- Email: [email protected]
Contemporary evaluation of operative parameters and complications related to open radical retropubic prostatectomy
ADULT UROLOGY
CONTEMPORARY EVALUATION OF OPERATIVE PARAMETERS AND COMPLICATIONS RELATED TO OPEN RADICAL RETROPUBIC PROSTATECTOMY HERBERT LEPOR
AND
LEDIA KACI
ABSTRACT Objectives. To determine the impact of recent advances in surgical technique, management, and early detection on outcome after open radical retropubic prostatectomy. Methods. Between October 2000 and August 2002, 500 men with clinically localized prostate cancer underwent radical retropubic prostatectomy by a single surgeon (H.L.). One of the unique aspects of this prospective outcomes analysis was that both data acquisition and entry were conducted totally independent of the primary surgeon. Results. The mean operative and prostatectomy time was 142.9 and 65.2 minutes, respectively. A single ureteral injury was the only intraoperative complication. The overall incidence of pulmonary embolus and/or deep vein thrombosis was 0.4%. The overall risk of allogeneic transfusion was 4.6%. The mean length of hospital stay was 2.11 ⫾ 0.04 days. Of the catheters, 83.6% were removed by postoperative day 8. The positive surgical margin rate was 8%. Conclusions. In the hands of experienced surgeons, outcomes after open radical prostatectomy are excellent. Laparoscopic and robotic prostatectomy must be compared with concurrent experiences with open radical prostatectomy. UROLOGY 62: 702–706, 2003. © 2003 Elsevier Inc.
S
everal urologic surgeons have recently reported their complication rates and short-term outcomes associated with radical prostatectomy.1–3 Most surgical procedures included in these reports were performed between the early 1980s and late 1990s. During this interval, significant stage migration occurred because of prostate-specific antigen (PSA) screening, which has had a favorable impact on surgical margin status and disease recurrence rates.4 During the past decade, increasing individual surgical case volumes, along with several important modifications in surgical technique and management, have had a favorable impact on complication rates and short-term outcomes after radical prostatectomy. Some of the major modifications we have adopted during the past decade include limiting pelvic lymph node dissecH. Lepor is co-owner of MedReviews LLC, New York, New York. From the Department of Urology, New York University School of Medicine, New York, New York Reprint requests: Herbert Lepor, M.D., Department of Urology, New York University School of Medicine, 150 East 32nd Street, New York, NY 10016 Submitted: March 24, 2003, accepted (with revisions): May 9, 2003
702
© 2003 ELSEVIER INC. ALL RIGHTS RESERVED
tion to cases with Gleason scores 7 or greater3; more aggressive preoperative cardiac assessment5; administration of recombinant erythropoietin as our preferred preoperative blood management strategy6,7; more efficient control of the dorsal venous complex8; using an algorithm to determine prospectively when to excise a neurovascular bundle9; intraoperative biopsy of the apical soft-tissue margin10; and early removal of the urinary catheter.11,12 Thus, it is timely that we update our open radical retropubic prostatectomy experience by reporting on 500 consecutive cases performed by a single surgeon (H.L.) between October 2000 and August 2002. MATERIAL AND METHODS Between October 2000 and August 2002, 500 prostatectomies were performed by a single surgeon (H.L.) at the New York University Medical Center. Anatomic radical prostatectomy was performed using our previously described technique.8 Properitoneal inguinal herniorrhaphy was performed using the technique described by Schlegel and Walsh.13 Umbilical hernias were also repaired by extending the abdominal incision in a curvilinear manner infraumbilically and incorporating the fascial defect in the lower midline closure. Limited 0090-4295/03/$30.00 doi:10.1016/S0090-4295(03)00515-6
pelvic lymphadenectomy was performed for Gleason score 7 or greater cancer. The overwhelming majority of men underwent an intraoperative biopsy of the apical soft-tissue margin, as previously described.10 Beginning October 2000, intraoperative, postoperative (in hospital), and perioperative (date of discharge through postoperative day [POD] 30) outcomes were prospectively recorded in real time into individual patient data booklets. The database was maintained by a data manager (L.K.). The status of the neurovascular bundles, secondary operative procedures, intraoperative complications, anesthesia time (intubation to extubation), operative time (skin incision to placement of surgical dressing), and prostatectomy time (incision of endopelvic fascia to tying of anastomotic sutures) were recorded by the urology resident immediately after completion of the surgical procedure. Postoperative complications, reoperations, transfusions, and length of stay were recorded by the urology resident immediately before discharge. On POD 30, a urology nurse specialist spoke with all 500 patients by telephone interview specifically to inquire whether patients experienced any of 15 complications and whether the complication resulted in hospital readmission. The level of extravasation and timing of urinary catheter removal were recorded at the time of the cystogram by the urology nurse specialist. The data manager entered the pathologic findings of the intraoperative biopsies and surgical specimen from the pathology report.
