior attachment of the packet is now near the internal iliac artery. We previously identified and dissected out the ureter, but, in most cases, we no longer do this. To ensure the ureter is not damaged by a clip, the specimen is split over the obturator nerve, and a right-angle clip is placed over either limb of the split packet on each side of the nerve so that the ureter cannot accidentally be included in the clip. Additional loose attachments to the proximal hypogastric vessels are clipped and divided. The entire packet is sent to pathology as the two portions divided over the obturator nerve. The obturator fossa is irrigated. It had been our routine to leave a gauze sponge in the fossa for hemostasis; however, we now do this only for minimal oozing. The same dissection is then performed on the contralateral side to complete the lymph node dissection. We place one or two Jackson–Pratt drains in the pelvis postoperatively.

Bladder Cancer

The dissection is similar to the one described above for prostate cancer with some differences. The incision is carried to just above the umbilicus and down to the pubic bone. We palpate the pelvic lymph nodes while remaining extraperitoneal. If no grossly enlarged nodes are felt, the dissection becomes intraperitoneal. The peritoneum is entered in midline, and inspection is performed of the intra-abdominal organs for signs of metastatic disease. If none are found, dissection is continued by mobilizing the cecum and ascending colon. The peritoneum is incised along the white line of Toldt, and the right hemicolon is rolled medially. The right ureter is identified and freed superiorly and inferiorly. Inferiorly, this leads to the bifurcation of the iliac vessels. In freeing the peritoneum, we routinely divide the vas deferens. On the left, the peritoneum is incised lateral to the sigmoid colon, and it is reflected medially. The left ureter is identified and freed as on the right. Mobilization is aided by dividing the vas deferens.

The self-retaining retractor may be placed as described above. The bowel can easily be retracted into the upper abdomen, as it has been mobilized. The node dissection begins over either common iliac artery just proximal to the bifurcation. It is carried down the hypogastric artery to the superior vesicle artery, which is identified and divided. The remainder of the lymph node dissection is similar to that for prostate cancer.

OUTCOMES

Complications

Although pelvic lymph node dissection is usually a relatively short procedure with little morbidity, it has a potential for significant complications. These can be divided into intra- and postoperative complications. Paul et al. reported an 8.6% incidence of intraoperative complications, an 8.7% immediate postoperative wound complication incidence, and an additional 31.4% immediate non-wound-related complication rate. They also reviewed the complication rates reported in multiple studies. These ranged from 4% to 53% with a mean rate of 26.6%. Intraoperative complications can be minimized by familiarity with the pelvic anatomy and careful dissection to identify vulnerable structures. The most common vascular injury is to the accessory obturator vein. Care should be taken not to avulse the obturator vessels as they enter the pelvic foramina, as they will retract caudally, and ligation will be difficult. If this occurs, bone wax can be used. Significant injuries to the external iliac vessels require repair, sometimes with the aid of a vascular surgeon. Transection or avulsion of the obturator nerve leads to difficulties with adduction of the ipsilateral leg and is usually irreparable. Splitting the nodal packet as described reduces the chance of inadvertent nerve injury.

Ureteral injuries are uncommon and require repair when encountered. A problem with ureteral injuries is that they are not always identified at the time of surgery. These are often the result of a clip inadvertently being placed across the ureter. Therefore, as we now dissect out the lymph node packet, we no longer specifically look for the ureter. However, we always place a clip on the upper end of the nodal packet after splitting it over the obturator nerve in a cranial-to-caudal direction to avoid injury to the ureter, identified or not. If there is any concern for ureteral injury, the ureter must be dissected out and fully visualized.

Postoperative complications include those related and unrelated to the wound. Wound infections are uncommon, especially when prophylactic antibiotics are given. Dehiscence is similarly uncommon. Seroma and hematoma formation are more common and may require drainage and local wound care.

