Clinical trial · Interventional
Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer
Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): waiting on surgeon training
Summary
Brief summary (as posted)
This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion during robotic assisted radical cystectomy in reducing complications in patients with bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a new way for urine to leave the body) is performed. It is not yet known whether intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion is a better method in patients with bladder cancer undergoing robotic assisted radical cystectomy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage 0 Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Urinary Complications | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraoperative complication management/prevention | Other | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
| robot-assisted laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (RARC with IUD)
- description
- Patients undergo RARC with IUD.
- interventionNames
- Procedure: robot-assisted laparoscopic surgery
- Other: intraoperative complication management/prevention
- Other: quality-of-life assessment
- type
- EXPERIMENTAL
- label
- Arm II (RARC with EUD)
- description
- Patients undergo RARC with EUD.
- interventionNames
- Procedure: robot-assisted laparoscopic surgery
- Other: intraoperative complication management/prevention
- Other: quality-of-life assessment
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Grade G1 - G3 bladder cancer * T stage: cTis - T2 * N0 * M0 * American Society of Anesthesiologists (ASA) \< 4 * Informed consent * Eastern Cooperative Oncology Group (ECOG) performance status 2 or better * Hemoglobin (Hgb) \> 8.0 g/dL * White blood cell (WBC) \> 2.0 k/uL * Platelets \> 50,000 * Creatinine \< 3.0 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) \< 5.0 x ULN * Alanine transaminase (ALT) \< 5.0 x ULN Exclusion Criteria: * Patient unsuitable for or refusing radical cystectomy * T stage ≥ T3 (mass extending outside the bladder) * Gross nodal or metastatic disease at presentation (≥ N1, M1) * Prior pelvic radiation * Prior open or laparoscopic/robotic bladder or prostate surgery * Prior colorectal surgery or history of inflammatory bowel disease * Body mass index (BMI) ≥ 40 * ECOG performance status 3 or worse * History of coagulopathy or bleeding disorders * Chronic steroid use * Patients with end stage renal disease (ESRD) and/or on dialysis
References
Publications (0)
Data not yet available