RESULTS The baseline characteristics of the 500 consecutive men undergoing open radical retropubic prostatectomy are shown in Table I. Eighty-one percent and 16.6% of the men underwent a bilateral or unilateral nerve-sparing procedure, respectively. Only 2.4% of men underwent bilateral wide excision of the neurovascular bundles. Pelvic lymphadenectomy was performed in 25.8% of cases. Properitoneal inguinal herniorrhaphy and umbilical herniorrhaphy was performed in 10.6% and 1.4% of cases, respectively. A single circumcision, excision of a superficial bladder tumor, bladder stone removal, hydrocelectomy, and intra-abdominal orchiectomy were also performed. The prostatectomy and surgical times were recorded prospectively. The mean prostatectomy time was 63.8 ⫾ 2.6 minutes. The mean surgical time for all cases was 142.9 ⫾ 1.3 minutes. The mean operative time for cases limited to radical retropubic prostatectomy only was 119 ⫾ 1.1 minutes. The intraoperative, postoperative, and perioperative complications are reported in Table II. No deaths occurred. The only intraoperative complication was a ureteral injury. Ureteral reimplantation was performed in this case without sequelae on POD 7. All patients with baseline hematocrits of 48% or less were encouraged to receive preoperative recombinant erythropoietin. The overall risk of an allogeneic transfusion was 4.6%. The risk of allogeneic blood transfusion was significantly lower in UROLOGY 62 (4), 2003
TABLE I. Baseline characteristics of study population Characteristic Age (yr) Mean ⫾ SEM Range Serum PSA (ng/mL) Mean ⫾ SEM Range Clinical stage (n) T1a T1b T1c T2a T2b T2c T3 Gleason score 2–4 5–6 7 8–10 Serum PSA (ng/mL) 0–2.49 2.50–3.99 4.0–7.50 7.51–9.99 ⱖ10.0 Age group (yr) ⬍40 41–50 51–60 61–70 ⬎70
58.8 ⫾ 0.3 41–74 6.5 ⫾ 0.2 0.2–46.9 3 0 423 47 18 7 1
(0.6) (0) (84.8) (9.4) (3.6) (1.6) (0.2)
2 373 110 15
(0.4) (74.6) (22.0) (3.0)
35 51 302 55 57
(7.0) (10.2) (60.4) (11.0) (11.4)
0 43 213 216 28
(0) (8.6) (42.6) (43.2) (5.6)
KEY: PSA ⫽ prostate-specific antigen. Numbers in parentheses are percentages.
men who had received recombinant erythropoietin or preoperative autologous blood donation compared with no blood management. The mean discharge hematocrit was 34.0%. The discharge hematocrit was significantly greater in men receiving erythropoietin (34.8 ⫾ 0.2) compared with autologous blood donation (30.8 ⫾ 0.54) or no management (30.8 ⫾ 0.66). The mean ⫾ SEM length of hospital stay was 2.11 ⫾ 0.04 days; 90.2% of men were discharged by POD 2. Of the 500 men, 480 (96%) underwent cystography before removal of the Foley catheter between POD 3 and 8. In 83.6% of cases, the cystogram demonstrated a totally watertight anastomosis, and the catheter was removed. Overall, the cancer was pathologically organ confined in 80.8% of cases. The surgical margins were positive in 12% of cases based on the surgical specimen. In 22 of cases (4%), the apex of the surgical specimen was positive for cancer and the corresponding biopsy of the true apical soft-tissue margin showed no cancer. These cases were desig703
TABLE II. Complications and transfusion rates n Complications Intraoperative Death Rectal injury Ureteral injury Obturator injury Vascular injury Postoperative (in hospital) Bleeding requiring reoperation Pneumonia Prolonged ileus Myocardial infarction Wound seroma/infection Pulmonary embolus Deep vein thrombosis Cerebrovascular accident Death Perioperative (discharge—POD 30) Acute urinary retention Clot urinary retention Wound seroma/infection Myocardial infarction Deep vein thrombosis Clostridium difficile infection Pneumonia Death Preoperative blood management* Erythropoietin Autologous blood donation None
%
0 0 1 0 0
0 0 0.2 0 0
3 2 2 1 1 0 0 0 0
0.6 0.4 0.4 0.2 0.2 0 0 0 0
27 6 5 2 2 1 0 0
5.4 1.2 1.0 0.4 0.4 0.2 0 0
410 54 36
2.7 1.8 8.4†
KEY: POD ⫽ postoperative day. * Percentages given as percentage of allogeneic transfusion. † P ⬍0.05 between erythropoietin vs. no blood management and autologous blood donation vs. no blood management.
nated as having positive/negative margins. Because we interpreted these cases as having negative margins, our overall positive margin rate was 8%. The percentage of tumors that were pathologically Gleason score 2 to 4, 5 to 6, 7, and 8 to 10 was 0%, 61.0%, 34.2%, and 4.8%, respectively. COMMENT One of the unique strengths of our prospective series was that all data points were recorded in real time by our urology residents and urology nurse specialists into individual patient data booklets, and a data manager (L.K.) ensured compliance with data recording and entry. At no time did the operating surgeon record or interpret any data entries. All 500 patients were interviewed on POD 30 by a urology nurse specialist to ensure that the perioperative complications were not underestimated. This report focused on 52 data points per patient. Overall, we had a total of 6000 data points 704
among the 500 patients. All 6000 data points were assessable and entered into our database. All men were examined preoperatively for inguinal hernias; 10.6% of men with clinically palpable inguinal hernias underwent properitoneal herniorrhaphy, as described by Schlegel and Walsh.13 Lodding et al.14 reported that 13.6% of men followed up for a mean of 3 years after radical prostatectomy were found to have inguinal hernias. This high incidence of postprostatectomy inguinal hernias was attributed to subclinical hernias that became clinically evident owing to anastomotic strictures or weakening of the abdominal wall musculature secondary to the lower abdominal incision. Our rate of pre-existing clinical hernias is comparable to the rate of inguinal herniorrhaphies identified by Lodding et al.14 postoperatively. We recommend that all men undergoing radical prostatectomy should be screened preoperatively for an inguinal hernia that, if found, should be corrected at the radical prostatectomy. The primary surgical goal is to perform an anatomic radical prostatectomy with good cancer control and preservation of continence and erectile function. We believe that a shorter surgical time minimizes blood loss, decreases the risk of postoperative ileus and deep vein thrombosis, and shortens the hospital stay. It is important to define the