Open Versus Laparoscopic Radical Prostatectomy

Technique Update

TECHNIQUE UPDATE Open Versus Laparoscopic Radical Prostatectomy Herbert Lepor, MD Department of Urology, New York University School of Medicine, New York, NY Expert laparoscopic surgeons have demonstrated that laparoscopic radical prostatectomy with or without robotic assistance can be performed with excellent results. There is no evidence that laparoscopic radical prostatectomy with or without robotic assistance offers any clinically relevant advantage over open radical prostatectomy. Laparoscopic radical prostatectomy with or without robotic assistance requires a significant learning curve, is a longer surgical procedure, carries greater costs, and requires an expanded operating room team. The literature suggests that laparoscopic radical prostatectomy is associated with more intraoperative complications and higher positive surgical margins. The lesser amount of postoperative bleeding associated with laparoscopic radical prostatectomy is not clinically relevant. Laparoscopic radical prostatectomy is not associated with less pain and does not facilitate earlier urinary catheter removal. The best way to improve overall outcomes after radical prostatectomy is to direct patients to expert open or laparoscopic surgeons. [Rev Urol. 2005;7(3):115-127] © 2005 MedReviews, LLC Key words: Prostate cancer • Radical retropubic prostatectomy • Laparoscopy • Urinary incontinence • Potency • Blood loss • Catheterization • Postoperative pain adical perineal prostatectomy was first described as a curative treatment for prostate cancer by Hugh Hampton Young in 1904.1 The surgical procedure was associated with significant morbidity and mortality and often did not cure the disease, owing to the advanced stage at diagnosis. Approximately 70 years later, Jewett reported that survival after radical perineal prostatectomy approached that of the age-matched male population, provided the palpable abnormality was confined to 1 lobe of the prostate (stage B1 disease)2 or the disease was pathologically confined to the prostate.3 R VOL. 7 NO. 3 2005 REVIEWS IN UROLOGY 115 Open vs Laparoscopic Radical Prostatectomy continued Millin described the retropubic approach to radical prostatectomy in 1947.4 The advantage of the retropubic approach was that it provided the opportunity to perform a simultaneous pelvic staging lymphadenectomy through a single incision. Despite the increased blood loss associated with radical retropubic prostatectomy, urologists gravitated to this approach because they were generally more familiar with pelvic anatomy.5 Historically, both radical perineal and retropubic prostatectomies were considered technically challenging procedures, even for the experienced oncologic surgeon.5 These procedures were associated with a high incidence of removal of the urinary catheter, full return to activities (including strenuous exercise) within 3 weeks, and restoration of urinary continence.8 In the modern era, erectile dysfunction is the only intraoperative or postoperative problem likely to be encountered by men electing open radical prostatectomy.9 The introduction of the anatomic nerve-sparing radical retropubic prostatectomy has greatly decreased the incidence of erectile dysfunction.10 The treatment of postprostatectomy erectile dysfunction has been greatly advanced by the development of phosphodiesterase inhibitors11 and intracavernous injection therapy.12 Over the last few decades, advances in surgical technique, anesthetic agents, and intraoperative monitoring have all contributed to dramatic reductions in the morbidity of radical prostatectomy. intraoperative and postoperative complications. Some degree of stress urinary incontinence was common, and virtually all men developed erectile dysfunction. Over the last few decades, advances in surgical technique, anesthetic agents, and intraoperative monitoring; greater individual surgeon case volumes; and the development of surgical pathways have all contributed to dramatic reductions in the morbidity of radical prostatectomy.6 The widespread acceptance of prostate-specific antigen (PSA) screening has also dramatically increased the detection of “early” prostate cancers that are pathologically organ confined and therefore amenable to surgical cure.7 In 2005, a man undergoing an open radical retropubic prostatectomy by an experienced surgeon can expect the following: an uncomplicated surgical procedure, a short and uneventful hospital stay, the lack of allogeneic blood transfusion, “early” 116 VOL. 7 NO. 3 2005 Evolution of Laparoscopic Radical Prostatectomy Laparoscopy gained widespread acceptance by gynecologists because it represented an important adjunct to the diagnosis of female pelvic and adnexal pathology. Diagnostic laparoscopy has offered limited opportunities for urologists. In fact, the only appropriate indication for diagnostic laparoscopy is the localization of an impalpable testis in children.13 Therefore, the adoption of laparoscopy within the urologic community required identifying a role in surgical management. The first application of laparoscopy in urology focused on pelvic lymphadenectomy before radical prostatectomy.14 The enthusiasm for laparoscopic pelvic lymphadenectomy before open radical prostatectomy was limited because of the requirement for a second anesthetic. Owing to the favorable stage migration attributable to PSA screening, the overall incidence of REVIEWS IN UROLOGY positive pelvic lymph nodes in surgical candidates became extraordinarily low.15 The urologic community appropriately failed to embrace laparoscopic pelvic lymphadenectomy because the disadvantages far exceeded the benefits. The enthusiasm for laparoscopic urologic surgery resurfaced in the early 1990s, when Clayman and associates16 performed the first laparoscopic nephrectomy. With increasing laparoscopic experience, modifications in surgical technique, and improvements in laparoscopic equipment, laparoscopic nephrectomy was eventually shown to have complication rates comparable to those of open radical nephrectomy.17,18 With the exception of very large renal masses or renal cell carcinomas with vena caval involvement, laparoscopic nephrectomy for renal cell carcinoma has become the standard of care in most academic institutions and in community practice. Expert laparoscopic oncologic surgeons have extended laparoscopic indications to include partial