Prolonged lymph drainage and lymphocele formation may occur in 3% to 12% of patients. Prolonged drainage is treated by instilling autologous blood or Betadine solution through the preexisting drains as sclerosing agents. If Jackson–Pratt or similar drains are used, tissue will eventually grow into the drains. This has occurred twice in our experience, and in both cases a general anesthetic was required for drain removal. We now remove all drains or treat them as described above for prolonged drainage at the end of 2 weeks. Although it has been reported that the use of subcutaneous heparin increases the incidence of prolonged lymph drainage, this has not been our experience. Our rate of prolonged lymph drainage and/or symptomatic lymphocele formation is under 3%. Symptomatic lymphoceles can often be successfully treated with percutaneous drainage under radiologic guidance. Although some lymphatic drainage is expected, careful dissection and meticulous ligation of lymphatic channels help minimize the risk of prolonged drainage.

Any patient with prolonged or excessive lymph drainage must be evaluated for a urinary leak. This may be done by sending a sample of the fluid for creatinine. If a urine leak is found, this may be from either the anastomosis or an unrecognized ureteral injury. If the latter is suspected, it should be immediately investigated.

Thrombophlebitis and deep venous thrombosis are recognized complications of pelvic lymph node dissection. Although the studies are conflicting, most have shown that some method of anticoagulation, low-dose heparin or pneumatic compression stockings, are beneficial in reducing the risk of these complications. We routinely administer subcutaneous heparin preoperatively and every 8 to 12 hours postoperatively as well as use pneumatic compression stockings until the patient is discharged.

Chronic lymphedema of the lower extremities and external genitalia may occur, and these may be worsened by radiotherapy or an extensive dissection. The modified pelvic lymph node dissection has been a reliable way of preventing chronic lymphedema.

Results

Staging pelvic lymphadenectomy is an essential part in the clinical evaluation of patients with prostate and bladder cancer. Within the obturator fossa, 87% of positive nodes will be detected. In patients with low-grade prostate cancer and with a PSA < 10, the incidence of positive nodes is so low that it may become prudent not to perform a pelvic node dissection as a separate procedure. In bladder cancer, the value of a node dissection may be to identify those patients in whom preoperative chemotherapy may be of benefit, though this remains to be shown in a clinical trial.

Open Prostatectomy

Open prostatectomy is the enucleation of the hyperplastic adenomatous growth of the prostate. This procedure does not involve total removal of the prostate. A tissue plane exists between the adenoma and the compressed true prostate, which is left intact. Three surgical approaches to the prostate are described in this chapter: suprapubic, retropubic, and perineal.

DIAGNOSIS

Over 90% of prostatectomies for benign prostatic hyperplasia are performed by transurethral resection of the prostate (TURP). When the obstructing tissue is estimated to weigh more than 50 g, serious consideration should be given to an open procedure. Digital examination, prostatic ultrasound, and cystourethroscopic measurement of the prostatic length may aid in the estimating of the size of the gland. Findings on cystourethroscopy may indicate an open procedure, such as sizable bladder diverticuli, which justify removal, or large bladder calculi, which are not amenable to easy fragmentation. The association of an inguinal hernia with an enlarged prostate may lead to a suprapubic or retropubic procedure because the hernia may be repaired by way of the same lower abdominal incision.

INDICATIONS FOR SURGERY

The indications for prostatectomy include the following symptoms or findings secondary to prostatic obstruction: acute urinary retention; recurrent or persistent urinary tract infections; recurrent gross hematuria; documented significant residual urine after voiding with or without overflow incontinence; pathophysiological changes of the kidneys, ureters, or bladder; abnormally low urinary flow rate; and normal flow rate with abnormally high intravesical voiding pressure and intractable symptoms such as nocturia, frequency, and urgency.

Contraindications to an open prostatectomy include a small, fibrous gland, carcinoma of the prostate, or prior prostatectomy in which most of the prostate has previously been resected or removed and the planes are obliterated.

