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European Urology
Volume 57, issue 2, pages 179-362, February 2010Bladder Cancer
A Comparison of Postoperative Complications in Open versus Robotic Cystectomy
Casey K. Ng a, Eric C. Kauffman a, Ming-Ming Lee a, Brandon J. Otto a, Alyse Portnoff b, Josh R. Ehrlich a, Michael J. Schwartz a, Gerald J. Wang a, Douglas S. Scherr a 
.
Accepted 2 June 2009, Published online 10 June 2009, pages 274 - 282
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Abstract
Background
Robotic cystectomy is an emerging alternative for treatment of invasive bladder cancer (BCa). However, reduction in postoperative morbidity relative to the open approach has not been demonstrated.
Objective
To compare complication rates in patients undergoing robotic versus open radical cystectomy (RC).
Design, setting, and participants
A prospective cohort study of 187 consecutive patients undergoing RC at our institution—104 open RC, 83 robotic RC.
Intervention
Open or robotic RC with urinary diversion.
Measurements
Demographic, perioperative, and complication data were recorded prospectively. Thirty-day and 90-d complication rates were assessed using the modified Clavien complication scale. Data were evaluated using χ2 and multivariate logistic regression analyses.
Results and limitations
At 30 d, the open group demonstrated a higher overall complication rate (59% vs 41%; p = 0.04) as well as more major complications (30% vs 10%; p = 0.007). At 90 d, the overall complication rate was greater in the open group, but this was not statistically significant (62% vs 48%; p = 0.07). However, there was a significantly higher major complication rate in the open cohort (31% vs 17%; p = 0.03). When subjected to logistic regression analysis, robotic cystectomy was an independent predictor of fewer overall and major complications at 30 and 90 d. High American Society of Anesthesiologists (ASA) score (3–4) and longer surgical time were independent predictors of major complications. Though this is one of the largest published RC series, the sample size is relatively small. Moreover, despite the two patient cohorts being similarly matched, the study was not performed in a randomized fashion.
Conclusions
Patients undergoing robotic cystectomy experienced fewer postoperative complications than those undergoing open cystectomy. Robotic cystectomy is an independent predictor of fewer overall and major complications. Until long-term oncologic results are available, robotic cystectomy should still be considered investigational.
Keywords: Bladder cancer, Complication, Radical cystectomy, Robotics.
Article Outline
1. Introduction
Radical cystectomy (RC) has been shown to provide a long-term survival benefit in patients with muscle-invasive bladder cancer (BCa) [1]. Increasing use of orthotopic urinary diversion and cavernosal nerve-sparing techniques have improved functional and sexual outcomes. Recently, robotic RC has emerged as a minimally invasive treatment modality and has demonstrated significant improvements in intraoperative blood loss and length of stay (LOS) [2], [3], [4], [5], [6], [7], and [8]. Whether these improvements translate into a reduction in postoperative morbidity is not known [9], and [10]. Complication rates after RC have varied widely in the literature, ranging from 28% to 64% [1], and [11]. This variation is in part the result of a lack of a standardized system for reporting complications [12]. Some institutions have recently begun systematically recording complication data [11], and [13]. Using the modified Clavien classification of surgical complications, we report our 30- and 90-d complication rates after robotic RC and compare these outcomes with our concurrent series of open RCs. Using a multivariate logistic regression model, we then identify variables predictive of major and overall complications at both 30 and 90 d after RC.
2. Methods
From February 2002 to July 2008, 187 consecutive patients underwent RC by a single surgeon at our institution: 104 were performed open, 83 were robotic. This study was approved by the Institutional Review Board. Fifty-nine clinical and pathologic parameters were prospectively collected, including age, gender, body mass index (BMI), Charlson Age Comorbidity Index (CACI) score, American Society of Anesthesiologists (ASA) score, estimated blood loss (EBL), history of abdominal surgery, operative time (from skin opening to closing), LOS, pathologic stage, surgical margin status, and total number of lymph nodes removed. All complications within 90 d of surgery were recorded.