operative times precisely, especially if attempting to compare different techniques for radical prostatectomy. Our mean surgical time for all cases was 143 minutes, which represents the time from incision to placement of the surgical dressing. The mean operative time for the radical retropubic prostatectomies performed without secondary procedures such as pelvic lymphadenectomy and herniorrhaphy was only 119 minutes. Rassweiler et al.15 and Guillonneau and Vallancien16 reported a mean operative time for laparoscopic radical prostatectomy of 271 and 239 minutes, respectively. Menon et al.17 reported a mean operative time of 274 minutes for robotic radical prostatectomy. Menon et al.17 defined the mean operative time from the start of dissection to closure. Our mean prostatectomy time, which corresponds to the operative time of Menon et al., was only 64 minutes. The operative or prostatectomy time after laparoscopic and robotic radical prostatectomy exceeded open radical retropubic prostatectomy by fourfold. Our overall complication rate was extremely low despite meticulous effort to report every complication prospectively and the 100% completeness of our database. The only intraoperative complication was that of a ureteral injury in a man from Kenya with unrecognized schistosomiasis. The ureter was reimplanted without sequelae. The total postoperative complication rate was 1.8%. None of the intraoperative or postoperative complications UROLOGY 62 (4), 2003
was associated with long-term consequences. We believe our complication rate represents the lowest reported to date for any radical prostatectomy series.1–3,15–17 To track our perioperative complications accurately, 100% of the patients were spoken with by telephone interview by our nurse clinician. The nurses reviewed a checklist of 15 possible delayed complications and inquired if other complications had occurred that were not captured by the questionnaire. Overall, 5.4% of the men developed acute urinary retention. Most of these cases of acute urinary retention occurred in men who had their urinary catheters removed on POD 3 or 4. If one excludes acute urinary retention, the perioperative complication rate was 3.2%. We have previously reported on the safety and effectiveness of recombinant erythropoietin as a blood management strategy.6,7 We recommend preoperative subcutaneous injection of recombinant erythropoietin for all men with baseline hematocrits of 48% or less. The advantages of recombinant erythropoietin relative to autologous blood donation are lower cost, avoidance of postoperative anemia, avoidance of transfusing autologous blood, convenience, and a higher discharge hematocrit. Our overall transfusion rate was 4.6%. No statistically significant difference was found in the transfusion rates between men receiving preoperative erythropoietin and those receiving autologous blood donation. Men receiving preoperative erythropoietin or autologous blood donation had a significantly lower risk of allogeneic blood exposure compared with no blood management intervention. On the basis of our experience, we believe it is prudent to offer men some form of intervention to lower the risk of exposure to allogeneic blood. We believe that the significantly greater discharge hematocrit in those men receiving recombinant erythropoietin compared with those men undergoing preoperative autologous blood donation or no blood management is clinically relevant and that recombinant erythropoietin should be the preferred blood management option. Enthusiasm is increasing for removing the urinary catheter as early as possible. We have previously reported that removal of the urinary catheter on POD 7 in cases with no extravasation on cystography is safe and prudent.11 In our first experience with “early” catheter removal, 71% of the catheters were removed on POD 7.11 We subsequently investigated performing cystograms on POD 3 or 4 with removal of the catheter in the absence of extravasation.12 Although the probability of a watertight anastomosis was equivalent on POD 3 or 4 versus POD 7 (76.8% versus 75%), a greater percentage of men subsequently developed acute urinary retention, and 2 cases required reoperation because of UROLOGY 62 (4), 2003
removal of the catheter on POD 3 or 4. Beginning in October 2000, we performed cystography on POD 8 and administered 7 days of tamsulosin 0.4 mg beginning on POD 4. In the present series, 83.6% of catheters were removed by POD 8. The acute urinary retention rate in the present series decreased to 5.7%. We attribute the lower acute urinary retention rate to the routine administration of tamsulosin before removal of the catheter beginning on POD 5.18 Of the 500 men, 90.2% in the present series were discharged by POD 2. Because most of our surgical patients travel more than 2 hours to the New York University Medical Center, patients and their families resist discharge on POD 1, even though they are tolerating a regular diet, the surgical drains have been removed, and they require only oral analgesics. We do not feel compelled to have our patients discharged to a local hotel or insist that they leave the hospital to decrease our length of stay further. The mean length of hospital stay for laparoscopic radical prostatectomy reported by Rassweiler et al.15 and Guillonneau and Vallancien16 was 10 days and 6 days, respectively. On the basis of published reports, our length of hospital stay is markedly shorter than that after laparoscopic procedures. Overall, 80.6% of the cancers were pathologically organ confined to the prostate. This is comparable to a pathologically organ-confined rate of 77.2% in our prior series.3 Ninety-two percent of men had negative surgical margins. This is a significantly lower positive margin rate than reported in our prior series.3 We attribute our lower risk of positive margins to routine biopsy of the apical soft-tissue margin,10 better surgical technique,8 the adoption of an algorithm to guide decisions for preserving or excising the neurovascular bundles, and clinical stage migration owing to increasing proportions of T1c disease.9 Our positive margin rate is among the lowest reported to date.19 The very low positive margin rate was achieved while performing bilateral or unilateral nerve-sparing procedures in 81% and 16.6% of cases, respectively. Several advocates of laparoscopic or robotic radical prostatectomy have argued the advantages of these approaches over open radical retropubic prostatectomy.15–17 It is difficult to compare the advantages of different surgical approaches to radical prostatectomy performed at different institutions because the method for outcome assessments has not been standardized. In addition, different outcomes may reflect artificial advantages owing to management strategies of the surgeon that are not inherent to the procedure (ie, criteria for discharge). 705