ALTERNATIVE THERAPY

Alternative therapies to open prostatectomy include transurethral resection of the prostate (TURP), endoscopic procedures including incision of the prostate, laser ablation, vaporization techniques, thermotherapy, and medical management. Most of these therapies are effective for moderate (medical management) to severe symptoms in prostates less than 60 g (alternative surgical techniques) and are therefore not indicated in the majority of patients who are candidates for open prostatectomy. The patient’s bladder outlet symptoms could also be managed alternatively by intermittent catheterization, an indwelling catheter, or a suprapubic cystostomy. None of these are good alternatives if the patient is a reasonable surgical risk.

SURGICAL TECHNIQUE

Preoperative Management

The average age of patients is about 70 years. Many of the patients have histories of cardiovascular disease, chronic obstructive pulmonary disease, diabetes, or hypertension. It is preferable to evaluate the upper urinary tract with either an intravenous pyelogram and a postvoid film if the patient’s renal function is normal or an abdominal radiograph and a renal sonogram. Cystourethroscopic examination should be performed to rule out unexpected bladder pathology. This can be done just before surgery under the same anesthetic. If the patient has a documented urinary tract infection, it should be treated before planned elective surgery and may necessitate indwelling catheter drainage before the procedure.

Transfusion of blood may be required in about 15% of patients undergoing open prostatectomy. It is prudent to have 2 or 3 units of blood available when contemplating the procedure. The safest transfusion is autologous blood, and individual units can be drawn a week apart while the patient is on oral iron medication.

Spinal or epidural anesthesia is preferred in all prostatectomy procedures. If regional anesthesia is contraindicated, a general anesthetic with adequate relaxation may be used.

Informed consent is necessary. The patient must be made aware of the risks and complications. Most patients can be evaluated as an outpatient and then admitted to the hospital on the day of surgery. This is cost effective and reduces hospitalization.

Suprapubic Prostatectomy

Suprapubic prostatectomy or transvesical prostatectomy is the enucleation of the hyperplastic adenomatous growth of the prostate performed through an extraperitoneal incision of the anterior bladder wall.9 Eugene Fuller of New York is credited with performing the first complete suprapubic removal of a prostatic adenoma in 1894. This was a blind procedure with digital enucleation of the gland. Suprapubic and perineal drainage tubes were placed to wash out clots and control bleeding. Peter Freyer of London popularized the operation and subsequently published his results of over 1,600 cases with a mortality rate of just over 5%. The entire operation was usually a 15-minute procedure. A 5- to 8-cm midline suprapubic incision was made, and the bladder was opened without opening the lateral tissue spaces or entering the space of Retzius. Digital enucleation of the prostate was then performed. One or two fingers were placed in the rectum for counterpressure while the suprapubic enucleation was accomplished. The prostatic fossa was left alone because Freyer thought that the capsule and surrounding tissues at the bladder neck would contract down enough to control bleeding somewhat like a parturient uterus immediately after childbirth. He left an indwelling urethral catheter and a large suprapubic tube to evacuate clots. His low mortality and morbidity rates are remarkable considering that no blood transfusions or antibiotics were available at that time. This blind enucleation remained popular for over 50 years. The low transvesical suprapubic prostatectomy with visualization of the bladder neck and prostatic fossa and placement of hemostatic sutures has supplanted the blind procedure.4 This operation is presented in more detail.

The patient is placed in the supine position with the umbilicus positioned over the kidney rest; the table is slightly hyperextended and in a mild Trendelenburg’s position. A catheter is introduced into the urinary bladder; the bladder is irrigated and then filled with 200 to 250 ml of water or saline, and the catheter is then removed. The abdomen and genitalia are prepped from nipple line to midthigh. A vertical midline suprapubic incision is made through the skin and linea alba with the incision extending from below the umbilicus to the symphysis. The rectus muscles are retracted laterally, and the prevesical space is developed, with the peritoneum swept superiorly. It is not necessary or desirable to expose the retropubic or lateral vesical spaces. For more adequate exposure, a self-retaining retractor is used.