Open RC and pelvic lymphadenectomy (PLA) were performed in the standard fashion [14], and [15]. Robotic RC with pelvic lymph node dissection was performed as described previously [2]. With the extirpative portion of the procedure complete, urinary diversion was performed extracorporeally through a 5–7 cm incision extended from the periumbilical port site. For orthotopic neobladders, the robot was redocked for the urethral neovesical anastomosis. PLA was performed with borders extending from the upper common iliac artery superiorly, Cooper's ligament (including the node of Cloquet) inferiorly, the genitofemoral nerve laterally, and the sacral promontory medially. Identical perioperative clinical pathways, including but not limited to preoperative bowel preparation and antibiotics, perioperative deep vein thrombosis prophylaxis, and criteria to resume diet, were implemented for both open and robotic RC.
Thirty-day and 90-d complications were collected prospectively. Correspondence with patients and their physicians ensured that treatment received outside of our institution was accounted for in our database. All complications were graded using the modified Clavien system [16] and were additionally classified by organ system. Grade 1 and 2 complications were classified as minor, and grades 3–5 were classified as major (Table 1).
Table 1 Modified Clavien classification of surgical complications
| Grade | Definition |
|---|---|
| Grade I | Any deviation from the normal postoperative course without the need for pharmacologic treatment or surgical, endoscopic, and radiologic interventions (allowed therapeutic regimens: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy; grade also includes wound infections opened at the bedside) |
| Grade II | Requiring pharmacologic treatment with drugs other than such allowed for grade I complications (blood transfusions and total parenteral nutrition also included) |
| Grade III | Requiring surgical, endoscopic, or radiologic intervention |
| Grade IIIa | Intervention not under general anesthesia |
| Grade IIIb | Intervention under general anesthesia |
| Grade IV | Life-threatening complication requiring ICU management |
| Grade V | Death of a patient |
ICU = intensive care unit.
Statistical analysis was performed using χ2 and 2-tailed student t tests to compare perioperative and pathologic characteristics between the two cohorts. Univariate and multivariate logistic regression analyses were performed to identify variables predictive of both overall and major complications. Variables that were analyzed included EBL, the use of robotic cystectomy (vs open cystectomy), ileal conduit (vs continent diversion), ASA ≥3, CACI score ≥3, age, operative time, and pathologic stage of pT2 or lower (vs pathologic stage greater than pT2). EBL, age, and operative time were evaluated as continuous variables. EBL and robotic cystectomy were identified as covariants as evidenced by the high ρ value based on Spearman rank correlation. Therefore, it was statistically necessary to evaluate EBL separately. Statistical analyses were performed using Statistical Package for the Social Sciences 16.0 (SPSS, Chicago, IL, USA).
3. Results
3.1. Patient characteristics
Demographic parameters are shown in Table 2. Of the 83 robotic cystectomy patients, 77 patients had follow-up extending beyond 90 d. There was no difference in the mean BMI, ASA score, and CACI score between the two cohorts. In the open cohort, 49% of patients received an ileal conduit, 22% an Indiana pouch, and 28% an orthotopic neobladder. Urinary diversion was not performed in one patient with end-stage renal disease on hemodialysis. In the robotic cohort, ileal conduit was performed in 57% of patients, Indiana pouch in 12%, and orthotopic neobladder in 31%. There was no statistically significant difference in the distribution of urinary diversions between the two cohorts.
Table 2 Patient demographics
| Open | Robotic | p value | |
|---|---|---|---|
| Patients, no. | 104 | 83 | – |
| Male | 73 | 65 | – |
| Female | 31 | 18 | – |
| Mean age, yr (±SD) | 67.2 (±10.6) | 70.9 (±10.8) | 0.02 |
| Mean BMI, kg/m2 (±SD) | 27.2 (±6.0) | 26.3 (±3.9) | 0.23 |
| Patients with ASA score 1–2, no. (%) | 54 (51.9) | 47 (56.6) | 0.21 |
| Patients with CACI ≤2, no. (%) | 72 (69.2) | 49 (59.0) | 0.17 |
| Patients with previous abdominal surgery, no. (%) | 42 (40.4) | 30 (36.1) | 0.65 |
| Ileal conduit, no. (%) | 51 (49.0) | 47 (56.6) | 0.31 |
| Indiana pouch, no. (%) | 23 (22.1) | 10 (12.0) | – |
| Neobladder, no. (%) | 29 (27.9) | 26 (31.3) | – |
| None, no. (%) | 1 (1.0) | 0 (0) | – |
SD = standard deviation; BMI = body mass index; ASA = American Society of Anesthesiologists; CACI = Charlson Age Comorbidity Index.
