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Impact of Robotic Radical Cystectomy on Urinary Diversion

By: Jacob E. Tallman, MD, Vanderbilt University Medical Center, Nashville, Tennessee; Amy N. Luckenbaugh, MD, Vanderbilt University Medical Center, Nashville, Tennessee | Posted on: 04 May 2023

Introduction

Radical cystectomy with urinary diversion remains the gold standard treatment for patients with localized muscle-invasive bladder cancer and is often performed for those with bacillus Calmette-Guérin-refractory nonmuscle-invasive bladder cancer. The robotic-assisted approach (RARC) has promised improvements in open radical cystectomy (ORC) complication rates, though many purported benefits lack supporting evidence. Here we review the impact of RARC on urinary diversion for radical cystectomy.

Current Evidence: Extracorporeal Diversion

There have been 4 randomized trials to date which have evaluated RARC vs ORC (see Table). The first 2 published trials utilized exclusively extracorporeal urinary diversion (EUD), whereby an open incision was made for urinary reconstruction after the extirpative portion of the case was completed robotically.

Table. Summary of Key Randomized Trials Evaluating Robotic Cystectomy

Trial author (year) Design and population Intervention and outcomes Key findings
Bochner et al1
(2015)
Single-center randomized trial
118 patients with Ta-T3/N0-3/M0 bladder cancer
1:1 Randomization to RARC with EUD vs ORC
Primary outcome: 90-d Clavien-Dindo grade 2-5 complications
Secondary outcomes: high-grade complications, EBL, operative time, pathological outcomes, 3- and 6-mo patient-reported QOL, and total costs
– No difference in overall complication rate, decrease in wound complications robotic (14% ORC vs 3% RARC, P = .041)
– Less operative time open (329 min ORC vs 456 min RARC, P < .001)
– Less blood loss robotic (676 mL ORC vs 515 mL RARC, P = .027)
– No difference in patient-reported QOL
Parekh et al2 (2018) Multicenter, phase 3, randomized noninferiority trial
350 patients with T1-T4/N0-N1/M0 bladder cancer
1:1 Randomization to RARC with EUD vs ORC
Primary outcome: 2-y progression-free survival
Secondary outcomes: EBL, blood transfusion, surgical margins, No. lymph nodes resected, operative time, length of hospital stay, 90-d complications, health-related QOL at 3 and 6 mo
– RARC noninferior for 2-y PFS (RARC 72.3% vs ORC 71.6%, Pnoninferiority = .001)
– RARC decreased EBL (300 vs 700 mL, P < .0001) and decreased hospital LOS (6 vs 7 d, P = .02)
– ORC less operative time (428 vs 361 min, P = .0005)
– No differences in patient-reported QOL
– No difference in adverse events (RARC 67% vs ORC 69%, P = .75)
Mastroianni et al3
(2022)
Single-center randomized trial
116 patients with T2-4/N0/M0 or recurrent bacillus Calmette-Guérin-refractory NMIBC
1:1 Randomization to RARC with IUD vs ORC
Primary outcome: overall perioperative transfusion rate
Secondary outcomes: LOS, 30-, 90-, and 180-d complications, global costs, and 6-mo functional, oncologic, and QOL outcomes
– RARC with IUD had lower transfusion rate (22% RARC vs 41% ORC; P = .046) and lower EBL (RARC 401 mL vs ORC 467 mL; P = .02)
– RARC with IUD longer operative time (313 min vs 190 min; P < .001)
– RARC higher cost (€31,886 vs €20,102; P < .001)
– No significant differences in perioperative complications, LOS, or 6-mo QOL
Catto et al4
(2022)
Multicenter, phase 3, randomized trial
338 patients with Ta-T4/N0-N1/M0 bladder cancer
1:1 Randomization to RARC with IUD vs ORC
Primary outcome: days alive and out of hospital within 90 d of surgery
20 Secondary outcomes including: 90-d complications, overall survival, oncologic outcomes, and health-related QOL outcomes
– RARC with IUD associated with 2 more d alive and out of hospital at 90 d (82 vs 80, P = .01), decreased LOS (7 vs 8 d, P = .05), and decreased readmission rate (21.8% vs 32.2%, P = .04)
– RARC decreased wound (5.6% vs 17.3%) and thromboembolic (1.9% vs 8.3%) complications
– Some marginal early differences in QOL, physical activity, strength/stamina; no longer significant at 12 wk
– No significant difference in recurrences or overall survival
– RARC decreased EBL (200 mL vs 550 mL; difference 95% CI, –275.7 to –424.3) but no difference in transfusions
Abbreviations: EBL, estimated blood loss; EUD, extracorporeal urinary diversion; IUD, intracorporeal urinary diversion; LOS, length of stay; NMIBC, nonmuscle-invasive bladder cancer; ORC, open radical cystectomy; PFS, progression-free survival; QOL, quality of life; RARC, robotic-assisted radical cystectomy.