Two sutures are placed in the anterior bladder wall below the peritoneal reflection. A vertical cystotomy is then made, and the incision is opened down to within 1 cm of the bladder neck, allowing visualization of the bladder neck and prostate. A medium Deaver retractor is placed into the open bladder, retracting superiorly. A narrow Deaver is then placed over the bladder neck just distal to the trigone. The curved end of the Deaver retractor provides an excellent semilunar line for incising the mucosa around the posterior bladder neck just distal to the trigone. By this method, the ureteral orifices are well visualized and are not compromised. Metzenbaum scissors are introduced at the 6 o’clock position, and, by gentle dissection, the plane between the adenoma, bladder neck, and the capsule of the prostate is developed.

The remainder of the procedure is done by digital dissection, freeing the posterior lobes down to the apex of the prostate and then circumferentially sweeping anteriorly. The urethra is firmly attached at the apex. It is preferable to use scissors to sharply incise the urethra, keeping close to the prostatic adenoma so as not to cause injury to the sphincter and subsequent incontinence. With large glands, it is often preferable to remove one lobe at a time, or, if there is a large intravesical protrusion of the middle lobe, this may be removed separately.

After removal of the adenoma, the prostatic fossa is inspected, and a digital sweep is made to ascertain if there is any remaining nodular adenomatous tissue. There is usually minimal bleeding; however, bleeding is frequently seen in the 5- and 7-o’clock positions. The prostatic arteries enter the capsule and prostate at this level near the bladder neck. Suture ligature of these vessels is done even if there is no active bleeding. Figure-of-eight sutures of 2-0 chromic on a 5/8 circle needle provide good hemostasis.

A 22-Fr, 30-ml balloon, three-way Foley catheter is passed through the urethra. A 26- or 28-Fr Malecot suprapubic tube is passed through a separate stab wound in the anterior bladder wall and brought out through a stab wound in the lower abdominal wall. A watertight, single-layer, interrupted closure of the bladder with either 2-0 chromic catgut or Vicryl is done, just missing the mucosa but including full thickness of the muscularis and serosa. The balloon of the Foley catheter is inflated to 45 ml and placed on no traction. A 4-0 chromic catgut suture is placed as a pursestring around the suprapubic tube; this prevents any leakage and helps to hold the suprapubic tube gently in position during wound closure. A Penrose drain is placed down to the cystotomy site and brought out through a separate stab wound. The bladder is irrigated until clear and checked for significant leakage.

The wound is irrigated, and the linea alba is closed with a running #2 nylon or #1 PDS suture. The skin is approximated with skin staples. The drain and suprapubic tube are sutured to the skin with nylon sutures, and a dressing is applied.

Postoperatively, excessive blood loss is the most common immediate complication encountered; about 15% of patients require a blood transfusion. If excessive bleeding from the prostatic fossa is noted intraoperatively, two techniques are effective in stopping the bleeding. Malament described the placement of a #1 or #2 nylon pursestring suture around the vesical neck; the suture was brought out through the skin and tied snugly. This effectively closes the bladder neck and tamponades the prostatic fossa with control of bleeding. Between 24 and 48 hours after placement, the suture is cut on one side and removed. O’Conor10 described placation of the posterior capsule using 0 chromic catgut on a 5/8 curved needle. This placation narrows the fossa and results in effective hemostasis. Point fulguration of bleeders in the fossa may also provide hemostasis.

Antibiotics are not indicated for elective prostatectomy in patients who have had no urinary tract infections and have sterile urine. If there has been a long-term indwelling catheter or preoperative infection, appropriate perioperative antibiotics, a cephalosporin and an aminoglycoside or a fluoroquinolone, are indicated.

The patient is usually limited to intravenous fluids the day of surgery, but the following day he can usually tolerate oral nutrition, often having a full diet. A stool softener or mild laxative is given to prevent straining with bowel movements or fecal impaction. Continuous bladder irrigation by way of the three-way Foley catheter is maintained for 12 to 24 hours. The Foley catheter usually is removed after 3 days, although one can remove the suprapubic catheter first. If the Foley catheter is removed first, the suprapubic tube is clamped at 5 days to give the patient a trial at voiding. It is removed the following day if voiding is satisfactory with little residual. The drain is removed a few hours after removal of the suprapubic tube if there is no drainage. The skin staples are removed on the seventh postoperative day, and the skin is covered with sterile strips. On discharge from the hospital, the patient is encouraged to increase his activity gradually and should be able to resume full activity 4 to 6 weeks postoperatively, with outpatient visits at 3 and 6 weeks.