The most important outcomes after radical prostatectomy are the complication, reoperation, positive surgical margin, and biochemical recurrence rates. No large laparoscopic or robotic series of radical prostatectomy has been reported with rates of intraoperative complications, early reintervention, and positive surgical margins as low as 0.2%, 0.6%, and 8%, respectively, which we report in our present series.15–17 No long-term data are available to determine whether laparoscopic or robotic radical prostatectomy achieves comparable disease control. The transfusion rate for laparoscopic radical prostatectomy reported by Guillonneau and Vallancien16 and Rassweiler et al.15 was 10% and 31%, respectively. Claims that the laparoscopic approach is associated with less bleeding and a lower transfusion rate are not supported by the published data. It is the relatively high incidence of acute urinary retention and not a greater propensity to achieve a watertight anastomosis that limits removal of the urinary catheter before 7 days after both open12 and laparoscopic20 radical prostatectomy. The operative time, length of hospital stay, and time to return to activities are of limited clinical relevance. The laparoscopic and robotic radical prostatectomy operative times are much longer than the time for open radical prostatectomy.15–17 The length of hospital stay is most dependent on individual criteria and patient expectation, so that comparisons between series are of limited relevance. We encourage our patients to return to unrestricted physical activities, including heavy lifting and sports, within 3 weeks of radical prostatectomy.21 Thus, no objective data are available to support a quicker recovery after robotic or laparoscopic radical prostatectomy. CONCLUSIONS In the hands of experienced surgeons, the intraoperative, postoperative, and perioperative outcomes after open radical prostatectomy are excellent. In 2002, there was no compelling advantage of laparoscopic or robotic radical prostatectomy over open radical prostatectomy. Until compelling advantages of laparoscopic or robotic radical prostatectomy are demonstrated, the widespread rush to embrace these new technologies should be discouraged owing to the morbidity associated with the learning curve.15–17 REFERENCES 1. Lerner SE, Blute ML, Lieber NM, et al: Morbidity of contemporary radical retropubic prostatectomy for localized prostate cancer. Oncology 9: 379 –389, 1995.
706
2. Catalona WJ, Carvalhal GF, Mager DE, et al: Potency, continence and complication rates in 1870 consecutive radical retropubic prostatectomies. J Urol 162: 433–438, 1999. 3. Lepor H, Nieder AM, and Ferrandino MN: The intraoperative and postoperative complications following radical retropubic prostatectomy in a consecutive series of 1,000 cases. J Urol 166: 1729 –1733, 2001. 4. Han M, Partin AW, Piantadosi S, et al: Era specific biochemical recurrence-free survival following radical prostatectomy for clinically localized prostate cancer. J Urol 166: 416 – 419, 2001. 5. Rosenblum N, and Lepor H: Radical retropubic prostatectomy: preoperative management. Urol Clin North Am 28: 499 –507, 2001. 6. Rosenblum N, Levine MA, Handler T, et al: The role of preoperative epoetin alpha in men undergoing radical retropubic prostatectomy. J Urol 163: 829 –833, 2000. 7. Nieder AM, Rosenblum N, and Lepor H: Comparison of two different doses of preoperative recombinant erythropoietin in men undergoing radical retropubic prostatectomy. Urology 57: 737–741, 2001. 8. Lepor H: Radical retropubic prostatectomy. Urol Clin North Am 28: 509 –519, 2001. 9. Shah O, Robbins DA, Melamed J, et al: The NYU nerve sparing algorithm decreases the rate of positive surgical margins following radical retropubic prostatectomy. J Urol 169: 2147–2152, 2003. 10. Shah O, Melamed J, and Lepor H: Analysis of apical soft tissue margins during radical retropubic prostatectomy. J Urol 165(6 Pt 1): 1943–1948, 2001. 11. Lepor H, Nieder AM, and Fraiman MC: Early removal of urinary catheter after radical retropubic prostatectomy is both feasible and desirable. Urology 58: 425–429, 2001. 12. Patel R, and Lepor H: Removal of the urinary catheter on postoperative days 3 and 4 following radical retropubic prostatectomy. Urology 61: 156 –160, 2003. 13. Schlegel PN, and Walsh PC: Simultaneous preperitoneal hernia repair during radical pelvic surgery. J Urol 137: 1180 –1183, 1987. 14. Lodding P, Bergdahl C, Nyberg M, et al: Inguinal hernia after radical retropubic prostatectomy for prostate cancer: a study of incidence and risk factors in comparison to no operation and lymphadenectomy. J Urol 166: 964 –967, 2001. 15. Rassweiler J, Sentker L, Seemann O, et al: Laparoscopic radical prostatectomy with the Heilbronn technique: an analysis of the first 180 cases. J Urol 166: 2101–2108, 2001. 16. Guillonneau B, and Vallancien G: Laparoscopic radical prostatectomy: the Montsoursis experience. J Urol 163: 418 – 422, 2000. 17. Menon M, Shrivastava A, Tewari A, et al: Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. J Urol 168: 945–949, 2002. 18. Patel R, Fiske J, and Lepor H: Tamsulosin reduces the incidence of acute urinary retention following early removal of the urinary catheter following radical retropubic prostatectomy. Urology (in press). 19. Epstein JI: Pathologic assessment of the surgical specimen. Urol Clin North Am 28: 567–594, 2001. 20. Nadu A, Salomon L, Hoznek A, et al: Early removal of the catheter after laparoscopic radical prostatectomy. J Urol 166: 1662–1664, 2001. 21. Lepor H: Radical prostatectomy: status and opportunities for improving outcomes. Cancer Invest (in press).
UROLOGY 62 (4), 2003
CONTEMPORARY EVALUATION OF OPERATIVE PARAMETERS AND COMPLICATIONS RELATED TO OPEN RADICAL RETROPUBIC PROSTATECTOMY HERBERT LEPOR
AND
LEDIA KACI
ABSTRACT Objectives. To determine the impact of recent advances in surgical technique, management, and early detection on outcome after open radical retropubic prostatectomy. Methods. Between October 2000 and August 2002, 500 men with clinically localized prostate cancer underwent radical retropubic prostatectomy by a single surgeon (H.L.). One of the unique aspects of this prospective outcomes analysis was that both data acquisition and entry were conducted totally independent of the primary surgeon. Results. The mean operative and prostatectomy time was 142.9 and 65.2 minutes, respectively. A single ureteral injury was the only intraoperative complication. The overall incidence of pulmonary embolus and/or deep vein thrombosis was 0.4%. The overall risk of allogeneic transfusion was 4.6%. The mean length of hospital stay was 2.11 ⫾ 0.04 days. Of the catheters, 83.6% were removed by postoperative day 8. The positive surgical margin rate was 8%. Conclusions. In the hands of experienced surgeons, outcomes after open radical prostatectomy are excellent. Laparoscopic and robotic prostatectomy must be compared with concurrent experiences with open radical prostatectomy. UROLOGY 62: 702–706, 2003. © 2003 Elsevier Inc.
S
everal urologic surgeons have recently reported their complication rates and short-term outcomes associated with radical prostatectomy.1–3 Most surgical procedures included in these reports were performed between the early 1980s and late 1990s. During this interval, significant stage migration occurred because of prostate-specific antigen (PSA) screening, which has had a favorable impact on surgical margin status and disease recurrence rates.4 During the past decade, increasing individual surgical case volumes, along with several important modifications in surgical technique and management, have had a favorable impact on complication rates and short-term outcomes after radical prostatectomy. Some of the major modifications we have adopted during the past decade include limiting pelvic lymph node dissecH. Lepor is co-owner of MedReviews LLC, New York, New York. From the Department of Urology, New York University School of Medicine, New York, New York Reprint requests: Herbert Lepor, M.D., Department of Urology, New York University School of Medicine, 150 East 32nd Street, New York, NY 10016 Submitted: March 24, 2003, accepted (with revisions): May 9, 2003
702
© 2003 ELSEVIER INC. ALL RIGHTS RESERVED
tion to cases with Gleason scores 7 or greater3; more aggressive preoperative cardiac assessment5; administration of recombinant erythropoietin as our preferred preoperative blood management strategy6,7; more efficient control of the dorsal venous complex8; using an algorithm to determine prospectively when to excise a neurovascular bundle9; intraoperative biopsy of the apical soft-tissue margin10; and early removal of the urinary catheter.11,12 Thus, it is timely that we update our open radical retropubic prostatectomy experience by reporting on 500 consecutive cases performed by a single surgeon (H.L.) between October 2000 and August 2002. MATERIAL AND METHODS Between October 2000 and August 2002, 500 prostatectomies were performed by a single surgeon (H.L.) at the New York University Medical Center. Anatomic radical prostatectomy was performed using our previously described technique.8 Properitoneal inguinal herniorrhaphy was performed using the technique described by Schlegel and Walsh.13 Umbilical hernias were also repaired by extending the abdominal incision in a curvilinear manner infraumbilically and incorporating the fascial defect in the lower midline closure. Limited 0090-4295/03/$30.00 doi:10.1016/S0090-4295(03)00515-6
pelvic lymphadenectomy was performed for Gleason score 7 or greater cancer. The overwhelming majority of men underwent an intraoperative biopsy of the apical soft-tissue margin, as previously described.10 Beginning October 2000, intraoperative, postoperative (in hospital), and perioperative (date of discharge through postoperative day [POD] 30) outcomes were prospectively recorded in real time into individual patient data booklets. The database was maintained by a data manager (L.K.). The status of the neurovascular bundles, secondary operative procedures, intraoperative complications, anesthesia time (intubation to extubation), operative time (skin incision to placement of surgical dressing), and prostatectomy time (incision of endopelvic fascia to tying of anastomotic sutures) were recorded by the urology resident immediately after completion of the surgical procedure. Postoperative complications, reoperations, transfusions, and length of stay were recorded by the urology resident immediately before discharge. On POD 30, a urology nurse specialist spoke with all 500 patients by telephone interview specifically to inquire whether patients experienced any of 15 complications and whether the complication resulted in hospital readmission. The level of extravasation and timing of urinary catheter removal were recorded at the time of the cystogram by the urology nurse specialist. The data manager entered the pathologic findings of the intraoperative biopsies and surgical specimen from the pathology report.
RESULTS The baseline characteristics of the 500 consecutive men undergoing open radical retropubic prostatectomy are shown in Table I. Eighty-one percent and 16.6% of the men underwent a bilateral or unilateral nerve-sparing procedure, respectively. Only 2.4% of men underwent bilateral wide excision of the neurovascular bundles. Pelvic lymphadenectomy was performed in 25.8% of cases. Properitoneal inguinal herniorrhaphy and umbilical herniorrhaphy was performed in 10.6% and 1.4% of cases, respectively. A single circumcision, excision of a superficial bladder tumor, bladder stone removal, hydrocelectomy, and intra-abdominal orchiectomy were also performed. The prostatectomy and surgical times were recorded prospectively. The mean prostatectomy time was 63.8 ⫾ 2.6 minutes. The mean surgical time for all cases was 142.9 ⫾ 1.3 minutes. The mean operative time for cases limited to radical retropubic prostatectomy only was 119 ⫾ 1.1 minutes. The intraoperative, postoperative, and perioperative complications are reported in Table II. No deaths occurred. The only intraoperative complication was a ureteral injury. Ureteral reimplantation was performed in this case without sequelae on POD 7. All patients with baseline hematocrits of 48% or less were encouraged to receive preoperative recombinant erythropoietin. The overall risk of an allogeneic transfusion was 4.6%. The risk of allogeneic blood transfusion was significantly lower in UROLOGY 62 (4), 2003
TABLE I. Baseline characteristics of study population Characteristic Age (yr) Mean ⫾ SEM Range Serum PSA (ng/mL) Mean ⫾ SEM Range Clinical stage (n) T1a T1b T1c T2a T2b T2c T3 Gleason score 2–4 5–6 7 8–10 Serum PSA (ng/mL) 0–2.49 2.50–3.99 4.0–7.50 7.51–9.99 ⱖ10.0 Age group (yr) ⬍40 41–50 51–60 61–70 ⬎70
58.8 ⫾ 0.3 41–74 6.5 ⫾ 0.2 0.2–46.9 3 0 423 47 18 7 1
(0.6) (0) (84.8) (9.4) (3.6) (1.6) (0.2)
2 373 110 15
(0.4) (74.6) (22.0) (3.0)
35 51 302 55 57
(7.0) (10.2) (60.4) (11.0) (11.4)
0 43 213 216 28
(0) (8.6) (42.6) (43.2) (5.6)
KEY: PSA ⫽ prostate-specific antigen. Numbers in parentheses are percentages.
men who had received recombinant erythropoietin or preoperative autologous blood donation compared with no blood management. The mean discharge hematocrit was 34.0%. The discharge hematocrit was significantly greater in men receiving erythropoietin (34.8 ⫾ 0.2) compared with autologous blood donation (30.8 ⫾ 0.54) or no management (30.8 ⫾ 0.66). The mean ⫾ SEM length of hospital stay was 2.11 ⫾ 0.04 days; 90.2% of men were discharged by POD 2. Of the 500 men, 480 (96%) underwent cystography before removal of the Foley catheter between POD 3 and 8. In 83.6% of cases, the cystogram demonstrated a totally watertight anastomosis, and the catheter was removed. Overall, the cancer was pathologically organ confined in 80.8% of cases. The surgical margins were positive in 12% of cases based on the surgical specimen. In 22 of cases (4%), the apex of the surgical specimen was positive for cancer and the corresponding biopsy of the true apical soft-tissue margin showed no cancer. These cases were desig703
TABLE II. Complications and transfusion rates n Complications Intraoperative Death Rectal injury Ureteral injury Obturator injury Vascular injury Postoperative (in hospital) Bleeding requiring reoperation Pneumonia Prolonged ileus Myocardial infarction Wound seroma/infection Pulmonary embolus Deep vein thrombosis Cerebrovascular accident Death Perioperative (discharge—POD 30) Acute urinary retention Clot urinary retention Wound seroma/infection Myocardial infarction Deep vein thrombosis Clostridium difficile infection Pneumonia Death Preoperative blood management* Erythropoietin Autologous blood donation None
%
0 0 1 0 0
0 0 0.2 0 0
3 2 2 1 1 0 0 0 0
0.6 0.4 0.4 0.2 0.2 0 0 0 0
27 6 5 2 2 1 0 0
5.4 1.2 1.0 0.4 0.4 0.2 0 0
410 54 36
2.7 1.8 8.4†
KEY: POD ⫽ postoperative day. * Percentages given as percentage of allogeneic transfusion. † P ⬍0.05 between erythropoietin vs. no blood management and autologous blood donation vs. no blood management.
nated as having positive/negative margins. Because we interpreted these cases as having negative margins, our overall positive margin rate was 8%. The percentage of tumors that were pathologically Gleason score 2 to 4, 5 to 6, 7, and 8 to 10 was 0%, 61.0%, 34.2%, and 4.8%, respectively. COMMENT One of the unique strengths of our prospective series was that all data points were recorded in real time by our urology residents and urology nurse specialists into individual patient data booklets, and a data manager (L.K.) ensured compliance with data recording and entry. At no time did the operating surgeon record or interpret any data entries. All 500 patients were interviewed on POD 30 by a urology nurse specialist to ensure that the perioperative complications were not underestimated. This report focused on 52 data points per patient. Overall, we had a total of 6000 data points 704
among the 500 patients. All 6000 data points were assessable and entered into our database. All men were examined preoperatively for inguinal hernias; 10.6% of men with clinically palpable inguinal hernias underwent properitoneal herniorrhaphy, as described by Schlegel and Walsh.13 Lodding et al.14 reported that 13.6% of men followed up for a mean of 3 years after radical prostatectomy were found to have inguinal hernias. This high incidence of postprostatectomy inguinal hernias was attributed to subclinical hernias that became clinically evident owing to anastomotic strictures or weakening of the abdominal wall musculature secondary to the lower abdominal incision. Our rate of pre-existing clinical hernias is comparable to the rate of inguinal herniorrhaphies identified by Lodding et al.14 postoperatively. We recommend that all men undergoing radical prostatectomy should be screened preoperatively for an inguinal hernia that, if found, should be corrected at the radical prostatectomy. The primary surgical goal is to perform an anatomic radical prostatectomy with good cancer control and preservation of continence and erectile function. We believe that a shorter surgical time minimizes blood loss, decreases the risk of postoperative ileus and deep vein thrombosis, and shortens the hospital stay. It is important to define the operative