Comprehensive Standardized Report of Complications of Retropubic and Laparoscopic Radical Prostatectomy

Transcription

1 EUROPEAN UROLOGY 57 (2010) available at journal homepage: Platinum Priority Prostate Cancer Editorial by Markus Graefen on pp of this issue Comprehensive Standardized Report of Complications of Retropubic and Laparoscopic Radical Prostatectomy Farhang Rabbani *, Luis Herran Yunis, Rodrigo Pinochet, Lucas Nogueira, Kinjal C. Vora, James A. Eastham, Bertrand Guillonneau, Vincent Laudone, Peter T. Scardino, Karim Touijer Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA Article info Article history: Accepted November 17, 2009 Published online ahead of print on November 25, 2009 Keywords: Complications Prostatectomy Laparoscopy Prostatic neoplasms Risk factors Comorbidity Please visit europeanurology to read and answer questions on-line. The EU-ACME credits will then be attributed automatically. Abstract Background: The lack of standardized reporting of the complications of radical prostatectomy in the literature has made it difficult to compare incidences across institutions and across different surgical approaches. Objective: To define comprehensively the incidence, severity, and timing of onset of medical and surgical complications of open retropubic prostatectomy (RP) and laparoscopic radical prostatectomy (LP) using a standardized reporting methodology to facilitate comparison. Design, setting, and participants: Between January 1999 and June 2007, 4592 consecutive patients underwent RP or LP without prior radiation or hormonal therapy. Median follow-up was 36.9 mo (interquartile range: ). Intervention: Open or laparoscopic radical prostatectomy. Measurements: All medical and surgical complications of radical prostatectomy were captured and graded according to the modified Clavien classification and classified by timing of onset. Results and limitations: There were 612 medical complications in 467 patients (10.2%) and 1426 surgical complications in 925 patients (20.1%). The overall incidences of early minor and major medical and surgical complications for RP were 8.5% and 1.5% for medical and 11.4% and 4.9% for surgical complications, respectively. The overall incidences of early minor and major medical and surgical complications for LP were 14.2% and 2.3% for medical and 23.1% and 6.6% for surgical complications, respectively. On multivariate analysis, LP approach was associated with a higher incidence of any grade medical and surgical complications but a lower incidence of major surgical complications than RP. Six hundred fifty-two men (14.2%) visited the emergency department, and 240 men (5.2%) required readmission. The main limitation is the retrospective nature. Conclusions: With standardized reporting, the incidence of some complications is higher than recognized in the literature. Although most complications are minor in severity, medical and surgical complications are observed in approximately 10% and 20% of patients, respectively. Accurate reporting of complications through a standardized methodology is essential for counseling patients regarding risk of complications, for identifying modifiable risk factors, and for facilitating comparison across institutions and approaches. # 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA. Tel ; Fax: address: rabbanif@mskcc.org (F. Rabbani) /$ see back matter # 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi: /j.eururo

2 372 EUROPEAN UROLOGY 57 (2010) Introduction With the introduction of laparoscopic radical prostatectomy (LP) and robot-assisted LP (RARP), there have been a number of publications comparing these more recent techniques to open radical retropubic prostatectomy (RP) [1 6]. Differences in patterns of practice make comparison of complications across different approaches difficult and even more challenging across different institutions. To facilitate comparison of complication rates, consistency and clarity in reporting is necessary, as some authors have advocated [7]. The more widespread use of grading schemes [8] in reporting complications has facilitated standardization to some degree. Martin et al [7] have identified 10 critical elements of accurate and comprehensive reports of surgical complications (Appendix A). Although capture of all complications may be impossible in a retrospective study due to poor documentation, even in prospective studies [1], some complication categories may not be reported. A review of the studies evaluating complication rates in the urologic oncology literature reported that only 2% met 9 or 10 of Martin et al s criteria and 21% met 7 or 8 criteria. The most commonly underreported criteria were complication definitions, complication severity/grade, outpatient data, comorbidities, and duration of the reporting period [9]. We sought to apply the standards set forth by Martin et al [7] in performing a comprehensive report on the complications of radical prostatectomy at our institution in an effort to encourage the use of standardized reporting in the literature and, thus, to facilitate comparison across institutions and surgical approaches and to aid in patient counseling. 2. Patients and methods Between January 1999 and June 2007, 4592 consecutive patients underwent radical prostatectomy (RP or LP) for adenocarcinoma of the prostate at our institution. Patients undergoing LP received lowmolecular-weight heparin starting before surgery and continued daily until discharge; patients undergoing RP did not routinely receive lowmolecular-weight heparin but had sequential compression boots. Table 1 Preoperative, intraoperative, and postoperative parameters stratified by prostatectomy approach Parameter All patients (n = 4592) n (%) RP (n = 3458) n (%) LP y (n = 1134) n (%) p value # Preoperative clinical parameters Age Median (IQR) 59.5 ( ) 59.4 ( ) 59.7 ( ) 0.26 Ethnicity White 4067 (88.6) 3081 (89.1) 986 (86.9) African American 317 (6.9) 234 (6.8) 83 (7.3) Other/unknown 208 (4.5) 143 (4.1) 65 (5.7) BMI* Median (IQR) 27.6 ( ) 27.7 ( ) 27.6 ( ) 0.73 Clinical stage T (62.4) 2056 (59.5) 808 (71.3) T (34.2) 1275 (36.9) 296 (26.1) <0.001 T3 150 (3.3) 121 (3.5) 29 (2.6) Tx 7 (0.2) 6 (0.2) 1 (0.09) Gleason score (58.3) 2029 (58.7) 650 (57.3) (33.6) 1126 (32.6) 418 (36.9) (8.0) 303 (8.8) 66 (5.8) Preoperative PSA, ng/ml z Median (IQR) 5.5 ( ) 5.6 ( ) 5.3 ( ) Neoadjuvant hormonal therapy 224 (4.9) 190 (5.5) 34 (3.0) ASA score (10.9) 424 (12.3) 77 (6.8) < (76.4) 2601 (75.2) 905 (79.8) (12.6) 428 (12.4) 152 (13.4) 4 1 (0.02) 1 (0.03) 0 (0) Modified Charlson comorbidity score** (8.8) 317 (9.2) 86 (7.6) (36.4) 1263 (36.5) 410 (36.2) (39.0) 1362 (39.4) 427 (37.7) (12.3) 401 (11.6) 162 (14.3) (2.7) 86 (2.5) 39 (3.4) 5 36 (0.8) 26 (0.8) 10 (0.9) Hypertension 1714 (37.3) 1255 (36.3) 459 (40.5) Hypercholesterolemia/hypertriglyceridemia 1623 (35.3) 1125 (32.5) 498 (43.9) <0.001 Diabetes 311 (6.8) 225 (6.5) 86 (7.6) 0.21 Coronary artery disease 328 (7.1) 220 ( (9.5) <0.001 Prior MI 98 (2.1) 65 (1.9) 33 (2.9) Comorbid disease Cardiac 355 (7.7) 238 (6.9) 117 (10.3) <0.001