nephrectomy.19 The advantages of laparoscopic renal surgery are compelling: it avoids a painful flank or abdominal incision, requires a shorter hospital stay, and allows for a quicker return to activities.17,18 As urologic surgeons gained technical expertise with laparoscopic nephrectomy, the next frontier was to extend laparoscopic surgery to more challenging reconstructive procedures, including radical prostatectomy. Several expert laparoscopic oncologic surgeons have demonstrated that radical prostatectomy with or without robotic assistance can be performed with good outcomes.20-32 Debate currently focuses on whether the outcomes associated with laparoscopic radical prostatectomy are superior to those of open radical prostatectomy. It is imperative to Open vs Laparoscopic Radical Prostatectomy demonstrate that the laparoscopic approach is superior to open radical prostatectomy to justify the increased cost and the morbidity associated with its learning curve. golf and tennis within 1 week of open radical retropubic prostatectomy. One 57-year-old man competed in a national track and field event 17 days after an open radical prostatectomy Unlike arguments supporting the use of laparoscopy in renal surgery, the arguments supporting laparoscopic radical prostatectomy are tenuous. Unlike arguments supporting the use of laparoscopy in renal surgery, the arguments supporting laparoscopic radical prostatectomy are tenuous. Open radical retropubic or perineal prostatectomy in the modern era is performed through a small lower abdominal or perineal incision, which is associated with minimal discomfort. It is the author’s practice to allow men to return to unrestricted activities within 3 weeks of open radical retropubic prostatectomy. Many men will resume activities such as Figure 1. Seventeen days after open radical prostatectomy, this 57-year-old man (no. 794, center) competed in the National USA Track & Field finals. and placed third in the quarter mile event (Figure 1). One cannot assume that a laparoscopic radical prostatectomy is more minimally invasive, even if the definition is based solely on the time to resume physical activities. A definition of “minimally invasive” should also include operative time, technical complications, transfusion rates, pain control, and timing of catheter removal. Unlike laparoscopic nephrectomy, which is entirely extirpative, radical prostatectomy requires dissection of the neurovascular bundle off the prostate without incising the capsule, placement and tying of anastomotic sutures, and reconstruction of the bladder neck. There is no compelling evidence that a laparoscopic approach facilitates these maneuvers. The “minimally invasive” advantages of laparoscopic radical prostatectomy, with or without robotic assistance, must ultimately be proved with an evidencebased approach. Open Versus Laparoscopic Radical Prostatectomy: Theoretic Advantages and Disadvantages The primary advantages offered in support of laparoscopic radical prostatectomy are as follows: faster recovery because one avoids a lower midline incision; less blood loss due to the pneumoperitoneum; better preservation of the neurovascular bundle due to magnification; and a better vesicourethral anastomosis because the placement and tying of the anastomotic sutures are performed under direct vision. The disadvantages of laparoscopic radical prostatectomy according to surgeons who prefer to perform open procedures are that the pneumoperitoneum increases the risk of postoperative ileus; the loss of proprioception with the laparoscopic approach increases positive surgical margins; an expanded operating room team is required for laparoscopic radical prostatectomy; laparoscopic radical prostatectomy is more costly; mobilization of the neurovascular bundle with electrocautery results in thermal injury to the cavernous nerves31; and the laparoscopic approach is technically more difficult and associated with greater complications (Tables 1 and 2). In addition, the assumption that laparoscopic radical prostatectomy is associated with less pain, a better vesicourethral anastomosis, and quicker recovery is not supported by evidence-based medicine. Methodology for Comparing Open Versus Laparoscopic Radical Prostatectomy The ideal way to compare open versus laparoscopic radical prostatectomy is a randomized study using common clinical pathways. Unfortunately, this study is not feasible because both expert surgeons and patients have their bias regarding the optimal technique and therefore will not submit to randomization. The other option is to compare concurrent series of open versus laparoscopic radical prostatectomy performed by expert surgeons at the same institution, using similar outcome instruments and clinical pathways. It is inappropriate for expert laparoscopic surgeons advocating laparoscopic radical prostatectomy to compare their outcomes with those of open radical prostatectomies performed concurrently25,30 or VOL. 7 NO. 3 2005 REVIEWS IN UROLOGY 117 Open vs Laparoscopic Radical Prostatectomy continued Table 1 Advantages of Laparoscopic Radical Prostatectomy Claims by Laparoscopic Surgeons Rebuttal by Open Surgeons Magnification improves visualization Magnification achievable with surgical loops Less blood loss Not clinically relevant, based on similar transfusion rates Improved visualization allows for more precise dissection of the prostatic apex and neurovascular bundle Quality of life outcomes fail to show advantages for continence or potency Avoidance of lower abdominal incision decreases postoperative pain and facilitates return to activities Postoperative pain is comparable, and men can return to activities just as quickly despite an incision Watertight urethrovesical anastomosis allows for earlier catheter removal No difference in achieving watertight vesicourethral anastomosis at postoperative day 3; urinary catheters typically removed at 1 week after both approaches nonconcurrently32 by low-volume, nonexpert open surgeons. It is imperative that the clinical pathways are similar for the different surgical procedures. Specifically, the criteria for allogeneic blood transfusion, administration of narcotics, hospital discharge, catheter removal, and return to activities must be uniform. Similar outcome instruments must be used for quantifying continence and potency. There must be assurances that the data were collected prospectively, that the surgeon did not