Clinical trial · Interventional
Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
Bladder Cancer: Open Versus Laparoscopic or Robotic Cystectomy. A Study to Determine the Feasibility of Randomization to Open Versus Minimal Access Cystectomy in Patients With Bladder Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than is used in standard surgery. It is not yet known whether minimal-access surgery to remove the bladder is more effective than standard surgery to remove the bladder in treating patients with bladder cancer. PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| robot-assisted laparoscopic surgery | Procedure | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| therapeutic laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of patients who consent to be randomized
Secondary outcomes (4)
- measure
- Potential barriers to randomization via semistructured qualitative interviews with patients who consent to registration and do not accept randomization
- measure
- Potential factors relating to non-registration of patients who are eligible for inclusion but have not been registered based on review of anonymous screening logs
- measure
- Safety and efficacy
- measure
- Quality of life data measuring return to normal activities (physical, social, and occupational)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histopathologically confirmed bladder cancer, including any of the following cell types: * Urothelial cell (transitional cell) carcinoma * Squamous cell carcinoma * Adenocarcinoma * Stage pT1, pT2, or pT3 disease OR mobile bladder mass on bimanual examination under anesthesia * No enlarged nodes or distant metastases on CT or MRI scan of the abdomen and pelvis * No upper urinary tract disease PATIENT CHARACTERISTICS: * American Society of Anesthesiologist (ASA) status 1-3 * Life expectancy \> 24 months * Not pregnant or nursing * Negative pregnancy test * No concurrent disease that would render the patient unsuitable for the trial * No presence of urosepsis PRIOR CONCURRENT THERAPY: * May have received prior neoadjuvant chemotherapy provided study surgery is performed between 3 and 10 weeks from the date of the completion of chemotherapy treatment
References
Publications (0)
Data not yet available