Bochner et al from Memorial Sloan Kettering Cancer Center (MSKCC) published their single-center randomized trial of 118 patients in 2015, providing some of the earliest level 1 evidence comparing ORC and RARC with EUD.1 There was significantly less operative time with the open approach (329 minutes ORC vs 456 minutes RARC, P < .001) but less blood loss robotically (676 mL ORC vs 515 mL RARC, P = .027). There were no differences in patient-reported quality of life outcomes at any time point, and while there was a decrease in wound complications (14% ORC vs 3% RARC, P = .041), there was no difference in overall complication rates. The authors concluded that RARC failed to demonstrate the large benefit promised by prior early reports.

RAZOR was a multicenter, randomized noninferiority trial comparing ORC vs RARC with EUD.2 Among 302 randomized patients, there was no significant difference in 2-year progression-free survival (RARC 72.3% vs ORC 71.6%, HR 0.94, 95% CI 0.63-1.39) or adverse events (RARC 67% vs ORC 69%, P = .75), indicating noninferiority of RARC. The trial did demonstrate some advantages to RARC including decreased blood loss (300 vs 700 mL, P < .0001) and a small decrease in hospital length of stay (6 vs 7 days, P = .02). ORC was associated with significantly less operative time (428 vs 361 minutes, P = .0005).

While the RAZOR and MSKCC trials were some of the first to demonstrate comparable oncologic outcomes and noninferiority of RARC, a key limitation to both trials was the exclusive use of EUD for reconstruction instead of intracorporeal urinary diversion (IUD), which many have argued limits the potential benefits of the robotic approach. In this context, further trials were designed to evaluate RARC with IUD.

Current Evidence: Intracorporeal Diversion

In 2022, Mastroianni et al published their single-center randomized trial of 116 patients comparing RARC with IUD vs ORC.3 The only significant differences noted by the authors were decreased blood loss and transfusion rate for the robotic approach (EBL 401 mL vs 467 mL, P = .02; transfusion rate 22% vs 41%, P = .046) and a shorter operative time open (190 vs 313 minutes, P < .001). While limited by sample size and its single-center nature, this study provides evidence consistent with previous trials utilizing EUD.

The iROC trial was a multicenter randomized trial comparing RARC with IUD and ORC in 317 patients.4 For the primary outcome, days alive and out of the hospital at 90 days, RARC demonstrated an advantage of 2 days (82 vs 80 days, P = .01). RARC patients had a decreased length of hospital stay (7 vs 8 days, P = .05), readmission rate (21.8% vs 32.2%, P = .04), wound (5.6% vs 17.3%; difference [95% CI]: –11.7 [–18.6 to –4.6]), and thromboembolic (1.9% vs 8.3%, difference [95% CI]: –6.5 [–11.4 to –1.4]) complications. Among multiple other secondary outcomes, there were some marginal improvements noted for RARC, many of which disappeared by 12 weeks. The clinical significance of the highlighted differences in this trial remains uncertain. A limited number of high-volume centers have adopted IUD in virtually all RARC cases,5 but there remains significant variability in surgical approach (EUD vs IUD) and diversion type across the country, and there is no level 1 evidence directly comparing EUD and IUD.6

Long-term Functional Outcomes

Most of the randomized trials evaluating RARC are lacking in long-term follow-up data to evaluate functional outcomes including ureteroenteric anastomotic stricture (UEAS) rates. The MSKCC group demonstrated a 9.3% increased risk of UEAS in ORC patients (95% CI 1.5%-17%, P = .026) in their trial cohort.7 However, there are conflicting reports from other large retrospective series. Some have shown no difference in UEAS by surgical approach,8 while others have shown increased risk of UEAS with RARC with IUD compared to ORC.9 Whether RARC truly has an impact of UEAS rates remains unknown, and further research in this area is warranted.

Trends in Diversion Type

Some select centers have maintained high rates of continent diversion use over time (55% of all patients in some series1), but most published series have demonstrated declining utilization over the past several years.10 This trend is concurrent with the increasing adoption of RARC and IUD. Intracorporeal ileal conduit creation is complex and time intensive with a significant learning curve, and intracorporeal orthotopic neobladder creation compounds this complexity.11 While adoption of robotic surgery may contribute to stable or declining rates of continent diversion use, other long-standing factors including limited resident training, centralization of cystectomy care, technical complexity, and patient factors may also be mediating this trend.

Conclusions

Utilization of RARC is increasing rapidly despite limited evidence supporting its superiority over an open approach. Randomized trials have thus far failed to demonstrate the large benefits promised by RARC. This continued adoption mirrors the increased use of the robotic platform for radical prostatectomy and may reflect a national trend of decreasing trainee experience with complex open pelvic surgery.12 Despite these technical advances, radical cystectomy remains a high-risk surgery, and while there is abundant interest in the promise of surgical robotics, the centralization of cystectomy care to high-volume centers with surgeons performing the procedure using their preferred technique may be more impactful on patient outcomes.13 As new technologies push the boundaries of surgical bladder cancer management,14 time will tell what interventions ultimately have an impact on our patients.

  1. Bochner BH, Dalbagni G, Sjoberg DD, et al. Comparing open radical cystectomy and robot-assisted laparoscopic radical cystectomy: a randomized clinical trial. Eur Urol. 2015;67(6):1042-1050.
  2. Parekh DJ, Reis IM, Castle EP, et al. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial. Lancet. 2018;391(10139):2525-2536.
  3. Mastroianni R, Ferriero M, Tuderti G, et al. Open radical cystectomy versus robot-assisted radical cystectomy with intracorporeal urinary diversion: early outcomes of a single-center randomized controlled trial. J Urol. 2022;207(5):982-992.
  4. Catto JWF, Khetrapal P, Ricciardi F, et al. Effect of robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy on 90-day morbidity and mortality among patients with bladder cancer: a randomized clinical trial. JAMA. 2022;327(21):2092-2103.
  5. Hussein AA, Elsayed AS, Aldhaam NA, et al. Ten-year oncologic outcomes following robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. J Urol. 2019;202(5):927-935.
  6. Tanneru K, Jazayeri SB, Kumar J, et al. Intracorporeal versus extracorporeal urinary diversion following robot-assisted radical cystectomy: a meta-analysis, cumulative analysis, and systematic review. J Robot Surg. 2021;15(3):321-333.
  7. Huang C, Assel M, Beech BB, et al. Uretero-enteric stricture outcomes: secondary analysis of a randomised controlled trial comparing open versus robot-assisted radical cystectomy. BJU Int. 2022;130(6):809-814.
  8. Anderson CB, Morgan TM, Kappa S, et al. Ureteroenteric anastomotic strictures after radical cystectomy—does operative approach matter?. J Urol. 2013;189(2):541-547.
  9. Reesink DJ, Gerritsen SL, Kelder H, et al. Evaluation of ureteroenteric anastomotic strictures after the introduction of robot-assisted radical cystectomy with intracorporeal urinary diversion: results from a large tertiary referral center. J Urol. 2021;205(4):1119-1125.
  10. Almassi N, Bochner BH. Ileal conduit or orthotopic neobladder. Curr Opin Urol. 2020;30(3):415-420.
  11. Maqboul F, Thinagaran JKR, Dovey Z, Wiklund P. The contemporary status of robotic intracorporeal neobladder. Mini-invasive Surg. 2021;5:44.
  12. Merrill SB, Sohl BS, Thompson RH, et al. The balance between open and robotic training among graduating urology residents—does surgical technique need monitoring?. J Urol. 2020;203(5):996-1002.
  13. Tan WS, Leow JJ, Marchese M, et al. Defining factors associated with high-quality surgery following radical cystectomy: analysis of the British Association of Urological Surgeons cystectomy audit. Eur Urol Open Sci. 2021;33:1-10.
  14. Tyson M, Andrews P, Cheney S, et al. Single incision robotic cystectomy and hybrid orthotopic neobladder reconstruction: a step by step description. Urology. 2021;156:285-288.

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