times precisely, especially if attempting to compare different techniques for radical prostatectomy. Our mean surgical time for all cases was 143 minutes, which represents the time from incision to placement of the surgical dressing. The mean operative time for the radical retropubic prostatectomies performed without secondary procedures such as pelvic lymphadenectomy and herniorrhaphy was only 119 minutes. Rassweiler et al.15 and Guillonneau and Vallancien16 reported a mean operative time for laparoscopic radical prostatectomy of 271 and 239 minutes, respectively. Menon et al.17 reported a mean operative time of 274 minutes for robotic radical prostatectomy. Menon et al.17 defined the mean operative time from the start of dissection to closure. Our mean prostatectomy time, which corresponds to the operative time of Menon et al., was only 64 minutes. The operative or prostatectomy time after laparoscopic and robotic radical prostatectomy exceeded open radical retropubic prostatectomy by fourfold. Our overall complication rate was extremely low despite meticulous effort to report every complication prospectively and the 100% completeness of our database. The only intraoperative complication was that of a ureteral injury in a man from Kenya with unrecognized schistosomiasis. The ureter was reimplanted without sequelae. The total postoperative complication rate was 1.8%. None of the intraoperative or postoperative complications UROLOGY 62 (4), 2003
was associated with long-term consequences. We believe our complication rate represents the lowest reported to date for any radical prostatectomy series.1–3,15–17 To track our perioperative complications accurately, 100% of the patients were spoken with by telephone interview by our nurse clinician. The nurses reviewed a checklist of 15 possible delayed complications and inquired if other complications had occurred that were not captured by the questionnaire. Overall, 5.4% of the men developed acute urinary retention. Most of these cases of acute urinary retention occurred in men who had their urinary catheters removed on POD 3 or 4. If one excludes acute urinary retention, the perioperative complication rate was 3.2%. We have previously reported on the safety and effectiveness of recombinant erythropoietin as a blood management strategy.6,7 We recommend preoperative subcutaneous injection of recombinant erythropoietin for all men with baseline hematocrits of 48% or less. The advantages of recombinant erythropoietin relative to autologous blood donation are lower cost, avoidance of postoperative anemia, avoidance of transfusing autologous blood, convenience, and a higher discharge hematocrit. Our overall transfusion rate was 4.6%. No statistically significant difference was found in the transfusion rates between men receiving preoperative erythropoietin and those receiving autologous blood donation. Men receiving preoperative erythropoietin or autologous blood donation had a significantly lower risk of allogeneic blood exposure compared with no blood management intervention. On the basis of our experience, we believe it is prudent to offer men some form of intervention to lower the risk of exposure to allogeneic blood. We believe that the significantly greater discharge hematocrit in those men receiving recombinant erythropoietin compared with those men undergoing preoperative autologous blood donation or no blood management is clinically relevant and that recombinant erythropoietin should be the preferred blood management option. Enthusiasm is increasing for removing the urinary catheter as early as possible. We have previously reported that removal of the urinary catheter on POD 7 in cases with no extravasation on cystography is safe and prudent.11 In our first experience with “early” catheter removal, 71% of the catheters were removed on POD 7.11 We subsequently investigated performing cystograms on POD 3 or 4 with removal of the catheter in the absence of extravasation.12 Although the probability of a watertight anastomosis was equivalent on POD 3 or 4 versus POD 7 (76.8% versus 75%), a greater percentage of men subsequently developed acute urinary retention, and 2 cases required reoperation because of UROLOGY 62 (4), 2003
removal of the catheter on POD 3 or 4. Beginning in October 2000, we performed cystography on POD 8 and administered 7 days of tamsulosin 0.4 mg beginning on POD 4. In the present series, 83.6% of catheters were removed by POD 8. The acute urinary retention rate in the present series decreased to 5.7%. We attribute the lower acute urinary retention rate to the routine administration of tamsulosin before removal of the catheter beginning on POD 5.18 Of the 500 men, 90.2% in the present series were discharged by POD 2. Because most of our surgical patients travel more than 2 hours to the New York University Medical Center, patients and their families resist discharge on POD 1, even though they are tolerating a regular diet, the surgical drains have been removed, and they require only oral analgesics. We do not feel compelled to have our patients discharged to a local hotel or insist that they leave the hospital to decrease our length of stay further. The mean length of hospital stay for laparoscopic radical prostatectomy reported by Rassweiler et al.15 and Guillonneau and Vallancien16 was 10 days and 6 days, respectively. On the basis of published reports, our length of hospital stay is markedly shorter than that after laparoscopic procedures. Overall, 80.6% of the cancers were pathologically organ confined to the prostate. This is comparable to a pathologically organ-confined rate of 77.2% in our prior series.3 Ninety-two percent of men had negative surgical margins. This is a significantly lower positive margin rate than reported in our prior series.3 We attribute our lower risk of positive margins to routine biopsy of the apical soft-tissue margin,10 better surgical technique,8 the adoption of an algorithm to guide decisions for preserving or excising the neurovascular bundles, and clinical stage migration owing to increasing proportions of T1c disease.9 Our positive margin rate is among the lowest reported to date.19 The very low positive margin rate was achieved while performing bilateral or unilateral nerve-sparing procedures in 81% and 16.6% of cases, respectively. Several advocates of laparoscopic or robotic radical prostatectomy have argued the advantages of these approaches over open radical retropubic prostatectomy.15–17 It is difficult to compare the advantages of different surgical approaches to radical prostatectomy performed at different institutions because the method for outcome assessments has not been standardized. In addition, different outcomes may reflect artificial advantages owing to management strategies of the surgeon that are not inherent to the procedure (ie, criteria for discharge). 705