3 EUROPEAN UROLOGY 57 (2010) Table 1 (Continued ) Parameter All patients (n = 4592) n (%) RP (n = 3458) n (%) LP y (n = 1134) n (%) p value # Vascular 398 (8.7) 270 (7.8) 128 (11.3) <0.001 Valvular heart disease 20 (0.4) 16 (0.5) 4 (0.4) 0.80 Dysrhythmia 133 (2.9) 106 (3.1) 27 (2.4) 0.23 Endocrine 400 (8.7) 294 (8.5) 106 (9.3) 0.38 Neurologic 19 (0.4) 14 (0.4) 5 (0.4) 0.80 Procoagulable disorder*** 55 (1.2) 45 (1.3) 10 (0.9) 0.26 Coagulopathy 6 (0.1) 5 (0.1) 1 (0.09) 1.0 Immunologic 26 (0.6) 17 (0.5) 9 (0.8) 0.24 Upper GI 357 (7.8) 259 (7.5) 98 (8.6) 0.21 Lower GI 83 (1.8) 53 (1.5) 30 (2.6) Pulmonary 339 (7.4) 251 (7.3) 88 (7.8) 0.58 Renal 21 (0.5) 11 (0.3) 10 (0.9) Hepatic 78 (1.7) 61 (1.8) 17 (1.5) 0.55 Musculoskeletal 200 (4.4) 157 (4.5) 43 (3.8) 0.28 Pathologic parameters Pathologic stage pt0 35 (0.8) 28 (0.8) 7 (0.6) 0.13 pt (69.4) 2385 (69.0) 801 (70.6) pt (27.7) 961 (27.8) 311 (27.4) pt4 99 (2.2) 84 (2.4) 15 (1.3) Nodal status N (88.4) 3227 (93.3) 833 (73.5) N1 N2 218 (4.7) 171 (4.9) 47 (4.1) <0.001 Nx 314 (6.8) 60 (1.7) 254 (22.4) Seminal vesicle invasion 302 (6.6) 260 (7.5) 42 (3.7) <0.001 Positive surgical margins 634 (13.8) 506 (14.6) 128 (11.3) Pathologic Gleason score (36.6) 1338 (38.7) 343 (30.2) (54.2) 1773 (51.3) 716 (63.1) < (7.1) 261 (7.5) 63 (5.6) Not graded due to pt0 35 (0.8) 28 (0.8) 7 (0.6) Not graded due to treatment effect^ 63 (1.4) 58 (1.7) 5 (0.4) Specimen weight, g**** Median (IQR) 50 (41 63) 50 (41 63) 50 ( ) 0.77 Intraoperative and postoperative parameters Bilateral PLND performed 4278 (93.2) 3398 (98.3) 880 (77.6) <0.001 Node count Median (IQR) 10 (7 15) 10 (6 15) 12 (8 16) <0.001 Operative time, min Median (IQR) 213 ( ) 202 ( ) 241 ( ) <0.001 Estimated blood loss, ml Median (IQR) 900 ( ) 1100 ( ) 250 ( ) <0.001 Blood transfusion 1945 (42.4) 1900 (55) 45 (4.0) <0.001 Mean units of blood transfused, no <0.001 Allogenic blood transfusion 581 (12.7) 538 (15.6) 43 (3.8) <0.001 Mean units of allogenic blood transfused, no <0.001 Mean drop in serum HGB from preoperative <0.001 to discharge, g/dl Length of stay, d Median (IQR) 3 (2 3) 3 (3 4) 2 (1 2) <0.001 Routine postoperative cystography performed 187 (4.1%) 61 (1.8) 126 (11.1) <0.001 Drain fluid sent for creatinine 775 (16.9%) 472 (13.6) 303 (26.7) <0.001 Catheter duration, d Median (IQR) 11 (9 15) 13 (10 15) 7 (7 10) <0.001 Prolonged pelvic drainage, >7 d 114 (2.5) 67 (1.9) 47 (4.1) <0.001 Follow-up, mo Median (IQR) 36.9 ( ) 45.5 ( ) 24.1 ( ) <0.001 ASA = American Society of Anesthesiologists; BMI = body mass index; HGB = hemoglobin; IQR = interquartile range; LP = laparoscopic prostatectomy; MI = myocardial infarction; PLND = pelvic lymph node dissection; PSA = prostate-specific antigen; RP = open radical retropubic prostatectomy. y Includes 97 robotic-assisted LPs. * BMI missing in 284 patients. z PSA missing in one patient. ASA score missing in four patients. ** Missing in three patients. *** Includes history of deep venous thrombosis, pulmonary embolus. **** Specimen weight missing in 225 patients. ^ Not graded due to prior hormonal therapy precluding assignment of Gleason score. # p values for categorical variables are for differences in distributions between RP and LP approaches.

4 374 EUROPEAN UROLOGY 57 (2010) Table 2 Incidence and main indications for reoperation, emergency department visit, and readmission Quality-of-care measure n (%) Main indications (n) Reoperation during initial admission 37 (0.8): Postoperative bleeding (24) RP 27 (0.8) Cystoscopic fulguration of bleeder (5) LP 10 (0.9), p = 0.74 Retained drain (4) Sigmoid perforation (1) Suspected small bowel obstruction (1) Ureteral reimplant (1) Bilateral percutaneous nephrostomy placement (1) Reoperation after discharge (other than incision of BNC or internal urethrotomy) 44 (1.0): Incisional hernia/dehiscence (21) RP 21 (0.6) Bowel ischemia/injury (6) LP 23 (2.0), p < Anastomotic disruption (5) Retained drain (3) Bladder calculi (3) Ureteral injury (2) Suture granuloma (2) Bladder clot evacuation (1) Replacement Foley catheter (1) Postoperative bleeding (1) Abscess drainage (1) Aortic valve replacement (1) ER visit 652 (14.2): Urinary retention/bladder neck contracture/decreased urine output (115) RP 454 (13.1) Lower extremity swelling/deep venous thrombosis (101) LP 198 (17.5), p < Drain/catheter complaints (89) Fever (74) Lymphocele (52) Wound complaints (48) Abdominal/flank pain (45) Urinary tract infection (36) Shortness of breath/pulmonary embolism (23) GI complaints (23) Penile/scrotal swelling (19) Readmission 240 (5.2): Lymphocele (57) RP 154 (4.5) Fever (46) LP 86 (7.6), p < Urinary tract infection (32) Urinary retention (17) Deep venous thrombosis (17) Pulmonary embolism (14) Abscess (15) Urinoma/urine leak (11) Abdominal pain (10) Wound infection (7) BNC = bladder neck contracture; ER = emergency room; GI = gastrointestinal; LP = laparoscopic prostatectomy; RP = open radical retropubic prostatectomy. Data were collected from a prospective prostatectomy database together with a prospective institutional morbidity database as well as retrospectively from all postoperative inpatient and outpatient billing records, inpatient and outpatient medical records including physician notes, operative notes, discharge summaries, nursing notes, and correspondence with local physicians outside our institution. Institutional review board approval was obtained for performing the study. All complications other than erectile dysfunction and incontinence, both medical and surgical, occurring at any time after surgery were captured including the inpatient stay as well as in the outpatient setting. They were classified as early (onset: 30 d), intermediate (onset: d), or late (onset: >90 d) complications, depending on the date of onset. For late complications, those deemed to be related or possibly related to the prostatectomy were captured, regardless of how long after prostatectomy the onset occurred. All complications were recorded with a grade (I, II, IIIa, IIIb, IVa, IVb, or V) assigned according to the modified Clavien classification [8] and were grouped into subcategories of medical and surgical complications. Data collected and included in the multivariate analysis as covariates included prostatectomy approach, whether pelvic lymph node dissection (PLND) was performed, age, ethnicity, body mass index (BMI), clinical stage, biopsy Gleason score, preoperative prostate-specific antigen (PSA), prior treatment (including androgendeprivation therapy [ADT]), specific comorbidities as well as American Society of Anesthesiologists (ASA) physical status classification score [10] and modified Charlson score [11], pathologic stage and nodal status, surgical margin status, specimen weight, operative time, and estimated blood loss (EBL). Additional data collected included preoperative and postoperative serum hemoglobin levels, transfusion data, intensive care unit (ICU) admissions, reoperations, length of stay (LOS), emergency room (ER) visits or readmissions either at our institution or elsewhere, vital status, and date of death. Appendix B clarifies the definition of some of the complications. The primary indication for allogenic blood transfusion was symptomatic anemia Statistical analysis The Pearson x 2 test, the median test, and the Kruskal-Wallis test were used to evaluate the distributions of categorical and continuous variables, as appropriate [12]. Correlation was tested with the Spearman correlation coefficient. Multivariate Cox proportional hazards analysis was used with forward stepwise variable selection to assess significant