3.2. Perioperative and pathologic data
Mean operative time (Table 3) was 18 min longer in the robotic group, but this was not statistically significant (6.25 vs 5.95 h; p = 0.3). The robotic cohort demonstrated decreased blood loss (460 vs 1172 ml; p < 0.001) and transfusion requirement (1.42 vs 3.65 units; p < 0.0001). Median LOS was shorter in the robotic cohort (5.5 vs 8.0 d; p < 0.0001). There was no difference in distribution of pathologic stages between the two groups. There was an equivalent rate of extravesical disease in the open and robotic groups (42% and 39%; p = 0.6). Median lymph node yield (open: 15; robotic: 16; p = 0.23) and the rate of positive margins (open: 9%; robotic: 7%; p = 0.8) were similar in both groups. Two patients in the open cohort and one patient in the robotic cohort had palliative cystectomies for intractable hematuria and therefore did not have lymph nodes removed. In both groups, all patients with positive margins had either pT3 or pT4 disease.
Table 3 Perioperative and pathologic data
| Open | Robotic | p value | |
|---|---|---|---|
| Mean operative time, h (±SD) | 5.95 (±2.2) | 6.25 (±1.5) | 0.29 |
| Mean EBL, ml (±SD) | 1172 (±916) | 460 (±299) | <0.0001 |
| Mean PRBC transfused, units (±SD) | 3.65 (±3.9) | 1.42 (±1.6) | <0.0001 |
| Median LOS, d (range) | 8 (3–60) | 5.5 (3–28) | <0.0001 |
| T0, no. (%) | 16 (15.4) | 12 (14.5) | – |
| Ta, no. (%) | 4 (3.8) | 8 (9.6) | – |
| Tis, no. (%) | 10 (9.6) | 9 (10.8) | – |
| T1, no. (%) | 15 (14.4) | 11 (13.3) | – |
| T2, no. (%) | 15 (14.4) | 11(13.3) | – |
| T3, no. (%) | 22 (21.2) | 23 (27.7) | – |
| T4, no. (%) | 22 (21.2) | 9 (10.8) | – |
| Organ confined (≤pT2), no. (%) | 60 (57.7) | 51 (61.4) | 0.61 |
| Non-organ confined (pT3–4), no. (%) | 44 (42.3) | 32 (38.6) | – |
| N0, no. (%) | 80 (76.9) | 70 (84.3) | 0.04 |
| N1 + , no. (%) | 24 (23.1) | 13 (15.7) | – |
| Mean nodes removed (±SD) | 15.7 (±13.2) | 17.9 (±10.4) | 0.23 |
| Median nodes removed (range) | 15 (0–69) | 16 (0–56) | – |
| PSM | 9 (8.7%) | 6 (7.2%) | 0.77 |
SD = standard deviation; EBL = estimated blood loss; PRBC = packaged red blood cells; LOS = length of stay; PSM = positive surgical margins.
3.3. Complications and readmission
As shown in Table 4, the overall complication rate at 30 d was higher in the open group (58.7% vs 41.0%; p = 0.04). When grouped into minor or major complications, 29.8% of open cystectomy patients had major complications compared to 9.6% of robotic cystectomy patients (p = 0.007). At 90 d, the overall complication rate was also greater in the open group, but this was not statistically significant (61.5% vs 48.1%; p = 0.07). However, when grouped into minor or major complications, there were more patients with major complications in the open versus robotic group (30.8% vs 16.9%; p = 0.03). As shown in Table 5, infectious disease complications were most common, followed by gastrointestinal and cardiac complications. We did not observe any significant differences in the types of complications between the open and robotic cohort, except for reduced frequency of pulmonary complications in the robotic cohort at 30 d. The majority of all complications were minor. At 30 d, 71.0% and 83.6% of all complications were minor in the open and robotic cohorts, respectively. At 90 d, 71.8% and 75.9% of all complications were minor in the open and robotic cohorts, respectively. Between 30 and 90 d, there were eight and nine additional major complications in the open and robotic cohort, respectively. In terms of emergency room visits and readmission to the hospital, we did not find any significant differences between the open and robotic cohorts.