The most important outcomes after radical prostatectomy are the complication, reoperation, positive surgical margin, and biochemical recurrence rates. No large laparoscopic or robotic series of radical prostatectomy has been reported with rates of intraoperative complications, early reintervention, and positive surgical margins as low as 0.2%, 0.6%, and 8%, respectively, which we report in our present series.15–17 No long-term data are available to determine whether laparoscopic or robotic radical prostatectomy achieves comparable disease control. The transfusion rate for laparoscopic radical prostatectomy reported by Guillonneau and Vallancien16 and Rassweiler et al.15 was 10% and 31%, respectively. Claims that the laparoscopic approach is associated with less bleeding and a lower transfusion rate are not supported by the published data. It is the relatively high incidence of acute urinary retention and not a greater propensity to achieve a watertight anastomosis that limits removal of the urinary catheter before 7 days after both open12 and laparoscopic20 radical prostatectomy. The operative time, length of hospital stay, and time to return to activities are of limited clinical relevance. The laparoscopic and robotic radical prostatectomy operative times are much longer than the time for open radical prostatectomy.15–17 The length of hospital stay is most dependent on individual criteria and patient expectation, so that comparisons between series are of limited relevance. We encourage our patients to return to unrestricted physical activities, including heavy lifting and sports, within 3 weeks of radical prostatectomy.21 Thus, no objective data are available to support a quicker recovery after robotic or laparoscopic radical prostatectomy. CONCLUSIONS In the hands of experienced surgeons, the intraoperative, postoperative, and perioperative outcomes after open radical prostatectomy are excellent. In 2002, there was no compelling advantage of laparoscopic or robotic radical prostatectomy over open radical prostatectomy. Until compelling advantages of laparoscopic or robotic radical prostatectomy are demonstrated, the widespread rush to embrace these new technologies should be discouraged owing to the morbidity associated with the learning curve.15–17 REFERENCES 1. Lerner SE, Blute ML, Lieber NM, et al: Morbidity of contemporary radical retropubic prostatectomy for localized prostate cancer. Oncology 9: 379 –389, 1995.
706
2. Catalona WJ, Carvalhal GF, Mager DE, et al: Potency, continence and complication rates in 1870 consecutive radical retropubic prostatectomies. J Urol 162: 433–438, 1999. 3. Lepor H, Nieder AM, and Ferrandino MN: The intraoperative and postoperative complications following radical retropubic prostatectomy in a consecutive series of 1,000 cases. J Urol 166: 1729 –1733, 2001. 4. Han M, Partin AW, Piantadosi S, et al: Era specific biochemical recurrence-free survival following radical prostatectomy for clinically localized prostate cancer. J Urol 166: 416 – 419, 2001. 5. Rosenblum N, and Lepor H: Radical retropubic prostatectomy: preoperative management. Urol Clin North Am 28: 499 –507, 2001. 6. Rosenblum N, Levine MA, Handler T, et al: The role of preoperative epoetin alpha in men undergoing radical retropubic prostatectomy. J Urol 163: 829 –833, 2000. 7. Nieder AM, Rosenblum N, and Lepor H: Comparison of two different doses of preoperative recombinant erythropoietin in men undergoing radical retropubic prostatectomy. Urology 57: 737–741, 2001. 8. Lepor H: Radical retropubic prostatectomy. Urol Clin North Am 28: 509 –519, 2001. 9. Shah O, Robbins DA, Melamed J, et al: The NYU nerve sparing algorithm decreases the rate of positive surgical margins following radical retropubic prostatectomy. J Urol 169: 2147–2152, 2003. 10. Shah O, Melamed J, and Lepor H: Analysis of apical soft tissue margins during radical retropubic prostatectomy. J Urol 165(6 Pt 1): 1943–1948, 2001. 11. Lepor H, Nieder AM, and Fraiman MC: Early removal of urinary catheter after radical retropubic prostatectomy is both feasible and desirable. Urology 58: 425–429, 2001. 12. Patel R, and Lepor H: Removal of the urinary catheter on postoperative days 3 and 4 following radical retropubic prostatectomy. Urology 61: 156 –160, 2003. 13. Schlegel PN, and Walsh PC: Simultaneous preperitoneal hernia repair during radical pelvic surgery. J Urol 137: 1180 –1183, 1987. 14. Lodding P, Bergdahl C, Nyberg M, et al: Inguinal hernia after radical retropubic prostatectomy for prostate cancer: a study of incidence and risk factors in comparison to no operation and lymphadenectomy. J Urol 166: 964 –967, 2001. 15. Rassweiler J, Sentker L, Seemann O, et al: Laparoscopic radical prostatectomy with the Heilbronn technique: an analysis of the first 180 cases. J Urol 166: 2101–2108, 2001. 16. Guillonneau B, and Vallancien G: Laparoscopic radical prostatectomy: the Montsoursis experience. J Urol 163: 418 – 422, 2000. 17. Menon M, Shrivastava A, Tewari A, et al: Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. J Urol 168: 945–949, 2002. 18. Patel R, Fiske J, and Lepor H: Tamsulosin reduces the incidence of acute urinary retention following early removal of the urinary catheter following radical retropubic prostatectomy. Urology (in press). 19. Epstein JI: Pathologic assessment of the surgical specimen. Urol Clin North Am 28: 567–594, 2001. 20. Nadu A, Salomon L, Hoznek A, et al: Early removal of the catheter after laparoscopic radical prostatectomy. J Urol 166: 1662–1664, 2001. 21. Lepor H: Radical prostatectomy: status and opportunities for improving outcomes. Cancer Invest (in press).
UROLOGY 62 (4), 2003