5 EUROPEAN UROLOGY 57 (2010) Table 3 Association of preoperative, pathologic, and intraoperative parameters with medical and surgical complications Parameter Medical complications Surgical complications Present n (%) Absent n (%) p value* Present n (%) Absent n (%) p value* Age Median (IQR) 60.3 ( ) 59.4 ( ) ( ) 59.3 ( ) Ethnicity White 402 (9.9) 3665 (90.1) (19.7) 3264 (80.3) African American 42 (13.2) 275 (86.8) 80 (25.2) 237 (74.8) Other/unknown 23 (11.1) 185 (88.9) 42 (20.2) 166 (79.8) BMI* Median (IQR) 27.9 ( ) 27.6 ( ) ( ) 27.5 ( ) Clinical stage T1 312 (10.9) 2552 (89.1) (20.4) 2279 (79.6) 0.50 T2 133 (8.5) 1438 (91.5) 303 (19.3) 1268 (80.7) T3 21 (14) 129 (86) 36 (24) 114 (86) Tx 1 (14.3) 6 (85.7) 1 (14.3) 6 (85.7) Biopsy Gleason score (9.2) 2432 (80.8) (19.5) 2156 (80.5) (11.2) 1371 (88.8) 319 (20.7) 1225 (79.3) 8 47 (12.7) 322 (87.3) 83 (22.5) 286 (87.5) Preoperative PSA, ng/mlz Median (IQR) 5.7 ( ) 5.5 ( ) ( ) 5.4 ( ) Neoadjuvant hormonal therapy Yes 20 (8.9) 204 (90.1) (20.1) 179 (79.9) 0.98 No 447 (10.2) 3921 (89.8) 880 (20.1) 3488 (79.9) ASA score 1 50 (10.0) 451 (90.0) (16.6) 418 (83.4) (9.8) 3162 (90.2) 698 (19.9) 2808 (80.1) (12.6) 508 (87.4) 144 (24.8) 437 (75.2) Modified Charlson score 0 33 (8.2) 370 (91.8) (16.1) 338 (83.9) < (8.6) 1529 (91.4) 299 (17.9) 1374 (82.1) (10.8) 1595 (89.2) 379 (21.2) 1410 (78.8) 3 71 (12.6) 492 (87.4) 142 (25.2) 421 (74.8) 4 19 (15.2) 106 (84.8) 28 (22.4) 97 (77.6) 5 6 (16.7) 30 (83.3) 11 (30.6) 25 (69.4) Hypertension Yes 200 (11.7) 1514 (88.3) (22.1) 1336 (77.9) No 267 (9.3) 2611 (90.7) 547 (19.0) 2331 (81.0) Hypercholesterolemia/Hypertriglyceridemia Yes 164 (10.1) 1459 (89.9) (19.3) 1310 (80.7) 0.28 No 303 (10.2) 2666 (89.8) 612 (20.6) 2357 (79.4) Diabetes Yes 45 (14.5) 266 (85.5) (25.1) 233 (74.9) No 422 (9.9) 3859 (90.1) 847 (19.8) 3434 (80.2) Coronary artery disease Yes 33 (10.1) 295 (89.9) (20.7) 260 (79.3) 0.78 No 434 (10.2) 3830 (89.8) 857 (20.1) 3407 (89.9) Prior MI Yes 11 (11.2) 87 (88.8) (16.3) 82 (83.7) 0.34 No 456 (10.1) 4038 (89.9) 909 (20.2) 3585 (79.8) Valvular heart disease Yes 6 (30.0) 14 (70.0) (45.0) 11 (55.0) No 461 (10.1) 4111 (89.9) (20.0) 3656 (80.0) Dysrhythmia Yes 23 (17.3) 110 (82.7) (22.6) 103 (77.4) 0.48 No 444 (10.0) 4015 (90.0) (20.1) 3564 (79.9) Procoagulable disorder Yes 11 (20.0) 44 (80.0) < (34.5) 36 (65.5) No 456 (10.1) 4081 (89.9) (20.0) 3631 (80.0)