Table 4 Patients with complications
| 30 d | 90 d | |||||
|---|---|---|---|---|---|---|
| Open | Robotic | p value | Open | Robotic | p value | |
| Patients, no. | 104 | 83 | – | 104 | 77 | – |
| Patients with complications, no. (%) | 61 (58.7) | 34 (41.0) | 0.04 | 64 (61.5) | 37 (48.1) | 0.07 |
| Patients with major complications, no. (%) | 31 (29.8) | 8 (9.6) | 0.007 | 32 (30.8) | 13 (16.9) | 0.03 |
| Highest grade of complication | ||||||
| Grade 0, no. (%) | 43 (41.3) | 49 (59.0) | – | 40 (38.5) | 41 (53.2) | – |
| Grade 1, no. (%) | 7 (6.7) | 10 (12.0) | – | 8 (7.7) | 10 (13.0) | – |
| Grade 2, no. (%) | 23 (22.1) | 16 (19.3) | – | 24 (23.1) | 13 (16.9) | – |
| Grade 3a, no. (%) | 13 (12.5) | 7 (8.4) | – | 15 (14.4) | 8 (10.4) | – |
| Grade 3b, no. (%) | 7 (6.7) | 0 (0) | – | 5 (4.8) | 4 (5.2) | – |
| Grade 4, no. (%) | 6 (5.8) | 1 (1.2) | – | 6 (5.8) | 1 (1.3) | – |
| Grade 5, no. (%) | 5 (4.8) | 0 (0) | – | 6 (5.8) | 0 (0) | – |
Table 5 Thirty- and 90-day complication details
| 30 d | 90 d | |||||
|---|---|---|---|---|---|---|
| Open | Robotic | p value | Open | Robotic | p value | |
| Patients, no. | 104 | 83 | – | 104 | 77 | – |
| Complications, no. | 161 | 55 | – | 201 | 81 | – |
| Types of complications: | ||||||
| 1: Surgical, no. (%) | 0 (0) | 0 (0) | – | 0 (0) | 0 (0) | – |
| 2: Wound, no. (%) | 14 (8.7) | 5 (9.1) | 1.0 | 16 (8.0) | 5 (6.5) | 0.8 |
| Cellulitis | 9 | 4 | 11 | 4 | ||
| Dehiscence | 5 | 1 | 5 | 1 | ||
| 3: Pulmonary, no. (%) | 14 (8.7) | 0 (0) | 0.023 | 14 (7.0) | 1 (1.2) | 0.07 |
| Respiratory failure | 6 | 0 | 6 | 0 | ||
| Pneumonia | 7 | 0 | 7 | 1 | ||
| Pneumothorax | 1 | 0 | 1 | 0 | ||
| 4: Neurologic, no. (%) | 5 (3.1) | 0 (0) | 0.33 | 5 (2.5) | 0 (0) | 0.32 |
| Encephalopathy | 1 | 0 | 1 | 0 | ||
| CVA | 4 | 0 | 4 | 0 | ||
| 5: Gastrourinary, no. (%) | 10 (6.2) | 4 (7.3) | 0.76 | 14 (7.0) | 10 (12.3) | 0.15 |
| Renal failure | 7 | 2 | 9 | 4 | ||
| Ureteral obstruction | 1 | 2 | 2 | 3 | ||
| Urinary fistula | 1 | 0 | 2 | 1 | ||
| Urinary leak | 1 | 0 | 1 | 2 | ||
| 6: ID, no. (%) | 39 (24.2) | 17 (30.9) | 0.37 | 64 (31.8) | 26 (32.1) | 1.0 |
| Fever of unknown origin | 3 | 2 | 5 | 1 | ||
| UTI | 9 | 8 | 17 | 14 | ||
| Intra-abdominal abscess | 11 | 4 | 20 | 5 | ||
| Bacteremia/septicemia | 1 | 2 | 3 | 2 | ||
| Sepsis | 12 | 0 | 15 | 2 | ||
| Parotitis | 1 | 0 | 1 | 0 | ||
| Pyelonephrisits | 2 | 1 | 2 | 1 | ||
| Fungemia | 0 | 0 | 1 | 1 | ||
| 7: GI, no. (%) | 36 (22.4) | 17 (30.9) | 0.21 | 40 (19.9) | 22 (27.2) | 0.20 |
| Ileus* | 18 | 12 | 21 | 13 | ||
| SBO | 3 | 1 | 3 | 3 | ||
| Clostridium difficile colitis | 4 | 3 | 5 | 2 | ||
| Hematemesis | 0 | 1 | 0 | 1 | ||
| Duodenal erythema | 1 | 0 | 1 | 0 | ||
| Failure to take PO/malnutrition | 2 | 0 | 2 | 0 | ||
| GI bleeding | 2 | 0 | 2 | 1 | ||
| Ascites | 3 | 0 | 3 | 0 | ||
| Small bowel leak | 2 | 0 | 2 | 0 | ||
| Enterocutaneous fistula | 1 | 0 | 1 | 1 | ||
| Esophageal cadidiasis | 0 | 0 | 0 | 1 | ||
| 8: Cardiac, no. (%) | 20 (12.4) | 6 (10.9) | 1.0 | 20 (10.0) | 9 (11.1) | 0.83 |
| Atrial fibrillation | 6 | 4 | 6 | 4 | ||
| SVT | 2 | 1 | 2 | 1 | ||
| MI | 6 | 1 | 6 | 1 | ||
| Cardiac arrest | 3 | 0 | 3 | 0 | ||
| BBB | 1 | 0 | 1 | 0 | ||
| Endocarditis | 1 | 0 | 1 | 0 | ||
| CHF | 1 | 0 | 1 | 0 | ||
| 9: Bleeding, no. (%) | 4 (2.5) | 0 (0) | 0.57 | 5 (2.5) | 1 (1.2) | 0.68 |
| Significant transfusion | 2 | 0 | 3 | 1 | ||
| Hematoma | 2 | 0 | 2 | 0 | ||
| 10: Miscellaneous, no. (%) | 13 (8.1) | 2 (3.6) | 0.36 | 16 (8.0) | 2 (2.5) | 0.11 |
| Rash | 0 | 1 | 1 | 1 | ||
| Delirium | 1 | 0 | 1 | 0 | ||
| Depression/confusion | 1 | 0 | 1 | 0 | ||
| Suicidal incident | 1 | 0 | 1 | 0 | ||
| Failure to thrive | 5 | 0 | 6 | 0 | ||
| Dehydration | 2 | 1 | 3 | 1 | ||
| Death | 2 | 0 | 2 | 0 | ||
| Gout | 1 | 0 | 1 | 0 | ||
| 11: Thromboembolic, no. (%) | 6 (3.7) | 4 (7.3) | 0.28 | 7 (3.5) | 6 (7.4) | 0.21 |
| DVT | 4 | 3 | 4 | 5 | ||
| PE | 2 | 1 | 3 | 2 | ||
| Grade of complication, no. (%) | ||||||
| 1 | 35 (21.7) | 22 (40) | – | 53 (26.4) | 28 (34.6) | – |
| 2 | 80 (49.7) | 24 (43.6) | – | 94 (46.8) | 35 (43.2) | – |
| 3a | 23 (14.3) | 8 (14.5) | – | 29 (14.4) | 13 (16.0) | – |
| 3b | 10 (6.2) | 0 (0) | – | 11 (5.5) | 4 (4.9) | – |
| 4 | 8 (5.0) | 1 (1.8) | – | 8 (4.0) | 1 (1.2) | – |
| 5 | 5 (3.1) | 0 (0) | – | 6 (3.0) | 0 (0) | – |
CVA = cerebrovascular accident; ID = infectious disease; UTI = urinary tract infection; GI = gastrointestinal; SBO = small bowel obstruction; PO = per os (by mouth); SVT = supraventricular tachycardia; MI = myocardial infarction; BBB = bundle branch block; CHF = congestive heart failure; DVT = deep vein thrombosis; PE = pulmonary embolism.
*
3.4. Predictors of no complications or minor complications
Using univariate analysis to evaluate EBL, robotic cystectomy, type of urinary diversion, ASA score, CACI score, age, operative time, and tumor stage, we found that robotic cystectomy was inversely correlated, while EBL and the ASA score were directly correlated with overall complications at 30 d (Table 6). With regard to major complications, robotic cystectomy was again inversely correlated, while EBL, ASA score, and CACI were directly correlated at 30 d. At 90 d, EBL, ASA score and Charlson index were directly correlated with overall complications. Robotic cystectomy was inversely correlated, while EBL, the use of ileal conduit, ASA score, and non–organ-confined disease were directly correlated with major complications at 90 d. When subjected to multivariate analysis, robotic cystectomy was predictive of fewer overall and major complications at 30 and 90 d. ASA score and prolonged operative time were predictive of major complications at 30 d. ASA score, use of ileal conduit, and longer operative time were predictive of major complications at 90 d.