Retropubic Prostatectomy

Simple retropubic prostatectomy is the removal of the hyperplastic prostatic adenoma by way of a prostatic capsule incision. Van Stockum is credited with performing the first retropubic prostatectomy, which he called “extravesical suprapubic prostatectomy.” A longitudinal capsular incision was made on one side of the midline. Millin reported his operative technique and results in 1945. His procedure gained wide acceptance, and he is credited with popularizing retropubic prostatectomy. Various modifications have subsequently been described.

The patient is placed in the supine position with the umbilicus positioned over the kidney rest; the table is slightly hyperextended and in a mild Trendelenburg’s position. The lower abdomen and suprapubic area are shaved, and the entire operative field from nipple line to midthigh is scrubbed with surgical solution. A Pfannenstiel incision may be used, but I prefer a vertical midline incision extending from below the umbilicus to the symphysis. The linea alba is opened, and the rectus muscles are retracted laterally.

The prevesical and retropubic space is developed, with the peritoneum and extraperitoneal fat swept superiorly. A self-retaining retractor is placed in the incision to obtain maximal exposure. There are several large veins in the loose areolar tissue and fat over the anterior capsule of the prostate. These should be suture ligated and divided; smaller vessels may be fulgurated to avoid troublesome bleeding.

The vesical neck can be visualized and palpated. Two traction sutures are placed in the prostatic capsule above and below the planned site of the capsular incision, which is made about 1 cm distal to the bladder neck. As the capsule is opened, one can recognize the white outer part of the adenoma. The length of the incision depends on the size of the gland and should be sufficient to dissect the adenoma.

The cleavage plane between the prostatic adenoma and the surgical capsule or true prostate is developed using Metzenbaum scissors. The dissection may be completed with scissors; in large adenomas, digital enucleation can easily be performed. The urethra is firmly attached at the apex. It is preferable to use scissors to incise the urethra sharply, keeping close to the prostatic adenoma to avoid causing injury to the sphincter and subsequent incontinence.

After removal of the prostatic adenoma, the fossa is inspected for any remaining nodules of adenoma and for sites of bleeding. The main sources of bleeding are the arteries at the 5- and 7-o’clock positions, which lie just distal to the bladder neck. Figure-of-eight suture ligatures of 2-0 chromic catgut are placed to secure hemostasis. Bleeding vessels in the prostatic fossa can be fulgurated under direct visualization. If the surgeon wears a headlight for illumination, visualization is much improved.

In some patients, the posterior lip of the vesical neck is prominent and protrudes into the lumen. This can be removed by wedge resection by grasping the midline with an Allis clamp, and, with either scissors or a knife, the wedge can be excised. A running suture may be placed for hemostasis.

A 22-Fr Silastic-coated three-way irrigating Foley catheter with a 30-cc retention balloon is inserted through the urethra into the bladder. The transverse incision of the prostatic capsule is then closed with a continuous suture of 2-0 chromic catgut or Vicryl, ensuring a watertight closure. Slight catheter traction is applied, and continuous bladder irrigation is instituted. If excessive bleeding from the prostatic fossa is noted, the source should be sought before wound closure. Suture placation of the prostatic fossa may be helpful. A suprapubic catheter is used only if there is significant bleeding.

A Penrose drain is placed into the space of Retzius and brought out through a stab wound lateral to the incision and sutured to the skin. The wound is irrigated, and the linea alba is closed with a running #2 nylon or #1 PDS suture. The skin is approximated with skin staples. A wound and drain dressing is applied.

Postoperatively, the Foley catheter is irrigated until it runs clear, and continuous bladder irrigation with saline is used for several hours. The catheter is usually removed on the fifth or sixth postoperative day. The Penrose drain is moved partially outward on that day and is removed the following day if no drainage occurs. The skin clips are removed, and sterile strips are applied.

Perineal Prostatectomy

The first operations for relief of urinary retention from prostatic enlargement were probably done through the perineum, and early medical writings contain references to division of the bladder neck through the perineum for this purpose. Covillard, in 1639, was apparently the first to remove a hypertrophied middle lobe by tearing it away with forceps after perineal lithotomy. In 1848, Sir William Fergusson exhibited specimens of hypertrophied prostates he had enucleated through the perineum after removal of bladder calculi. Kuchler, in 1866, formulated the first systematic technique for radical perineal prostatectomy, but his operations were done only in the cadaver. In 1867, Billroth used Kuchler’s method to carry out the first two intentional prostatectomies in living subjects. Apparently, however, the lobes were not entirely removed in these patients.

In 1873, Gouley advocated systematic enucleation of the lateral lobes and excision of the median lobe through the perineum. Goodfellow is credited4 as the first to perform a perineal prostatectomy successfully on a routine basis. His method involved the use of a midline vertical incision from the base of the scrotum to the anal margin, followed by incision of the membranous urethra, extension of the opening into the bladder, and complete enucleatlon of the prostatic lobes. His technique, although differing in certain respects from that used today, nevertheless forms the basis of current methods.

During the next decade, a number of technical modifications were suggested by Nicoll, Alexander, Albarran, Proust, dePezzer, Legueu, and others. For the most part, those changes were concerned with improving delivery of the prostatic lobes into the perineal incision for enucleation. In 1903, Young described his operative technique developed at the Johns Hopkins Hospital; this is still the approach most widely used. In 1939, Belt and colleagues introduced an important modification in the perineal approach to the prostate, which did much to reduce the risk of rectal injury inherent in the operations of Young and earlier surgeons. Belt’s method of closure also was a great improvement over earlier methods and shortened convalescence considerably.

Either spinal or general anesthesia can be used. Caudal block is also acceptable. With general anesthesia, tracheal intubation ensures adequate respiratory exchange.

Preoperatively, the patient should self-administer an enema to clean the lower bowel and rectum and receive appropriate antibiotics for a 1-day bowel prep. The genitalia are cleansed thoroughly, after which cystoscopy is performed. The entire operative area, from costal margins to midthigh, is then prepped. Bilateral vas ligation is now rarely performed.

Perfect positioning is essential for the perineal operation. The patient is placed in the exaggerated lithotomy position on any ordinary operating table. Sandbags are placed beneath the sacrum to position the perineum as close to horizontal as possible. The table is then elevated to bring the operative area up to the level of the operator’s chest. This makes the operation a good deal easier and improves visualization considerably. The perineum can usually be positioned adequately without resort to Trendelenburg’s position, but occasionally a slight Trendelenburg’s position may be necessary. Under no circumstances should shoulder braces be used for fear of causing postoperative brachial palsy. All other points where pressure is likely (e.g., popliteal areas) are carefully padded.

The curved Lowsley tractor is passed through the urethra and held upright with blades unopened. A curved skin incision is made about 1 cm from the anal margin. The anus is excluded from the operative field by being covered with a towel secured by three Allis clamps to the posterior edge of the incision. With the index fingers, the ischiorectal fossae are developed perpendicular to the plane of tile perineum. The central tendon is gently separated from the underlying rectum and cut across distal to the external anal sphincter, with care taken not to disturb that structure. A bifid posterior retractor is placed in the ischiorectal fossae, and gentle traction is exerted. The lateral fossae are developed next and held with two small lateral retractors. The rectourethralis muscle is identified and cut.

By carefully incising the pararectal fascia (posterior layer of Denonvillier’s fascia), the rectum can be gently peeled posteriorly off the apex of the prostate. The Lowsley tractor is passed fully into the bladder, and the blades are opened. The bifid posterior retractor is replaced by a plain posterior one (the lipped Richardson is useful here), with a moistened pad used to protect the rectum. The posterior layer of Denonvillier’s fascia is progressively incised and retracted posteriorly until a window appears through which the anterior layer of Denonvillier’s fascia—the “pearly gates”—can be seen clearly.