6 376 EUROPEAN UROLOGY 57 (2010) Table 3 (Continued ) Parameter Medical complications Surgical complications Present n (%) Absent n (%) p value* Present n (%) Absent n (%) p value* Coagulopathy Yes 1 (16.7) 5 (83.3) < (50.0) 3 (50.0) No 466 (10.2) 4120 (89.8) 922 (20.1) 3664 (79.9) Pulmonary comorbidity Yes 54 (15.9) 285 (84.1) 91 (26.8) 248 (73.2) No 413 (9.7) 3840 (90.3) 834 (19.6) 3419 (80.4) Renal comorbidity Yes 4 (19.0) 17 (81.0) 12 (57.1) 9 (42.9) <0.001 No 463 (10.1) 4108 (89.9) 913 (20.0) 3658 (80.0) Surgical approach RP 303 (8.8) 3155 (91.2) 647 (18.7) 2811 (81.3) <0.001 LP 164 (14.5) 970 (85.5) 278 (24.5) 856 (75.5) Pathologic stage pt0 3 (8.6) 32 (91.4) (28.6) 25 (71.4) 0.61 pt2 324 (10.2) 2862 (89.8) 635 (19.9) 2551 (80.1) pt3 130 (10.2) 1142 (89.8) 261 (20.5) 1011 (79.5) pt4 10 (10.1) 89 (89.9) 19 (19.2) 80 (80.8) Nodal status N0 391 (9.6) 3669 (90.4) 824 (20.3) 3236 (79.7) N1 N2 34 (15.6) 184 (84.4) (23.9) 166 (76.1) Nx 42 (13.4) 272 (86.6) 49 (15.6) 265 (84.4) Positive surgical margins Yes 68 (10.7) 566 (89.3) (22.1) 494 (87.8) 0.19 No 399 (10.1) 3559 (89.9) 785 (19.8) 3173 (80.2) Pathologic Gleason score (10.1) 1511 (89.9) 315 (18.7) 1366 (81.3) (9.7) 2248 (90.3) (20.8) 1971 (79.2) (14.2) 278 (85.8) 71 (21.9) 253 (78.1) Specimen weight, g Median (IQR) 52.5 ( ) 50 (41 62) (42 65) 50 (41 62) EBL, ml Median (IQR) 800 ( ) 900 ( ) ( ) 900 ( ) 0.91 Blood transfusion Yes 233 (12.0) 1712 (88.0) < (23.3) 1491 (76.7) <0.001 No 234 (8.8) 2411 (91.2) 470 (17.8) 2175 (82.2) Operative time (min) Median (IQR) 225 ( ) 210 ( ) < ( ) 210 ( ) <0.001 ASA = American Society of Anesthesiologists; BMI = body mass index; EBL = estimated blood loss; IQR = interquartile range; LP = laparoscopic prostatectomy; MI = myocardial infarction; PSA = prostate-specific antigen; RP = open radical retropubic prostatectomy. * The p values for categorical variables are for comparison of incidence of complications across values of the parameter; the p values for continuous variables are for comparison of medians. independent predictors of medical and surgical complications. Statistical analyses were performed using the SPSS statistical package (SPSS Inc, Chicago, IL, USA). 3. Results 3.1. Patient population Table 1 summarizes the clinical characteristics of the 4592 patients by prostatectomy approach with open RP performed in 3458 men (75.3%) and LP (including 97 RARP cases) in 1134 men (24.7%). Prior treatment in 246 patients consisted of prior chemotherapy (n = 45) or hormonal therapy (n = 224). Median patient age was 59.5 yr (interquartile range [IQR]: ). The patient population was generally healthy, with an ASA score 2 in 4007 men (87.3%) and a modified Charlson score <2 in 2076 men (45.2%) Operative and pathologic characteristics Table 1 summarizes the intraoperative and pathologic characteristics as well as postoperative parameters, stratified by prostatectomy approach. Regional anesthesia consisting of epidural and/or spinal anesthesia was used in 744 RP patients (21.5%), with 726 of these cases performed by one surgeon; for this surgeon, there was no statistically significant difference in median EBL for the 726 patients having regional anesthesia (median: 1500 ml; IQR: ) versus the 303 patients not having regional anesthesia (median: 1300 ml; IQR: ) ( p = 0.092) Postoperative course ICU admission was required for 11 men (0.2%) during the initial admission and for 4 men (0.1%) at readmission.

7 EUROPEAN UROLOGY 57 (2010) The LOS was longer for patients with a higher modified Charlson comorbidity score (Spearman correlation coefficient: 0.054; p < 0.001). There were six mortalities (0.1%): three from cardiac-related causes (one of whom also had a pulmonary embolus), one from respiratory failure due to pulmonary fibrosis, and two from unknown causes. Table 2 lists the incidences and main indications for reoperation, ED visits, and readmission Complications There were 612 medical complications in 467 patients (10.2%) and 1426 surgical complications in 925 patients (20.1%). The number of RP and LP patients with medical complications was 303 (8.8%) and 164 (14.5%) ( p < 0.001). The number of RP and LP patients with surgical complications was 647 (18.7%) and 278 (24.5%) ( p < 0.001). The association of preoperative, pathologic, and intraoperative parameters with medical and surgical complications is shown in Table 3. On univariate analysis, medical complications were more commonly seen with older age, higher Gleason score, greater modified Charlson score, hypertension, diabetes, dysrhythmia, procoagulable disorder, pulmonary and valvular heart disease, laparoscopic approach, larger prostate size, and longer operative duration. Surgical complications were more commonly seen with older age; African American ethnicity; greater BMI; higher PSA; greater ASA and modified Charlson scores; hypertension; diabetes; procoagulable disorder; pulmonary, renal, and valvular heart disease; laparoscopic approach; larger prostate size; and longer operative duration. Table 4 lists the predictors of medical and surgical complications on multivariate Cox proportional hazards analysis. On multivariate analysis, the LP approach was associated with a higher incidence of any grade medical and surgical complications but a lower incidence of major surgical complications than RP. Significant independent predictors of major medical complications include diabetes; pulmonary, vascular, and valvular heart disease; prior neoadjuvant ADT; larger prostate size; and higher biopsy Gleason score. Significant independent predictors of major surgical complications include open retropubic approach, greater modified Charlson score, procoagulable disease, greater EBL, greater BMI, and African American or other ethnicity. The frequency of minor (grade I II) and major (grade III V) medical and surgical complications, stratified by prostatectomy approach, are presented in Tables 5 and 6 (and in Appendices C and D), respectively. With the exception of major surgical complications in RP patients, most complications present in the early postoperative period. Bladder neck contractures account for most of the intermediate and long-term major surgical complications, accounting for the higher rate of major surgical complications in RP as compared with LP patients. Table 7 summarizes the three most frequent minor and major medical and surgical complications for each follow-up period. Table 4 Predictors of medical and surgical complications on multivariate analysis Predictor Hazard ratio (95% CI) p value Any grade medical complication Surgical approach: LP vs RP 1.9 ( ) <0.001 Clinical stage T2 vs T ( ) T3 vs T1 0.8 Valvular heart disease 2.8 ( ) Procoagulable disease 2.0 ( ) Pulmonary comorbidity 1.7 ( ) <0.001 Dysrhythmia 1.7 ( ) Diabetes 1.4 ( ) Log 2 (specimen weight) 1.4 ( ) <0.001 EBL* 1.02 ( ) Biopsy Gleason score 7 vs ( ) vs ( ) Major medical complication Valvular heart disease 7.7 ( ) Pulmonary comorbidity 2.7 ( ) Vascular disease 2.6 ( ) Neoadjuvant ADT 2.5 ( ) Log 2 (specimen weight) 2.4 ( ) <0.001 Diabetes 2.1 ( ) Biopsy Gleason score 7 vs ( ) vs Any grade surgical complication Surgical approach: LP vs RP 1.6 ( ) <0.001 PLND performed 1.7 ( ) EBL* 1.02 ( ) <0.001 Modified Charlson score 1.11 ( ) BMI 1.03 ( ) Renal comorbidity 3.3 ( ) <0.001 Valvular heart disease 2.7 ( ) Pulmonary comorbidity 1.4 ( ) Ethnicity African American vs white 1.3 ( ) Log 2 PSA 1.08 ( ) Year of surgery 1.05 ( ) Operative duration (h) 1.0 ( ) Major surgical complication Modified Charlson score 1.2 ( ) <0.001 Surgical approach: LP vs RP 0.70 ( ) EBL* 1.02 ( ) Procoagulable disease 2.0 ( ) BMI 1.03 ( ) Ethnicity African American vs white 1.4 ( ) Other/unknown vs white 1.6 ( ) ADT = androgen deprivation therapy; BMI = body mass index; CI = confidence interval; EBL = estimated blood loss; PLND = pelvic lymph mode dissection; PSA = prostate-specific antigen. * Odds ratio for each 100 ml. 4. Discussion With the introduction of any surgical technique, there is a need to evaluate the complication rate in a sound and consistent manner to allow comparison across institutions and across different approaches. In a review of 119 articles in the surgical literature, Martin et al [7] developed 10 criteria to judge the quality of complication reporting.

