Clinical trial · Interventional
Robotic or Open Radical Cystectomy in Treating Patients With Bladder Cancer
Prospective Randomized Comparison of Robotic Versus Open 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): PI decided to revamp the protocol completely and will submit as new study.
Summary
Brief summary (as posted)
This randomized phase II trial studies how well robotic radical cystectomy (RRC) or open radical cystectomy (ORC) works in treating patients with bladder cancer. Cystectomy is a surgical procedure to remove all or part of the bladder (the organ that holds urine) or to remove a cyst (a sac or capsule in the body). In RRC, the the surgeon makes small cuts in the abdomen and uses a thin, lighted instrument with a camera attached called a scope. With the help of a robot, the surgeon removes the bladder and other nearby structures. In ORC, the surgeon makes a cut into the lower abdomen to expose the urinary tract in order to remove the bladder and nearby structures. It is not yet known whether RRC or ORC has fewer complications, better quality of life, and faster recovery time in treating patients with bladder cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage 0is Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire Administration | Other | — | UNRESOLVED |
| Radical Cystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (RRC)
- description
- Patients undergo RRC at day 0.
- interventionNames
- Other: Questionnaire Administration
- Procedure: Radical Cystectomy
- type
- EXPERIMENTAL
- label
- Arm II (ORC)
- description
- Patients undergo ORC at day 0.
- interventionNames
- Other: Questionnaire Administration
- Procedure: Radical Cystectomy
Primary outcomes (1)
- measure
- Change in patient reported quality of life, as measured by the EORTC-QLQ-C30
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Indication for radical cystectomy for urothelial cancer * All types of urinary diversions * Tis-T3 Urothelial cancer; patients will be stratified according to clinical stage * Ability to consent * Patient meets criteria to be a surgical candidate Exclusion Criteria: * Inability to give consent or adhere to follow-up schedule * T4 tumor * Bulky lymphadenopathy (\> 2 cm) * Prior pelvic radiation * Not surgical candidate because of significant co-morbidity * Uncontrolled coagulopathy
References
Publications (0)
Data not yet available