Table 6 Predictors of complications: univariate and multivariate analysis
| 30-d overall complications univariate | 30-d overall complications multivariate | |||
|---|---|---|---|---|
| OR (95% CI) | p value | OR (95% CI) | p value | |
| EBL | 1.001 (1.000–1.001) | 0.003 | – | – |
| Robotic RC (vs open RC) | 0.550 (0.307–0.987) | 0.045 | 0.505 (0.270–0.943) | 0.032 |
| Ileal conduit (vs continent diversion) | 0.941 (0.530–1.672) | 0.836 | 0.795 (0.357–1.770) | 0.575 |
| ASA ≥3 (vs ASA ≤2) | 1.627 (1.020–2.595) | 0.041 | 1.505 (0.902–2.511) | 0.118 |
| CACI ≥3 (vs CACI ≤2) | 1.135 (0.996–1.293) | 0.058 | 1.114 (0.966–1.285) | 0.137 |
| Age | 1.004 (0.978–1.031) | 0.771 | 1.011 (0.978–1.046) | 0.522 |
| Operative time | 1.036 (0.890–1.205) | 0.648 | 1.086 (0.888–1.328) | 0.420 |
| Non–organ confined (vs organ confined) | 1.170 (0.657–2.083) | 0.908 | 0.908 (0.486–1.700) | 0.764 |
| 30-d major complications univariate | 30-d severe complications multivariate | |||
|---|---|---|---|---|
| OR (95% CI) | p value | OR (95% CI) | p value | |
| EBL | 1.001 (1.000–1.001) | 0.001 | – | – |
| Robotic RC (vs open RC) | 0.337 (0.143–0.794) | 0.013 | 0.294 (0.113–0.761) | 0.012 |
| Ileal conduit (vs continent diversion) | 1.705 (0.784–3.706) | 0.178 | 2.533 (0.850–7.548) | 0.095 |
| ASA ≥3 (vs ASA ≤2) | 2.801 (1.461–5.371) | 0.002 | 2.478 (1.181–5.197) | 0.016 |
| CACI ≥3 (vs CACI ≤2) | 1.170 (1.010–1.355) | 0.036 | 1.100 (0.923–1.312) | 0.288 |
| Age | 0.994 (0.960–1.029) | 0.730 | 0.996 (0.954–1.040) | 0.860 |
| Operative time | 1.082 (0.888–1.318) | 0.433 | 1.334 (1.029–1.730) | 0.030 |
| Non–organ confined (vs organ confined) | 1.161 (0.543–2.481) | 0.700 | 0.918 (0.467–1.974) | 0.803 |
| 90-d overall complications univariate | 90-d overall complications multivariate | |||
|---|---|---|---|---|
| OR (95% CI) | p value | OR (95% CI) | p value | |
| EBL | 1.001 (1.000–1.001) | 0.005 | – | – |
| Robotic RC (vs open RC) | 0.578 (0.318–1.050) | 0.072 | 0.481 (0.250–0.924) | 0.028 |
| Ileal conduit (vs continent diversion) | 1.295 (0.719–2.334) | 0.389 | 1.333 (0.592–3.001) | 0.487 |
| ASA ≥3 (vs ASA ≤2) | 1.922 (1.175–3.143) | 0.009 | 1.642 (0.962–2.803) | 0.069 |
| CACI ≥3 (vs CACI ≤2) | 1.196 (1.034–1.382) | 0.016 | 1.145 (0.977–1.342) | 0.095 |
| Age | 1.011 (0.984–1.039) | 0.415 | 1.011 (0.977–1.046) | 0.544 |
| Operative time | 1.020 (0.876–1.188) | 0.799 | 1.180 (0.957–1.456) | 0.121 |
| Non–organ confined (vs organ confined) | 1.339 (0.736–2.438) | 0.339 | 0.814 (0.429–1.546) | 0.530 |
| 90-d major complications univariate | 90-d severe complications multivariate | |||
|---|---|---|---|---|
| OR (95% CI) | p value | OR (95% CI) | p value | |
| EBL | 1.001 (1.000–1.001) | 0.003 | – | – |
| Robotic RC (vs open RC) | 0.500 (0.245–0.995) | 0.049 | 0.423 (0.185–0.967) | 0.041 |
| Ileal conduit (vs continent diversion) | 2.161 (1.070–4.363) | 0.032 | 3.522 (1.321–9.386) | 0.012 |
| ASA ≥3 (vs ASA ≤2) | 2.926 (1.618–5.292) | <0.001 | 3.087 (1.501–6.348) | 0.002 |
| CACI ≥3 (vs CACI ≤2) | 1.158 (1.009–1.329) | 0.037 | 1.032 (0.871–1.223) | 0.718 |
| Age | 1.003 (0.972–1.034) | 0.859 | 0.990 (0.952–1.030) | 0.625 |
| Operative time | 1.043 (0.877–1.240) | 0.635 | 1.384 (1.084–1.757) | 0.009 |
| Non–organ confined (vs organ confined) | 2.024 (1.028–3.984) | 0.041 | 0.497 (0.232–1.063) | 0.071 |
OR = odds ratio; CI = confidence interval; EBL = estimated blood loss; RC = radical cystectomy; ASA = American Society of Anesthesiologists; CACI = Charlson Age Comorbidity Index.
4. Discussion
To our knowledge, this study represents the largest comparative series of complications between open and robotic RC. Despite having long-term oncologic success, open RC with lymph node dissection remains a morbid procedure. Recent studies have shown that the complication rate after cystectomy may be higher than the previously reported rates of 28–39% [1], [17], [18], [19], [20], and [21]. Lowrance et al reported a 30-d postoperative complication rate of 41% [22], and Shabsigh et al reported a 90-d postoperative complication rate of 64% [11]. These higher complication rates can be attributed to the more recent use of systemic classification criteria and a more thorough inclusion of minor complications (eg, use of oral antibiotics for superficial wound infection). As suggested by Donat [12], improving patient outcomes and surgical technique first requires an accurate characterization of all postoperative complications. In this study, we attempted to perform a comprehensive and meticulous review of all complications after RC using the modified Clavien system, a methodology that is simple, comprehensive, and reproducible [16].
To date, a number of reports on robotic cystectomy have documented improved perioperative outcomes compared to the open approach [2], [3], [4], [5], [6], and [7]. However, these studies have been criticized for selecting patients who are younger, have fewer comorbid conditions, and are less likely to have had prior abdominal surgery [9], and [10]. The earliest reports of robotic cystectomy indeed demonstrated a selection bias for healthier patients and a lower disease burden, which is to be expected to determine feasibility when any new surgical approach is introduced. Accordingly, our initial published experience with robotic cystectomy demonstrated a higher proportion of patients with pathologically organ-confined disease in the robotic cohort [2]. However, as our experience with robotic cystectomy increased, we have become more comfortable treating patients with advanced disease and comorbid conditions. In the current study, there was no difference between the robotic and open cohorts with regard to BMI, ASA score, CACI score, history of previous abdominal surgery, and proportion of pathologically organ-confined disease. Patients who underwent robotic cystectomy lost less blood, were less likely to be transfused, and were discharged from the hospital earlier than patients who underwent open cystectomy.
Moreover, our findings demonstrate that the robotic cohort had fewer complications than the open cohort (Table 4). At both 30 and 90 d, the overall and major complication rates were greater in the open group. Although the trend toward a lower overall complication rate at 90 d in the robotic cohort was not statistically significant, this finding may be to the result of the limited sample size. Furthermore, we found that on multivariate analysis, the robotic approach is an independent predictor for fewer complications. Additional predictors for complications included ASA score, operative time, and diversion type. Our finding with regard to ASA score is consistent with previously published studies [11], [23], [24], and [25]. The finding that ileal conduit diversion was associated with more major complications at 90 d is possibly to the result of patient selection, as patients with more comorbidities and lower performance status were more likely to receive ileal conduit diversion.
With regard to complication type, our results are similar to the findings of Shabsigh et al. [11]. The most common complications were infectious, followed by gastrointestinal and cardiac (Table 5). Although there were fewer complications in the robotic cohort, types of complications were similar between the two groups, except for fewer 30-d pulmonary complications in the robotic cohort. A possible reason for this observation is reduced pain from robotic cystectomy, which could promote earlier pulmonary rehabilitation. Thromboembolic complications were higher in the robotic cohort. However, the difference was not statistically significant, and similarly high incidence has been previously reported for open RC [11].
Our 30-d major complication rate of 29.8% in the open cohort is higher than the 12% rate reported by Shabsigh et al. [11]. The reason for this discrepancy is not entirely clear. It may be to the result of differences between our pathway managements. For example, we do not routinely administer postoperative antibiotics after cystectomy, and the majority of our 30-d major complications in the open cohort were percutaneous drains placed for postoperative fluid collection. Nevertheless, to our knowledge, the report by Shabsigh et al and the present study represent the only two contemporary reports of postcystectomy complications using a standardized classification scheme. It is therefore possible that our combined data may simply represent the range of major complications after RC at 30 d.
The etiology of the lower complication rate in the robotic cystectomy cohort may be related to lower EBL. Previous studies have demonstrated that EBL and transfusion requirements are highly correlated with complications [20], and [23]. Chang et al and Boström et al found that high EBL and transfusion requirements were associated with ileus and other minor complications. In our study, robotic cystectomy was highly correlated with lower EBL (Spearman rank correlation: ρ = 0.65). The role EBL plays in postcystectomy complications is likely multifactorial. In a direct sense, greater intraoperative blood loss may itself be deleterious in the typical patient undergoing RC who has numerous medical comorbidities and is therefore less able to tolerate significant blood loss and fluid shifts. Indirectly, however, EBL may also be a surrogate for the degree of difficulty of each individual case, the extent of disease, and numerous other factors that are difficult to capture. Even though pathologic stage was not significantly different between the two groups, these confounding factors can only be definitively addressed by a randomized study. Additional factors associated with minimally invasive surgery, which may play a role in postoperative complications, include diminished insensible fluid loss, decreased operative manipulation, and reduced surgeon fatigue. However, these factors are difficult to quantify, and their relative contributions remain unknown.
Open RC remains the gold standard for treatment of invasive BCa, and the ultimate oncologic safety of robotic cystectomy is not yet clear. Until long-term oncologic follow-up is available, we will have to rely on pathologic parameters of short-term oncologic efficacy, such as lymph node yield and margin status. The lymph node yield from our robotic group was equivalent to that found in our open cohort (Table 3). We routinely begin our lymph node dissection at the upper portion of the common iliac vessels and are able to reach the aortic bifurcation when necessary. With regard to surgical margins, positive margin rates were similar in both cohorts and within the acceptable range, given that all occurred in pT3 or pT4 specimens and the majority of these patients had node-positive disease. At this time, short-term oncologic follow-up with a median of 14 mo reveals no significant differences in recurrence-free, disease-specific, and overall survival. Additional concerns regarding robotic cystectomy are the theoretical risk of port site metastasis and the potential effect of pneumoperitoneum on tumor spread. Early reports of port site metastasis of transitional cell carcinoma involved specimen retrieval without an extraction bag or with a bag that was torn [26]. Despite reports by El Tabey [27] and Tanaka [28], we have not observed port site metastases in our cohort of robotic cystectomy patients.
There are several limitations to this study. First, although our study represents one of the larger robotic cystectomy series published, a sample size of 87 patients remains small compared to those reported in open series. Second, although the modified Clavien system is well recognized in the general surgery community, its reproducibility and acceptability have yet to be determined in the urologic community. Finally, although both cohorts appear to be matched in terms of comorbidities and pathologic characteristics, this is not a randomized study and is therefore subject to the numerous biases therein.
5. Conclusions
This study demonstrates that robotic cystectomy appears to be a feasible treatment option for patients with invasive BCa and that the robotic approach may provide benefits to patients by reducing the number and severity of complications. However, robotic cystectomy should still be considered experimental until long-term follow-up is available to establish oncologic equivalence with open RC. Additionally, systematic reporting of complications is required and will allow us to further investigate areas where we can improve the quality of care provided to patients with invasive BCa. We believe that this study further supports the need for a randomized trial comparing open and robotic RC.
Author contributions: Douglas S. Scherr 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: Ng, Scherr.
Acquisition of data: Lee, Otto, Ehrlich.
Analysis and interpretation of data: Kauffman, Portnoff.
Drafting of the manuscript: Ng, Kauffman.
Critical revision of the manuscript for important intellectual content: Ng, Schwartz, Wang.
Statistical analysis: Portnoff, Ng.
Obtaining funding: none.
Administrative, technical, or material support: Lee.
Supervision: Scherr.
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: none.
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Footnotes
a Weill Cornell Medical College, Department of Urology, New York, NY, USA
b Cornell University, Department of Biomechanical Engineering, Ithaca, NY, USA
Corresponding author at: Department of Urology, 525 E. 68th Street, Starr 900, New York, NY 10065, USA. Tel. +212 746 5788.
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