8 378 EUROPEAN UROLOGY 57 (2010) Table 5 Frequency of minor and major medical complications stratified by prostatectomy approach Complication Minor (grade I II) Major (grade III V) Total RP LP Total RP LP n (%) n (%) n (%) n (%) n (%) n (%) Medical complications at 30 d Overall Cardiac Pulmonary Gastrointestinal Neurologic Renal Venous thromboembolism Infectious Medical complications at d Overall Cardiac Pulmonary Gastrointestinal Neurologic Renal Venous thromboembolism Infectious Medical complications at >90 d Overall Cardiac Pulmonary Gastrointestinal Neurologic Renal Venous thromboembolism Infectious LP = laparoscopic prostatectomy (including robot-assisted); RP = open radical retropubic prostatectomy. Of the 10 criteria, no articles met all criteria, 2% met 9 criteria, and 38% met 7 or 8 criteria; 52% met 4 criteria. In the present study, we have reported the complications of radical prostatectomy using the 10 criteria set forth by Martin et al [7]. To ensure that the reporting has been comprehensive, complications have been categorized as medical or surgical, by organ system as well as by timing of onset and grade. In a recent review of the complications of radical prostatectomy, Berryhill et al [4] acknowledged the lack Table 6 Frequency of minor and major surgical complications stratified by prostatectomy approach Complication Minor (grade I II) Major (grade III V) Total RP LP Total RP LP n (%) n (%) n (%) n (%) n (%) n (%) Surgical complications at 30 d Overall Urologic Lymphovascular Infectious Gastrointestinal Neurologic Musculoskeletal Wound complications Surgical complications at d Overall Urologic Lymphovascular Infectious Gastrointestinal Neurologic Musculoskeletal Wound complications

9 EUROPEAN UROLOGY 57 (2010) Table 6 (Continued ) Complication Minor (grade I II) Major (grade III V) Total RP LP Total RP LP n (%) n (%) n (%) n (%) n (%) n (%) Surgical complications at >90 d Overall Urologic Lymphovascular Infectious Gastrointestinal Neurologic Musculoskeletal Wound complications LP = laparoscopic prostatectomy (including robot-assisted); RP = open radical retropubic prostatectomy. Table 7 Most frequent medical and surgical complications by prostatectomy approach and timing of onset Grade Medical Surgical RP LP RP LP Early (30 d) Minor UTI 1.9% UTI 6.0% Urinoma/urine leak 2.4% Urinoma/urine leak 7.4% DVT 1.1% Ileus 1.9% Wound infection 2.3% Wound infection 3.5% Arrhythmia 0.8% DVT 1.1% Urinary retention 2.1% Urinary retention 2.4% Major Hypotension 0.4% Hypotension 0.5% Lymphocele 0.8% Urinoma/urine leak 1.3% Respiratory distress 0.2% PE 0.4% Rectal/SB/LB injury 0.7% Lymphocele 1.1% Acute renal insufficiency 0.2% MI/ischemia 0.3% Hematoma 0.5% Abscess 1.1% Intermediate (31 90 d) Minor UTI 0.4% UTI 1.4% Lymphocele 0.3% Lymphocele 1.1% DVT 0.1% Respiratory distress 0.2% Urinary retention 0.3% Obturator nerve injury/palsy 0.4% PE 0.09% Hydronephrosis 0.09% Inguinal hernia 0.3% Major Sepsis 0.03% BNC 2.3% Lymphocele 0.4% Urethral stricture 0.6% Incisional hernia 0.2% Urinary retention 0.4% Urethral stricture 0.2% Late (>90 d) Minor UTI 0.5% UTI 0.4% Urinary retention 0.2% Incisional hernia 0.6% Acute renal insufficiency 0.06% DVT 0.09% Lymphocele 0.2% Inguinal hernia 0.4% Respiratory distress 0.03% Inguinal hernia 0.2% Lymphocele 0.3% Major CVA/TIA 0.09% BNC 2.8% Incisional hernia 1.1% Acute renal insufficiency 0.03% Inguinal hernia 1.2% BNC 0.7% Urethral stricture 0.4% Inguinal hernia 0.5% BNC = bladder neck contracture; CVA = cerebrovascular accident; DVT = deep venous thrombosis; LB = large bowel; LP = laparoscopic prostatectomy (including robot-assisted); MI = myocardial infarction; PE = pulmonary embolism; RP = open radical retropubic prostatectomy; SB = small bowel; TIA = transient ischemic attack; UTI = urinary tract infection. of a single reporting standard as well as inherent selection biases that are present in single-institution case series. There have been a number of studies evaluating the complications of RP [1,5,6,13 21], LP[1,2,5,22 28], and RARP [2,6,29 31]. Of the 12 studies evaluating complications of RP [1,5,6,13 21], only 2 studies provided definitions of complications (criterion 4) and 4 studies indicated duration of follow-up (criterion 2), graded the severity of complications (criterion 8), or included risk factors in the analysis (criterion 10). Of 9 studies evaluating complications of LP [1,2,5,22 27], only 2 studies included risk factors (criterion 10), 3 studies provided definitions (criterion 4), and 4 studies indicated duration of follow-up (criterion 2). Of five studies evaluating complications of RARP [2,6,29 31], only one study provided complication definitions (criterion 4) or included risk factors (criterion 10), and two studies indicated duration of follow-up (criterion 2), included procedure-specific complications (criterion 7), or graded the severity of complications (criterion 8). The detailed listing of medical and surgical complications of RP and LP are presented in Tables 5 and 6 (and in Appendices C and D). The higher rates reported in our study as compared with those in the literature may be explained in part by our reporting of all complications systematically by organ system rather than by only reporting the more