have the opportunity to censor any data, and that there was complete follow-up. Unfortunately, to date there are no large-scale comparative studies with long-term follow-up Table 2 Disadvantages of Laparoscopic Radical Prostatectomy that allow a definitive comparison between open and laparoscopic radical prostatectomy. This article reviews all relevant literature indexed in PubMed as of March 2005 to apply an evidence-based approach to comparing open and laparoscopic radical prostatectomy. The outcomes after radical prostatectomy are presented on the basis of the authors’ opinion regarding their ranked order of clinical importance (Table 3). Cancer Control The most important objective of radical prostatectomy is to cure prostate cancer.6 The overwhelming majority of biochemical recurrences will become evident within the first 5 postoperative years.33 Because prostate cancer is generally slow-growing, biochemical evidence of disease recurrence after radical prostatectomy might take more than 10 years to become clinically detectable.33 Therefore, it will require many years before the true impact of laparoscopic radical prostatectomy on cancer control is known. The finding of a positive surgical margin is an independent predictor of biochemical recurrence, especially in Table 3 Outcomes After Radical Prostatectomy: Ranked Order Based on Clinical Importance Claims by Open Surgeons Rebuttal by Laparoscopic Surgeons Lack of proprioception compromises cancer control Positive margin rates equivalent Technical complication rates lower with open surgery Complication rates after laparoscopic radical prostatectomy decrease with increasing experience Mobilizing the neurovascular bundle with electrocautery damages these structures Similar potency rates Significant learning curve Proctoring reduces learning curve • Timing of catheter removal Longer operative time No rebuttal • Length of hospital stay Increased cost No rebuttal • Postoperative pain 118 VOL. 7 NO. 3 2005 REVIEWS IN UROLOGY • Cancer control • Technical complications • Postoperative complications • Urinary continence • Erectile function • Cost • Blood loss Open vs Laparoscopic Radical Prostatectomy patients with extracapsular extension and high-grade disease.34-36 It is important to recognize that a positive surgical margin does not always indicate the presence of residual disease or that a negative margin assumes total eradication of the disease. Many men with positive margins will not develop biochemical disease recurrence, whereas others with both negative margins and organ-confined disease will develop disease recurrence.33,35 The apical soft tissue margin is the most common site of positive surgical margins.37 The occurrence of true apical positive margins might be reduced by excising and submitting the actual apical soft tissue margin for frozen section examination during the radical prostatectomy.38,39 It is the author’s practice to routinely excise a 2- to 3-mm circumferential biopsy from the apical soft tissue margin and submit the specimen for frozen section pathologic examination during radical prostatectomy. In patients with greater than 10% cancer in the apical soft tissue biopsy, additional apical soft tissue is typically excised. The author believes that the apical soft tissue biopsy is a more reliable indicator of margin status than the examination of the apical portion of the surgical specimen.38 This opinion is based on the observation that no individuals with a solitary positive margin at the apex on the surgical specimen and a negative apical soft tissue biopsy have developed disease recurrence, with a mean follow-up of 19.1 months.38 It is important that surgeons stipulate whether margin status is based on the surgical specimen or additional submitted tissue. Positive margin rates depend on surgical technique,40 the pathologist’s criteria for assigning positive margins,41 patient selection,35,42 the date of surgical intervention,43 and whether margin status is based on the surgical specimen or additional tissue sampling.38,39 Therefore, comparison of positive margin rates between laparoscopic and open radical prostatectomy ideally should compare cases from the same time era, with similar criteria utilized for assigning positive margins. Positive margin rates should also be reported independently for cases that are pathologically organ confined (pT2) versus those with extracapsular extension (pT3). A positive margin in men with pathologically organ-confined disease is most likely attributable to a breach of technique from an inadvertent capsular incision. Lower positive margins in men with extracapsular extension might be achieved by excising wider margins in those cases at greater risk for having positive margins. Recognizing all of the abovementioned pitfalls for comparing positive margin rates between open and laparoscopic radical prostatectomy at different institutions, the literature is summarized in Table 4 for those series stratifying positive margin rates according to pathologic stage. All of the laparoscopic series enrolled patients after 1998. The vast majority of the modern literature on margin status after open radical prostatectomy Table 4 Positive Surgical Margins After Radical Prostatectomy Positive Margins (%) Institution Patients, N Lepor* New York University 1000 2.9 Roumeguere et al (21)† Erasme Hospital 77 7.3 Klein et al (44) Cleveland Clinic 152 7.4 Author(s) (Reference) pT2 Disease pT3 Disease Study Period Open radical prostatectomy 33.2 2000-2005 1999-2001 29.6 1994-1996 Laparoscopic radical prostatectomy Rassweiler et al (32) University of Heidelberg Guillonneau et al (28) Montsouris Institute Menon et al (26) Henry Ford Ruiz et al (20) Henri Mondor † Roumeguere et al (21) Erasme Hospital 438 9.7 37.1 1999-2002 1000 15.5 31.1 1998-2002 100 11 40 2001-2002 330 15.3 44.3 2000-2002 85 7.8 1999-2001 *Unpublished data. † Concurrent studies at same institution. VOL. 7 NO. 3 2005 REVIEWS IN UROLOGY 119 Open vs Laparoscopic Radical Prostatectomy continued includes men undergoing surgery before 1998.35-37,43 There is no open radical prostatectomy series reporting positive margin rates based on men undergoing surgical intervention after 1998. We therefore reviewed our positive margin rates for a consecutive series of 1000 men undergoing open radical retropubic prostatectomy between the years 2000 and 2005 (unpublished data). The cumulative data suggest that laparoscopic radical prostatectomy with or without robotic assistance has higher positive margin rates compared with open radical prostatectomy in pT2 disease. Touijer and associates45 recently reported a positive margin rate of only 5.4% in men with pT2 disease who underwent bilateral nerve-sparing laparoscopic radical prostatectomy between January 2003 and May 2004. They attributed the declining positive margin rate to improved technique after review of intraoperative video recordings. It is important to recognize that this low positive margin rates is limited to those men with pT2 disease undergoing bilateral nervesparing procedures and not all men with pT2 disease. The experience of Touijer and colleagues suggests that surgical margins are compromised by technical errors even after expert laparoscopic surgeons have performed more than 1000 operations. Fromont and associates46 reported on a series of cases in which they routinely submitted frozen section biopsies obtained from the posterolateral surface of the radical prostatectomy specimens in men undergoing preservation of the neurovascular bundles. In 84 cases (17.3%), the submitted surgical margin was positive, and additional tissue was sent from the tissue presumed to be contiguous to the positive margin. Hernandez and associates47 recently reported that 84% of men with extracapsular extension in the area of the neurovascular bundle 120 VOL. 7 NO. 3 2005 underwent a nerve-sparing procedure. In those patients with extracapsular extension in the area of the preserved neurovascular bundle, the positive surgical margin rate was only 5.9%. The fact that the incidence of positive margins in the area of the neurovascular bundle in men with extracapsular extension undergoing nerve-sparing open radical retropubic prostatectomy reported by Hernandez is lower than the rate for all men undergoing nervesparing laparoscopic radical prostatectomy reported by Fromont provides additional evidence that laparoscopic radical prostatectomy might compromise cancer control. Technical Complications Technical complications after open and laparoscopic radical prostatec- tween October 2000 and August 2002. All intraoperative and postoperative complications and pertinent outcomes information were recorded by urology residents during the hospitalization, and the data sheets were submitted directly to a data manager. All men were interviewed by a urology nurse specialist 1 month after surgery, so that all postoperative complications could be captured. This is important because some men seeking care at a tertiary center may pursue their follow-up care within their local community, which could lead to underreporting of complications. The only intraoperative complication recorded was a single ureteral injury, which occurred in a man from Kenya who failed to report a prior history of schistosomiasis. The ureter was en- Technical complications after open and laparoscopic radical prostatectomy include injury to the small bowel, sigmoid colon, rectum, bladder, ureter, iliac and epigastric vessels, and nerves. Technical complications are higher following the laparoscopic approach. tomy include injury to the small bowel, sigmoid colon, rectum, bladder, ureter, iliac and epigastric vessels, and nerves. Nerve injuries might occur after ligation of the obturator nerve or neurapraxia from positioning. Medical complications include deep vein thrombosis, pulmonary embolus, myocardial infarction, cerebral vascular accident, and prolonged ileus. Only Guillonneau and colleagues,29 Ruiz and colleagues,20 and Lepor and Kaci39 have published large prospective studies capturing intraoperative and postoperative complications after open or laparoscopic radical prostatectomy (Table 5). Lepor and Kaci39 reported complications and outcomes in a consecutive series of 500 men undergoing open radical retropubic prostatectomy performed by a single surgeon be- REVIEWS IN UROLOGY cased in a dense desmoplastic reaction, and the injury was identified 1 week postoperatively. A ureteroneocystostomy was performed, with resolution of the obstruction and preservation of renal function. Guillonneau and colleagues29 and Ruiz and colleagues20 reported on the intraoperative and postoperative complications associated with laparoscopic radical prostatectomy on the basis of prospective series of 567 and 330 consecutive cases, respectively. In none of the laparoscopic series was a telephone interview conducted to ensure that complications were not underreported. Among expert surgeons, laparoscopic radical prostatectomy has a slightly higher intraoperative complication rate compared with open radical prostatectomy, which argues Open vs Laparoscopic Radical Prostatectomy Table 5 Complication Rates Associated With Radical Prostatectomy, According to Prospective Studies Open Radical Prostatectomy (%) Complications Lepor and Kaci (39), N
500 Laparoscopic Radical Prostatectomy (%) Guillonneau et al (29), N
567 Ruiz et al (20), N
330 Rectal injury 0 1.4 1.8 Ileocolonic injury 0 0.9 0 Rectal fistula 0 NR NR Ureteral injury 0.2 0.7 NR Bladder injury 0 NR NR Nerve injury 0 0.5 NR Vascular injury 0 0.5 0 Wound complications 0.2 0.7 1.5 Urinoma 0 NR NR Myocardial infarction 0.4 NR NR Pulmonary embolus 0 NR NR Deep venous thrombosis 0.4 0.3 NR Cerebral vascular accident 0 NR NR Prolonged ileus 0.4 1 1.5 Lymphocele 0 0 0.3 NR, not reported. against the claim that it is a more minimally invasive procedure. Medical complications associated with radical prostatectomy are dependent on operative time, blood loss, and patient selection. Men with significant cardiovascular or pulmonary comorbidities typically are not encouraged to undergo radical prostatectomy. The rates of medical complications in the prospective open and laparoscopic series performed by experts are very low and comparable. Urinary Incontinence Urinary incontinence is a complication of radical prostatectomy that negatively impacts quality of life. It is generally agreed that incontinence after radical prostatectomy should be mea- sured with self-administered diseasespecific quality-of-life instruments.48,49 The overwhelming majority of men spontaneously achieve continence within 12 months of the surgical procedure.50 The slight increase in con- Another limitation when comparing continence rates between different surgical approaches is the lack of a standardized definition of continence. Continence might be defined according to pad use, bother due to incontinence, or the degree of incontinence.51-54 Lepor and colleagues51 have correlated patients’ global perceptions of continence after open radical prostatectomy with individual responses to the University of California-Los Angeles Prostate Cancer Index capturing pad use, bother due to incontinence, and degree of incontinence. Men with total control or occasional dribbling, men requiring no pads or a single pad over a 24-hour interval, and men with no or slight bother due to incontinence consistently considered themselves continent, thereby legitimizing these definitions of continence after radical prostatectomy. There is a paucity of large open and laparoscopic radical prostatectomy series that have prospectively evaluated continence rates with self-administered disease-specific quality-of-life questionnaires. Historically, the majority of the continence data reported by expert open surgeons was not obtained with these objective instruments because they were developed in the mid-1990s. These large, single-surgeon studies consistently reported continence rates greater than 90%.54-56,57 Another limitation when comparing continence rates between different surgical approaches is the lack of a standardized definition of continence. tinence rates observed between 1 and 2 years is partly due to incontinence procedures restoring continence and spontaneous improvement in function (unpublished data). Therefore, it is important for investigators to report the percentage of men undergoing invasive measures to restore continence. The few consecutive series that have prospectively evaluated continence after open50,53,56,57 and laparoscopic58,59 radical prostatectomy with self-administered disease-specific questionnaires along with a validated definition of continence are summarized in Table 6. VOL. 7 NO. 3 2005 REVIEWS IN UROLOGY 121 Open vs Laparoscopic Radical Prostatectomy continued Table 6 Continence Rates After Radical Prostatectomy, According to Disease-Specific Self-Administered Quality-of-Life Instruments Continence Assessment Author(s) (Reference) Institution Patients, N Continent* (%) Open radical prostatectomy Lepor et al (51) New York University 580 98.5 Wei et al (52) University of Michigan 482 97.7 Young et al (53) Duke University 92 97.8 Laparoscopic radical prostatectomy Olsson et al (58) Henri Mondor 36 100 Link et al (59) Johns Hopkins 122 93 *Minimum of 12 months follow-up. Two prospective studies have compared continence and urinary quality of life after open and laparoscopic radical prostatectomy by comparably skilled surgeons. Roumeguere and colleagues21 compared continence rates between open and laparoscopic radical prostatectomy but failed to indicate whether self-administered disease-specific questionnaires were used. The continence rates at 1 year were comparable. Namiki and colleagues60 also compared urinary quality of life for men undergoing open and laparoscopic radical prostatectomy at their institution. They reported a slight advantage with open radical prostatectomy at 1 year. Overall, the continence rates achieved by expert surgeons after open and laparoscopic radical prostatectomy are uniformly excellent. outcome instruments, for many reasons. The disease-specific questionnaires do not differentiate whether the reported sexual function is captured “on” or “off ” therapy. Ideally, potency rates should be reported independently “on” or “off ” therapy.62 The likelihood of regaining potency is also time dependent.63 The return of erectile function should be reported with a minimum of 18 months of follow-up data. Recent studies have suggested that erectile function continues to improve in some men years after radical prostatectomy.64 Age, experience of the surgeon, nervesparing status, baseline quality of Some couples might have extremely satisfactory sexual intimacy without intercourse, whereas others who have regained their erections might not have a sexual partner and therefore do not report that they are engaging in intercourse. Without uniform methods for defining and assessing erectile sexual function and sexual satisfaction, comparison of reported potency rates will not resolve the question of which surgical approach achieves superior potency outcomes. Historically, expert surgeons have reported potency rates after open radical prostatectomy ranging between 68% and 71%. These potency rates were based on retrospective chart reviews.55,56,66 Twiss and colleagues62 recently reported potency rates based on a prospective study of consecutive men undergoing open radical retropubic prostatectomy. Men were interviewed by a nurse specialist at 3, 6, 12, and 24 months after radical retropubic prostatectomy. Of the potent men at baseline who underwent a bilateral nerve-sparing procedure, 83.5% indicated that they were having erections firm enough for intercourse. Overall, 64.5% of men were having erections firm enough for intercourse without assistance from intracavernous or intraurethral therapy or vacuum devices. Younger men were found to have significantly better potency outcomes. Age, experience of the surgeon, nerve-sparing status, baseline quality of erections, baseline sexual activity, stability of relationships, and cardiovascular comorbidities all contribute to the final potency status. Potency Ideally, potency must also be ascertained prospectively with selfadministered disease-specific questionnaires.61 The impact of radical prostatectomy on sexual function is very difficult to ascertain, even when using quantitative disease-specific 122 VOL. 7 NO. 3 2005 erections, baseline sexual activity, stability of relationships, and cardiovascular comorbidities all contribute to the final potency status.65 There is no consensus regarding the optimal instrument for assessing potency and a definition of potency. REVIEWS IN UROLOGY There is a paucity of potency data acquired after laparoscopic radical prostatectomy, owing to limited follow-up. Link and colleagues59 reported a mean 75% recovery of baseline sexual function at 1 year after laparoscopic radical prostatectomy in Open vs Laparoscopic Radical Prostatectomy men undergoing a bilateral nervesparing procedure, based on the expanded prostate cancer index composite. Roumeguere and colleagues21 and Namiki and colleagues60 reported the only concurrent comparison of open versus laparoscopic radical prostatectomy at their institutions. Roumeguere and colleagues reported comparable potency rates at 1 year, whereas Namiki and colleagues reported delayed return of sexual function with laparoscopic radical prostatectomy. At present, any claims of superior outcomes related to potency for open or laparoscopic radical prostatectomy cannot be justified. Cost A cost comparison of open versus laparoscopic radical prostatectomy must include operating room time, personnel costs, disposable instruments, purchasing and maintenance of the robot, consumption of blood products, length of stay, and management of complications. The cost allocated per case for robot-assisted radical prostatectomy and its maintenance depends on the surgical volume at a given institution. A cost analysis based on an institution performing 500 robotic radical prostatectomies cannot be extrapolated to major academic centers and the general community hospital setting, where surgical volumes are far less. In the hands of expert surgeons, laparoscopic radical prostatectomy performed in centers of excellence is a longer procedure, requires more highly trained personnel, utilizes more disposable equipment, has a comparable hospital stay, and is associated with higher complication rates. All of the cost comparisons reported to date have confirmed that laparoscopic radical prostatectomy with or without robotic assistance is more costly than open radical prostatectomy.67,68 Blood Loss There is general agreement that laparoscopic radical prostatectomy with or without robotic assistance is associated with less blood loss due to the pneumoperitoneum. The clinical significance of blood loss depends on rates of allogeneic blood transfusion and discharge hematocrit. The transfusion rate is marginally significant because of the exceedingly low risk of transmission of viral diseases like hepatitis and human immunodeficiency virus.69 The discharge hematocrit likely influences the time to resume physical activities and return to work. The rate of allogeneic blood transfusion reported by experts performing open39,53,70-73 and laparoscopic20,22,28,30,71 surgery is summarized in Table 7. There seem to be no clinically significant differences between transfusion rates among expert surgeons performing open versus laparoscopic radical prostatectomy. The discharge hematocrit likely influences the time required for men to resume physical activities and return to employment after radical prostatectomy. Men who preoperatively donate autologous blood become anemic preoperatively, and the banked units are often not transfused unless clinically indicated. Therefore, men often are discharged with hematocrit levels less than 30 despite having autologous units available.74 The author encourages the use of preoperative recombinant erythropoietin for all men undergoing open radical prostatectomy, both to decrease the risk of allogeneic transfusion and to increase discharge hematocrit.75 Preoperative administration of recombinant erythropoietin increases the hematocrit, on average, by 4% units.76 The mean discharge hematocrit in men undergoing radical prostatectomy who received preoperative recombinant erythropoietin was Table 7 Transfusion Rates After Radical Prostatectomy Allogeneic Blood Transfusion Author(s) (Reference) Institution Patients, N Receiving Transfusion (%) Open radical prostatectomy Smith (71) Vanderbilt University NR 3.0 Koch and Smith (72) Vanderbilt University 124 2.4 Lepor and Kaci (39) New York University 500 4.6 Goh et al (73) University of Michigan 200 5 Leandri et al (56) Saint-Jean LanguedocCerou 620 1.3 Andriole et al (70) Washington University 1342 11.5 Laparoscopic radical prostatectomy Brown et al (22) Massachusetts General 156 2.6 Rassweiler et al (32) University of Heidelberg 438 19.9 Ruiz et al (20) Henri Mondor 330 3.3 Smith (71) Vanderbilt University NR 0 Guillonneau et al (29) Montsouris Institute 567 4.9 NR, not reported. VOL. 7 NO. 3 2005 REVIEWS IN UROLOGY 123 Open vs Laparoscopic Radical Prostatectomy continued 34%.76 This is only slightly lower than discharge hematocrit levels reported after laparoscopic radical prostatectomy.22 Koch and Smith72 reported that the discharge hematocrit was 5% units higher after laparoscopic radical prostatectomy compared with open radical prostatectomy. None of the men received any preoperative blood management intervention. The use of preoperative recombinant erythropoietin in men undergoing open radical prostatectomy by Koch and Smith would have eliminated the advantage of laparoscopic radical prostatectomy. Timing of Catheter Removal Until recently, the urinary catheter was typically left indwelling between 2 and 3 weeks after radical prostatectomy. Lepor and associates77 reported that the urinary catheter is a significant bother for many men undergoing radical prostatectomy. Over the past 5 years, the author has been investigating the optimal timing for catheter removal after radical prostatectomy, to minimize both postoperative discomfort and complications. Hypothetical complications of premature removal of the catheter include acute urinary retention, complications resulting from catheter reinsertion, pelvic abscess, and anastomotic stricture formation. Lepor and colleagues’ first report of early catheter removal demonstrated that 78% of men had no extravasation on gravity cystography performed on postoperative day 7.77 Urinary catheters were removed in the absence of extravasation, and 15.2% of these men experienced acute urinary retention, prompting reinsertion of the catheters without sequelae.77 With the exception of a higher incidence of acute urinary retention, there were no complications associated with early catheter removal. These favorable outcomes encouraged Lepor and associates to attempt 124 VOL. 7 NO. 3 2005 catheter removal on postoperative day 3.78 Approximately 80% of consecutive men undergoing radical prostatectomy were found to have no evidence of extravasation on cystograms performed on the third or fourth postoperative day. In patients without extravasation, the catheters were removed immediately after the cystogram. Twenty percent of these men experienced acute urinary retention requiring replacement of the urinary catheter. Overall, 2 men (1.5%) experienced complications requiring reoperation. Because of the discomfort and inconvenience of acute urinary retention and the slight risk of disruption of the anastomosis at the time of catheter replacement, the author no longer attempts to remove