At this point, the operator simultaneously depresses the handle of the Lowsley tractor toward the abdominal wall and exerts firm downward traction on the posterior Richardson retractor. The remaining posterior fascial laver is thereby stripped away from the prostate, which comes clearly into view, covered only by the glistening anterior layer of Denonvillier’s fascia. This is a most effective maneuver, but it should not be done before dissection of the posterior fascial layer has been completed at the apex.

An inverted-V or curved prostatotomy is made, and a plane of cleavage is established with the dissecting scissors. Care is taken to peel back and preserve the posterior flap for subsequent closure of the prostatotomy. The urethra is incised, the curved Lowsley tractor is removed, and the regular Young prostatic tractor is inserted gently into the bladder through the prostatotomy, using a rotary motion. The blades of the tractor are then opened, the prostate is drawn down, and enucleation is begun.

As soon as possible, the urethra at the apex of the adenoma is cut across with the scissors, thereby facilitating enucleation distally and minimizing the danger of damage to the external urethral sphincter. Enucleation is carried out essentially under direct vision, using the scissors and the finger. Enucleation can sometimes be facilitated by removing the Young tractor and grasping the lobes with forceps that are especially designed for this purpose. The lobes can then be drawn progressively into the operative field. The hypertrophied lobes are cut away sharply from the bladder neck under direct vision. With care, the bladder neck can be preserved intact, even after removal of a large adenoma.

After enucleation has been completed, the bladder neck is grasped with Millin T-clamps, which were originally designed for the retropubic operation. These have the advantage of being offset so that one can obtain an unimpeded view of the bladder neck. A careful search is made for bleeding vessels (especially at the 5- and 7-o’clock positions). Smaller ones are controlled effectively by electrocoagulation. Larger arteries require mattress sutures of 2-0 plain catgut. The interior of the bladder is explored with the finger, and any blood clots are removed. The entire prostatic fossa is inspected carefully for residual adenomatous tissue. Remaining tags of tissue are trimmed away from the bladder neck.

A 22-Fr Foley catheter is passed through the urethra and into the bladder, where the balloon is inflated with 30 to 45 ml of water. The bladder neck, which feels like a soft cervical os dilated to about two fingerwidths, retains the balloon nicely. Wedge resection of the posterior lip is generally unnecessary. If desired, a three-way Foley, catheter may be used to permit through-and-through irrigations postoperatively.

Closure is simple. The edges of the prostatotomy are approximated with interrupted 2-0 chromic catgut sutures. The rectum is inspected for possible injury. No effort is made to bring the levator ani fibers together. A Penrose drain is left in the retroprostatic space. Skin edges are approximated with interrupted Dexon or Vicryl sutures. A simple dressing is applied to the wound, using a split-T binder. The lower extremities are brought down simultaneously and gradually. Too rapid depositioning may result in hypotension because of the sudden rush of blood into the legs, particularly if they have not been wrapped preoperatively.

Excessive bleeding is seldom encountered during perineal prostatectomy. If care is taken to obtain adequate exposure, bleeding vessels can usually be identified and secured without difficulty. The only other complication that may occur during the operation is laceration of the rectum, which is readily recognized from the characteristic appearance of the rectal mucosa. The injury should be completely mobilized and repaired with interrupted 4-0 chromic catgut sutures placed so that the mucosal edges are inverted. The muscularis should be closed in two additional layers, again using interrupted sutures of 4-0 chromic catgut.

If the injury is recognized before the urinary tract is opened, it is best to close the perineal incision and enucleate the gland through a suprapubic incision. If the rectal injury is not appreciated until after the urinary tract has been entered, the laceration should be repaired meticulously, as just outlined. Postoperatively, the patient should be maintained on a low-residue diet, and bowel activity should be completely suppressed with paregoric for 7 days.