10 380 EUROPEAN UROLOGY 57 (2010) Table 8 Incidence of complications in the present series over all follow-up periods as compared with contemporary published series with at least 100 patients* Complication RP LP/RARP Present series, % Literature, % [reference] Present series % Literature %, [reference] Medical Cardiac MI/ischemia [1,5,6,13,14,16,17,21,31] [1,2,5,6,31] Arrhythmia [14 16], 4.8 [17] 0.7 N/R Hypotension [1], 5.2 [17] [1] Pulmonary Respiratory distress [31], 1.2 [17] [25], 0.7 [31] Pneumonia [14,16,17] [2] Gastrointestinal Ileus [5,6,14 18,31] [2,5,6,22,25 28,31] Gastrointestinal bleed [17] 0.2 N/R Diarrhea [14,17,18] [2] Pancreatitis [16] 0.09 N/R Elevated LFTs [17], 0.5 [19] 0 N/R Neurologic CVA/TIA [14,16 18,31] [2,24,31] Epidural complications 0.3 N/R 0 N/R Psychiatric [16], 0.5 [19] 0 N/R Renal Acute renal insufficiency [31], 0.4 [17] [2,31] Venous thromboembolism [1,6,13,14] [1,2,6,24,28] Pulmonary embolism [15,21,31] [25,27,31] Deep venous thrombosis [16 18,21,31] [31] Infectious Urinary tract infection [16 18,31] [29,31] Drain fluid infection 0.4 N/R 0.5 N/R Sepsis [5,17,18,31] [5,31] Cellulitis 0.4 N/R [2,27] Surgical Urologic Urinoma/urine leak [5,14 17,21,31], [2,22,24 26,28,31] 12.6 [16], 17.3 [32] Bladder neck contracture [1,13,14,21,31], [1,2,25 28,29,31], 5.3[5] 13.8 [15], 17.9 [5] Urethral stricture [1,15,31], 4.1[21] [1], 0.5 [29], 3.9[31] Urinary retention [1,14,16,17,31] [1,2,25,27,31] Hydronephrosis [16,17,19,31] [22,27,31] Ureteral injury [1,14,15,17,18] [1,2,22] Fistula [19] [2,24,25,28] Epididymitis [17], 0.8 [18] [2,29] Bladder calculus/suture/clip 0.6 N/R [27] False passage 0.1 N/R 0.1 N/R Retained/defective catheter [18], 0.5 [16], 1.5 [17] 0.1 N/R Lymphovascular Lymphocele [5,6,14 18,21,31] [2,5,6,31], 5.0[29] Hematoma [5,6,16,18,31] [2,5,6,22,29,31] IV access complication 0.1 N/R 0.1 N/R Infectious Abscess [15,18,21,31] [24,25,27,31] GI Rectal/Small bowel/large bowel injury [5,6,14,17,18,21], 2.9 [21], 4.9 [15] [2,6,22,24 27,30], 1.9 [2], 2.3[5] Small bowel obstruction [18] [29] Large bowel obstruction 0 N/R 0.1 N/R Neurologic [6,13] [2,5,6,22] Obturator nerve injury/palsy [16,18], 0.5 [19], 2.0 [6] [2] Femoral palsy [14], 0.5 [19] [2] Upper extremity palsy [19], 1.1 [17] [2], 1.0 [26] Meralgia paresthetica 0.2 N/R 0.5 N/R Musculoskeletal Inguinal hernia [33] [33] Compartment syndrome 0 N/R [27] Osteitis pubis 0.03 N/R 0 N/R Wound complications Wound infection [5,16,17], 13.8 [15] [5,29] Wound seroma [14], 1.3 [18] 0.3 N/R

11 EUROPEAN UROLOGY 57 (2010) Table 8 (Continued ) Complication RP LP/RARP Present series, % Literature, % [reference] Present series % Literature %, [reference] Dehiscence [18,31], 1.0[6], 1.4 [16] [6,22,31] Incisional hernia [14], 2.8 [31] [29], 1.0[26], 4.0 [31] Retained drain [16] [2] CVA = cerebrovascular accident; LFT = liver function tests; LP = laparoscopic prostatectomy (including robot-assisted); MI = myocardial infarction; N/R = not reported; RARP = robotic-assisted laparoscopic radical prostatectomy; RP = open radical retropubic prostatectomy; TIA = transient ischemic attack. * Expressed as percent with outliers reported separately. common complications. The higher rates may also be explained in part by our reporting of the complication frequency rather than the number of patients with one or more complications as the numerator. This approach gives a more accurate reflection of the true magnitude of complications because some individuals may have multiple complications of varying grades and of a different nature (medical vs surgical). Table 7 presents the most common medical and surgical complications by prostatectomy approach and timing of onset. Most complications, with the exception of bladder neck contracture/stricture disease, urinary retention, inguinal and incisional hernias, and lymphoceles, present in the early postoperative period. On multivariate analysis, the LP approach was associated with a higher incidence of any grade medical and surgical complications but a lower incidence of major surgical complications than RP. The comorbidities were more significant in the LP group, potentially accounting for some of the increased medical complication rate; however, this increased rate of medical complications in the LP group was still present on multivariate analysis. Other authors comparing surgical approach have identified no difference in complication rates [31] between the two approaches or a higher complication rate for RP versus LP [5,6]. However, these studies did not perform multivariate analysis adjusting for other determinants of outcome in evaluating differences between approaches and did not systematically report on all complications, potentially allowing some more minor complications perhaps to be overlooked. This highlights the importance of standardized reporting to facilitate such comparisons. Our finding of a higher rate of ER visit, readmission, and reoperation in the LP group was previously reported by Touijer et al [1]. This may be in part due to a worse comorbidity profile in the LP group and also due to a shorter course of hospitalization where more of the postoperative complaints present in the outpatient setting. Table 8 presents the complications in the present series as compared with those in the literature having at least 100 patients. In the present series, the incidence of most complications were comparable to those reported in the literature, except for a higher incidence of urinary tract infection, hydronephrosis, lymphocele, obturator palsy, wound infection, and incisional hernia in the patients undergoing LP in our series as compared with the literature. The higher incidences reported in our study may be largely due to the accurate methodology of reporting complications, giving rise to increased complication rates, much as has been reported in the cystectomy literature [34,35] with use of Martin et al s reporting criteria [7]. The higher incidence of urinary tract infection is likely due to most LP patients being treated by a surgeon who does not use antibiotic prophylaxis for catheter removal and possible underreporting in the literature of a complication that is deemed minor. The higher incidence of hydronephrosis in our LP cohort may be due to edema at the ureteral orifices from a non bladder neck sparing procedure and possibly due to a greater proportion of patients undergoing an extended (standard) PLND. The higher incidence of lymphocele and obturator palsy in our cohort of LP patients is likely due to perioperative use of low-molecular-weight heparin in regard to lymphoceles and a more extensive PLND in most patients compared with LP/RARP series in the literature. Many LP/RARP series in the literature report <20% of patients in the series undergoing PLND [22,25,26], whereas only two series report that PLND was performed on all patients [2,31], and some do not mention the proportion of patients undergoing PLND [6,27,29,30]. Our study has a number of limitations. First, it is retrospective and, as such, may not thoroughly capture all complications that occurred elsewhere and were not reported to our institution or were deemed minor and not recorded. Second, our series represents the outcomes for surgeons at a cancer center, many of whom have a practice limited to radical prostatectomy; as such, the results may not be representative of those obtained by general urologists in the community setting. Third, for some complications such as urine leak, whether drain fluid was submitted for analysis or whether routine cystography was performed depended on the practices of individual surgeons and differed across different prostatectomy approaches. Furthermore, the duration of follow-up was shorter in the LP group, favoring this group with regard to the incidence of complications. The limited experience with robotic prostatectomy is another limitation because most minimally invasive prostatectomies are now performed robotically, with LP performed by a relatively few highly skilled surgeons worldwide. We have not reported on erectile dysfunction and incontinence in the present report because these significant topics merit separate analyses. Nevertheless, the strength of the present study is that it is the largest series reporting on complications comprehensively in a