the urinary catheter on postoperative day 3. no extravasation on cystography performed between 2 and 4 days after laparoscopic radical prostatectomy. The catheters were removed in the absence of extravasation, and the incidence of acute urinary retention was 10.4%. The likelihood of achieving a watertight anastomosis on postoperative day 3 after laparoscopic radical prostatectomy is similar to that reported after open radical prostatectomy.78 The rates of acute urinary retention after attempts to remove the catheter on the third day after laparoscopic and open radical prostatectomy are both unacceptably high.78,80 Therefore, experts performing open71,79 and laparoscopic radical prostatectomy with or without robotic assistance20,29,71 typically remove the urinary catheters on or about postoperative day 7. Of the 93.5% of men who had their catheters removed on postoperative day 8, only 2.6% developed acute urinary retention. To decrease the incidence of acute urinary retention, the author prescribes 7 days of the -blocker tamsulosin (0.4 mg daily), beginning on the fourth postoperative day. Cystograms are routinely performed on postoperative day 8, and catheters are removed if there is no extravasation. Of the 93.5% of men who had their catheters removed on postoperative day 8, only 2.6% developed acute urinary retention.79 We attribute the lower incidence of acute urinary retention to pretreatment with tamsulosin. Laparoscopic surgeons claim that the ability to visualize the urethra while performing a running vesicourethral anastomosis results in a greater likelihood of achieving a watertight anastomosis, thereby facilitating earlier catheter removal. Nadu and colleagues80 reported that 85% of vesicourethral anastomoses showed REVIEWS IN UROLOGY Length of Hospital Stay Length of hospital stay depends primarily on the criteria influencing discharge. The length of stay reported after open radical prostatectomy is now typically 2 days.39,72 The author discharges patients to home only if they are afebrile for 12 hours, tolerating a regular diet, and under good pain control with oral analgesics. In more than 95% of cases, the pelvic drain is removed before discharge. Length of hospital stay can be reduced if men are discharged without tolerating a regular diet, which is often done after laparoscopic procedures. Patients might be more amenable to leaving the hospital on postoperative day 1 if they are discharged to a nearby hotel in close proximity to the hospital rather than flying or driving hundreds of miles to home. The difference in length of stay Open vs Laparoscopic Radical Prostatectomy after open versus laparoscopic radical prostatectomy is primarily influenced by surgeon preference, patient motivation, and criteria for discharge. The length of stay for men undergoing laparoscopic radical prostatectomy in large series from France and Germany was 6.5 and 11 days, respectively,29,32 whereas the average length of stay in the United States is between 1 and 2 days.22,30,71 When pathways are designed to facilitate early discharge from the hospital, there is no significant difference in length of stay between open versus laparoscopic radical prostatectomy.71 Postoperative Pain There is no reason to believe that using multiple incisions for port entry and an infraumbilical incision to remove the surgical specimen is associated with less discomfort than a 10- to 15-cm lower midline incision, especially when the incision is routinely infiltrated with bupivacaine. In addition, the introduction of a pneumoperitoneum increases the probability of postoperative discomfort due to ileus.29,32 The use of narcotic analgesia is also a poor indicator of postoperative pain control because some surgeons might routinely offer narcotics as a first-line option for pain management, whereas others reserve narcotic use for cases of severe pain refractory to nonsteroidal anti-inflammatory agents.71 The only meaningful way to compare analgesic use between open and laparoscopic radical prostatectomy is to use the same clinical pathway and to ascertain pain with a quantitative scale. A recent study by Smith,71 who compared open and laparoscopic radical prostatectomies performed by the same surgeon by using a common pathway for administration of analysis and an objective scale of pain, showed no advantage of the laparoscopic approach in terms of postoperative pain. Activity Restriction The notion that men must restrict their activities for a prolonged period of time after a lower midline incision is not supported by evidence-based medicine. Over the last 10 years, the author has encouraged men to return to unrestricted activities within 3 weeks of radical prostatectomy. Only 1 of 2000 patients developed an incisional lesion. It is the author’s experience that the urinary catheter limits return to activities far more than postoperative discomfort.78 When the urinary catheter was removed on postoperative day 3 or 4, men were golfing or playing tennis by the fifth postoperative day. At 3 weeks, men were hiking, biking, sky diving, horseback riding, and running in national track competition events. There is no physiologic reason and complications and higher positive surgical margins. The lesser amount of postoperative bleeding associated with laparoscopic radical prostatectomy is not clinically relevant. Laparoscopic radical prostatectomy is not associated with less pain and does not facilitate earlier urinary catheter removal. An earlier return to activities is also not a proven advantage. Overall, laparoscopic radical prostatectomy offers no clinically relevant advantages for men with localized prostate cancer. At best, it is a step sidewise rather than forward. The enthusiasm for laparoscopic radical prostatectomy in the short term might prove to be problematic as urologists feel market pressures to learn the technique and subject their patients to a new learning curve. For those experts who perform open radical There is no physiologic reason and there is no objective evidence that laparoscopic radical prostatectomy offers a more rapid recovery. there is no objective evidence that laparoscopic radical prostatectomy offers a more rapid recovery. Summary Expert laparoscopic surgeons have demonstrated that laparoscopic radical prostatectomy with or without robotic assistance can be performed with excellent results. There is absolutely no evidence that laparoscopic radical prostatectomy