After removal of the hypertrophied lobes, the raw surfaces of the prostatic fossa soon reepithelialize. The compressed outer prostate (prostate proper, or surgical capsule) eventually reexpands to normal size. Scattered areas of induration usually persist indefinitely and can be detected by rectal palpation.

Postoperatively, if a regular Foley catheter has been used, it is simply attached to straight bedside drainage. From time to time, gentle manual irrigation may be carried out to keep the system free of clots. The catheter is secured to the thigh, but no traction is necessary. If a three-way catheter has been used, it is attached to a through-and-through irrigating system containing sterile saline solution, which is run in just rapidly enough to keep the efflux reasonably clear. The patient is given appropriate antibiotics. Fluids may be given by mouth during the first day, and they are customarily supplemented by intravenous infusions to maintain a satisfactory intake.

The perineal Penrose drain is usually removed on the first postoperative day. At this time, the patient may be placed on a soft or regular diet and allowed out of bed. Early ambulation is encouraged.

Usually, the perineal wound heals benignly, but sometimes partial separation of the skin edges may occur. Healing may be promoted by removal of the dressing and exposure to a heat lamp. Warm sitz baths are also effective.

The urethral catheter is removed between the seventh and tenth postoperative days. Not infrequently, urinary leakage may occur from the wound for a day or two after the catheter has been taken out. If it continues longer than this, an 18-Fr, 5-ml Foley catheter may be reinserted for a day or two. Care must be taken in passing the catheter to be certain it does not curl up in the prostatic fossa. Sometimes a stylet is helpful, with the aid of a finger in the rectum.

During the immediate postoperative period, it is important that no rectal instrumentation be performed. No thermometers or rectal tubes should be inserted; this must be made clear to the nursing staff.

OUTCOMES

Complications

Hemorrhage

Delayed bleeding as occasionally seen after TURP is uncommon after open prostatectomy.

Infections

Wound infections occur in fewer than 5% of patients and are usually limited to the skin and subcutaneous tissue. Postoperative epididymo-orchitis is uncommon and may occur early or late. This complication is most commonly seen in patients who have had a long-term indwelling catheter or urinary tract infection.

Incontinence

Incontinence of urine is an uncommon complication of open prostatectomies and usually results from perforation and partial avulsion of the prostatic capsule or avulsion of the urethra at the apex of the prostate. With careful enucleation of the adenoma, the capsule is not perforated. With sharp excision of the urethra at the apex rather than avulsion, incontinence should not occur. Some patients may experience stress incontinence or urge incontinence, and detrusor instability may be the cause. In perineal prostatectomies, about 10% of patients experience some urinary incontinence for a few days after removal of the catheter. This disappears rapidly in the vast majority, but up to 6 months may be required for complete cessation of leakage in the occasional patient. Permanent incontinence is highly uncommon after an uneventful perineal prostatectomy.

Other Urologic Complications

In suprapubic and retropubic prostatectomies, urinary fistulas have been reported. Persistent perineal urinary fistula has been feared by those unfamiliar with perineal surgery; in actuality, this complication is rarely seen. Its occurrence should lead one to suspect some form of urethral obstruction, for example, a postoperative stricture.

Urethral stricture and bladder neck contracture occur most commonly as complications of transurethral resection and are uncommon after suprapubic prostatectomy. A single, gentle dilation with a urethral sound usually suffices to take care of this. Erectile dysfunction after prostatectomy should not occur unless the capsule has been violated. Retrograde ejaculation is common.

Other Complications

Rectal injury is a rare occurrence. Osteitis pubis is rarely seen but can be disabling. The condition is usually self-limited. Analgesics and anti-inflammatory drugs provide symptomatic relief.

Surgical mortality for open prostatectomy should be less than 1%; myocardial infarction, pneumonia, and pulmonary embolus are the most common causes. Early ambulation, leg movement in bed, and breathing exercises decrease morbidity.

Results

Enucleation of the enlarged prostatic adenoma by an open procedure is applicable in 5% to 10% of patients presenting with significant bladder outlet obstruction. The operative mortality and morbidity are minimal.