12 382 EUROPEAN UROLOGY 57 (2010) standardized fashion, which may aid in more accurate reporting of the true incidence of complications. Accurate reporting of complications through a standardized methodology is essential for counseling patients regarding risk of complications, for identifying modifiable risk factors, and for facilitating comparison across institutions and approaches. 5. Conclusions Using standardized criteria, medical and surgical complications were present in 8.8% and 18.7% of RP patients, respectively, and in 14.5% and 24.5% of LP patients, respectively. Although best examined prospectively, these findings may be useful to counsel patients, to identify potentially modifiable risk factors, and to facilitate comparisons between institutions and techniques. With further standardized reporting from multiple institutions, a risk stratification scheme may be able to be devised and validated in a multi-institutional setting to allow a more individualized approach to preoperative counseling. Author contributions: Farhang Rabbani had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Rabbani. Acquisition of data: Rabbani, Herran-Yunis, Vora, Pinochet, Nogueira. Analysis and interpretation of data: Rabbani. Drafting of the manuscript: Rabbani. Critical revision of the manuscript for important intellectual content: Rabbani, Eastham, Guillonneau, Laudone, Scardino, Touijer. Statistical analysis: Rabbani. Obtaining funding: Scardino. Administrative, technical, or material support: Scardino, Rabbani. Supervision: Rabbani. Other (specify): None. Financial disclosures: I certify that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None. Funding/Support and role of the sponsor: The Sidney Kimmel Center for Prostate and Urologic Cancers helped manage the data. Appendix A Ten critical elements of accurate and comprehensive reports of surgical complications [7] 1. Definition of the method of data accrual 2. Indication of duration of follow-up 3. Inclusion of outpatient information 4. Definitions of complications 5. Listing of the mortality rate and causes of death 6. Indication of the morbidity rate and total complications 7. Inclusion of procedure-specific complications 8. Use of a severity grade 9. Inclusion of length-of-stay data 10. Inclusion of risk factors Appendix B Definitions of complications Acute renal insufficiency: Postoperative serum creatinine >1.5 mg/dl in a patient with normal preoperative serum creatinine. Arrhythmia: Includes new-onset atrial fibrillation, atrial flutter, and premature ventricular contractions. Hematoma: Includes patients with postoperative bleeding in the surgical site. Ileus: Abdominal distension and/or bowel hypoactivity resulting in a departure from routine postoperative care (inability to advance the diet according to the clinical care pathway, requiring nasogastric tube placement, readmission/reassessment/medical consultation, need for imaging). Lymphocele: Identified in patients undergoing imaging due to symptoms suspicious for lymphocele, such as fever, abdominal pain, or lower extremity swelling, because routine imaging for lymphocele was not performed. Prolonged pelvic drainage: Removal of the pelvic drain beyond 7 d postoperatively. Urinary retention: Includes occlusion of the catheter with clot and inability to void after catheter removal or due to bladder outlet obstruction related to bladder neck contracture. Urinoma/urine leak: Evidence of extravasation on imaging (computed tomography [CT] scan or cystogram) or fluid collection on CT scan consistent with a urinoma or drain fluid creatinine 1.5 mg/dl (if this is also greater than serum creatinine). Appendix C Frequency of minor and major medical complications stratified by prostatectomy approach Complication Minor (grade I II) Major (grade III V) Total RP LP Total RP LP n (%) n (%) n (%) n (%) n (%) n (%) Medical complications at 30 d Overall Cardiac MI/ischemia Arrhythmia* Hypotension** Pulmonary Respiratory distress Pneumonia

13 EUROPEAN UROLOGY 57 (2010) Appendix C (Continued ) Complication Minor (grade I II) Major (grade III V) Total RP LP Total RP LP n (%) n (%) n (%) n (%) n (%) n (%) Gastrointestinal Ileus Gastrointestinal bleed y Diarrhea Pancreatitis Elevated LFTs Neurologic CVA/TIA z Epidural complications Psychiatric Renal Acute renal insufficiency Venous thromboembolism PE DVT Infectious UTI Drain fluid infection Sepsis Cellulitis Medical complications at d Overall Cardiac Arrhythmia* Pulmonary Respiratory distress Gastrointestinal Neurologic CVA/TIA z Renal Acute renal insufficiency Venous thromboembolism PE DVT Infectious UTI Drain fluid infection Sepsis Cellulitis Medical complications at >90 d Overall Cardiac Pulmonary Respiratory distress Gastrointestinal Neurologic CVA/TIA z Renal Acute renal insufficiency Venous thromboembolism DVT Infectious UTI CVA = cerebrovascular accident; DVT = deep venous thrombosis; LFT = liver function test; LP = laparoscopic prostatectomy (including robot-assisted); MI = myocardial infarction; PE = pulmonary embolism; RP = open radical retropubic prostatectomy; TIA = transient ischemic attack; UTI = urinary tract infection. * Arrhythmia: New-onset atrial fibrillation, atrial flutter, premature ventricular contractions. ** Includes vasovagal episodes. y Gastrointestinal bleed includes gastritis/esophagitis. z Includes visual field defect.

14 384 EUROPEAN UROLOGY 57 (2010) Appendix D Frequency of minor and major surgical complications stratified by prostatectomy approach Complication Minor (grade I II) Major (grade III V) Total RP LP Total RP LP n (%) n (%) n (%) n (%) n (%) n (%) Surgical complications at 30 d Overall Urologic Urinoma/urine leak Bladder neck contracture Urethral stricture Urinary retention Hydronephrosis Ureteral injury Fistula Epididymitis Bladder calculus/suture/clip False passage Retained/defective catheter Lymphovascular Lymphocele Hematoma IV access complication Infectious Abscess Gastrointestinal Rectal/SB/LB injury SB obstruction LB obstruction Neurologic Obturator nerve injury/palsy Femoral palsy Upper extremity palsy Meralgia paresthetica Musculoskeletal Inguinal hernia Compartment syndrome Wound complications Wound infection Wound seroma Dehiscence Incisional hernia Retained drain Surgical complications at d Overall Urologic Urinoma/urine leak Bladder neck contracture Urethral stricture Urinary retention Hydronephrosis Epididymitis Bladder calculus/suture/clip Lymphovascular Lymphocele Hematoma IV access complication Infectious Abscess Gastrointestinal SB obstruction Neurologic Obturator nerve injury/palsy Femoral palsy Upper extremity palsy Meralgia paresthetica Musculoskeletal Inguinal hernia Osteitis pubis Wound complications