with or without robotic assistance offers any clinically relevant advantage over open radical prostatectomy. Laparoscopic radical prostatectomy with or without robotic assistance requires a significant learning curve, is a longer surgical procedure, carries greater costs, and requires an expanded operating room team. The literature suggests that laparoscopic radical prostatectomy is associated with more intraoperative prostatectomy, the real limitation is postprostatectomy erectile dysfunction. There is no reason to believe that laparoscopic radical prostatectomy offers an opportunity to significantly improve potency outcomes. The improvements in erectile dysfunction will not come from adopting laparoscopic radical prostatectomy, but rather will depend on the development of pharmacologic interventions that prevent apoptosis of the cavernous nerve or that more effectively restore erectile function. Wisdom would dictate that laparoscopic radical prostatectomy would have to offer considerable advantages as a minimally invasive procedure to justify its adoption without documented evidence of equivalent cancer control. To state that laparoscopic radical prostatectomy cannot be performed by expert surgeons with VOL. 7 NO. 3 2005 REVIEWS IN UROLOGY 125 Open vs Laparoscopic Radical Prostatectomy continued excellent results is misleading. To claim that open radical prostatectomy is obsolete and should be relegated to the historical archives is equally irresponsible. The best way to improve overall outcomes after radical prostatectomy is to direct patients to expert surgeons. 10. References 13. 1. Young HH. The early diagnosis and radical cure of carcinoma of the prostate: a study of 40 cases and presentation of a radical operation which was carried out in four cases. Johns Hopkins Hosp Bull. 1905;16:315-321. Jewett HJ. The results of radical perineal prostatectomy. JAMA. 1969;210:324-325. Elder JS, Jewett HJ, Walsh PC. Radical perineal prostatectomy for clinical stage B2 carcinoma of the prostate. J Urol. 1982;127:704-706. Millin T. Retropubic Urinary Surgery. London: Livinstone; 1947. Walsh PC, Lepor H. The role of radical prostatectomy in the management of prostatic carcinoma. Cancer. 1987;60(3 suppl):526-537. Lepor H. Radical prostatectomy: status and opportunities for improving outcome. Cancer Investig. 2004;22:435-444. Taneja SS. The rationale for early detection of prostate cancer. In: Lepor H, ed. Prostate Diseases. Philadelphia: WB Saunders; 2000:371-380. Lepor H. A review of surgical techniques for radical prostatectomy. Rev Urol. 2005;7(suppl 2): 511-517. Shekarriz B, Upadhyay J, Wood P. Intraoperative, perioperative, and long-term complications of radical prostatectomy. Urol Clin North Am. 2001;28:639-653. 2. 3. 4. 5. 6. 7. 8. 9. 11. 12. 14. 15. 16. 17. 18. 19. 20. Walsh PC, Lepor H, Eggleston JC. Radical prostatectomy with preservation of sexual function: anatomical and pathological considerations. Prostate 1983;4:473-485. Zippe CD, Jhaveri FM, Klein EA, et al. Role of Viagra after radical prostatectomy. Urology. 2000;55:241-245. Baniel J, Israilov S, Segenreich E, et al. Comparative evaluation of treatments for erectile dysfunction in patients with prostate cancer after radical retropubic prostatectomy. BJU Int. 2001; 88:58-62. Cortesi N, Ferrari P, Zambarda E, et al. Diagnosis of bilateral abdominal cryptorchidism by laparoscopy. Endoscopy. 1976;8:33-34. Schuessler WW, Vancaillie TG, Reich H, et al. Transperitoneal endosurgical lymphadenectomy in patients with localized prostate cancer. J Urol. 1991;145:988-991. Partin AW, Kattan MV, Subing ENP, et al. Combination of prostate specific antigens, clinical stage and Gleason score to predict pathological stage of localized prostate cancer. JAMA. 1997; 277:1445-1451. Clayman RV, Kavoussi LR, Soper NJ, et al. Laparoscopic nephrectomy: initial case report. J Urol. 1991;146:278-282. Stifelman MD, Hull D, Sosa RE, et al. Hand assisted laparoscopic nephrectomy: a comparison with the open approach. J Urol. 2001;166: 444-448. Dunn MD, Portis AJ, Shalhav AL, et al. Laparoscopic versus open radical nephrectomy: a 9 year experience. J Urol. 2000;164:1153-1159. Ramani AP, Desai MM, Steinberg AP, et al. Complications of laparoscopic partial nephrectomy in 200 cases. J Urol. 2005;173:42-47. Ruiz L, Salomon L, Hoznek A, et al. Comparison of early oncologic results of laparoscopic radical prostatectomy by extraperitoneal versus transperitoneal approach. Eur Urol. 2004;46:50-54. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 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Nerve sparing radical prostatectomy: effects of hemostatic energy sources and the recovery of cavernous Main Points • The arguments supporting laparoscopic radical prostatectomy are tenuous; the “minimally invasive” advantages of laparoscopic radical prostatectomy, with or without robotic assistance, must ultimately be proved with an evidence-based approach. • The cumulative data suggest that laparoscopic radical prostatectomy with or without robotic assistance has higher positive margin rates compared with open radical prostatectomy in pT2 disease. • Among expert surgeons, laparoscopic radical prostatectomy has a slightly higher intraoperative complication rate compared with open radical prostatectomy. • Overall, the continence rates achieved by expert surgeons after open and laparoscopic radical prostatectomy are uniformly excellent. • Regarding potency, at present, any claims of superior outcomes with either open or laparoscopic radical prostatectomy cannot be justified. • All of the cost comparisons reported to date have confirmed that laparoscopic radical prostatectomy with or without robotic assistance is more costly than open radical prostatectomy. • There seem to be no clinically significant differences between transfusion rates among expert surgeons performing open versus laparoscopic radical prostatectomy; likewise, when pathways are designed to facilitate early discharge from the hospital, there is no significant difference in length of stay between the 2 types of procedure. • In terms of postoperative pain, a recent study showed no advantage of the laparoscopic approach over open radical prostatectomy. 126 VOL. 7 NO. 3 2005 REVIEWS IN UROLOGY Open vs Laparoscopic Radical Prostatectomy 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. nerve function in a canine model. 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