15 EUROPEAN UROLOGY 57 (2010) Appendix D (Continued ) Complication Minor (grade I II) Major (grade III V) Total RP LP Total RP LP n (%) n (%) n (%) n (%) n (%) n (%) Wound infection Wound seroma Incisional hernia Retained drain Surgical complications at >90 d Overall Urologic Bladder neck contracture Urethral stricture Urinary retention Hydronephrosis Epididymitis Bladder calculus/suture/clip False passage Lymphovascular Lymphocele Infectious Abscess Gastrointestinal Neurologic Meralgia paresthetica Musculoskeletal Inguinal hernia Wound complications Wound infection Incisional hernia IV = intravenous; LB = large bowel; LP = laparoscopic prostatectomy (including robot-assisted); RP = open radical retropubic prostatectomy; SB = small bowel. References [1] Touijer K, Eastham JA, Secin FP, et al. Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to J Urol 2008;179: [2] Hu JC, Nelson RA, Wilson TG, et al. Perioperative complications of laparoscopic and robotic assisted laparoscopic radical prostatectomy. J Urol 2006;175: [3] Guazzoni G, Cestari A, Naspro R, et al. Intra- and peri-operative outcomes comparing radical retropubic and laparoscopic radical prostatectomy: results from a prospective, randomised, singlesurgeon study. Eur Urol 2006;50: [4] Berryhill Jr R, Jhaveri J, Yadav R, et al. Robotic prostatectomy: a review of outcomes compared with laparoscopic and open approaches. Urology 2008;72: [5] Rassweiler J, Seemann O, Schulze M, Teber D, Hatzinger M, Frede T. Laparoscopic versus open radical prostatectomy: a comparative study at a single institution. J Urol 2003;169: [6] Tewari A, Srivasatava A, Menon M, members of the VIP team. A prospective comparison of radical retropubic and robot-assisted prostatectomy: experience in one institution. BJU Int 2003;92: [7] Martin II RC, Brennan MF, Jaques DP. Quality of complication reporting in the surgical literature. Ann Surg 2002;235: [8] Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240: [9] Donat SM. Standards for surgical complication reporting in urologic oncology: time for a change. Urology 2007;69: [10] Saklad M. Grading of patients for surgical procedures. Anesthesiology 1941;2: [11] Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol 1994;47: [12] Bryman A, Cramer D. Quantitative data analysis with SPSS 12 and 13: a guide for social scientists. New York, NY: Routledge; [13] Kundu SD, Roehl KA, Eggener SE, Antenor JA, Han M, Catalona WJ. Potency, continence and complications in 3,477 consecutive radical retropubic prostatectomies. J Urol 2004;172: [14] Lepor H, Nieder AM, Ferrandino MN. Intraoperative and postoperative complications of radical retropubic prostatectomy in a consecutive series of 1,000 cases. J Urol 2001;166: [15] Hisasue S, Takahashi A, Kato R, et al. Early and late complications of radical retropubic prostatectomy: experience in a single institution. Jpn J Clin Oncol 2004;34: [16] Augustin H, Hammerer P, Graefen M, et al. Intraoperative and perioperative morbidity of contemporary radical retropubic prostatectomy in a consecutive series of 1243 patients: results of a single center between 1999 and Eur Urol 2003;43: [17] Dillioglugil O, Leibman BD, Leibman NS, Kattan MW, Rosas AL, Scardino PT. Risk factors for complications and morbidity after radical retropubic prostatectomy. J Urol 1997;157: [18] Gheiler EL, Lovisolo JAJ, Tiguert R, et al. Results of a clinical care pathway for radical prostatectomy patients in an open hospital multiphysician system. Eur Urol 1999;35: [19] Davidson PJT, van den Ouden D, Schroeder FH. Radical prostatectomy: prospective assessment of mortality and morbidity. Eur Urol 1996;29: [20] Alibhai SM, Leach M, Tomlinson G, et al. 30-day mortality and major complications after radical prostatectomy: influence of age and comorbidity. J Natl Cancer Inst 2005;97: [21] Hautmann RE, Sauter TW, Wenderoth UK. Radical retropubic prostatectomy: morbidity and urinary continence in 418 consecutive cases. Urology 1994;43:47 51.

16 386 EUROPEAN UROLOGY 57 (2010) [22] Guillonneau B, Rozet F, Cathelineau X, et al. Perioperative complications of laparoscopic radical prostatectomy: the Montsouris 3-year experience. J Urol 2002;167:51 6. [23] Gregori A, Simonato A, Lissiani A, Bozzola A, Galli S, Gaboardi F. Laparoscopic radical prostatectomy: perioperative complications in an initial and consecutive series of 80 cases. Eur Urol 2003;44: [24] Hoznek A, Salomon L, Olsson LE, et al. Laparoscopic radical prostatectomy. The Créteil experience. Eur Urol 2001;40: [25] Rozet F, Galiano M, Cathelineau X, Barret E, Cathala N, Vallancien G. Extraperitoneal laparoscopic radical prostatectomy: a prospective evaluation of 600 cases. J Urol 2005;174: [26] Eden CG, Cahill D, Vass JA, Adams TH, Dauleh MI. Laparoscopic radical prostatectomy: the initial UK series. BJU Int 2002;90: [27] Gonzalgo ML, Pavlovich CP, Trock BJ, Link RE, Sullivan W, Su LM. Classification and trends of perioperative morbidities following laparoscopic radical prostatectomy. J Urol 2005;174: [28] Türk I, Deger S, Winkelmann B, Schönberger B, Loening SA. Laparoscopic radical prostatectomy. Technical aspects and experience with 125 cases. Eur Urol 2001;40: [29] Fischer B, Engel N, Fehr JL, John H. Complications of robotic assisted radical prostatectomy. World J Urol 2008;26: [30] Patel VR, Thaly R, Shah K. Robotic radical prostatectomy: outcomes of 500 cases. BJU Int 2007;99: [31] Krambeck AE, DiMarco DS, Rangel LJ, et al. Radical prostatectomy for prostatic adenocarcinoma: a matched comparison of open retropubic and robot-assisted techniques. BJU Int 2009;103: [32] Fenig DM, Slova D, Lepor H. Postoperative blood loss predicts the development of urinary extravasation on cystogram following radical retropubic prostatectomy. J Urol 2006;175: [33] Abe T, Shinohara N, Harabayashi T, et al. Postoperative inguinal hernia after radical prostatectomy for prostate cancer. Urology 2007;69: [34] Novara G, De Marco V, Aragona M, et al. Complications and mortality after radical cystectomy for bladder transitional cell cancer. J Urol 2009;182: [35] Shabsigh A, Korets R, Vora KC, et al. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol 2009;55: