Clinical trial · Interventional
A Study of Surgical Techniques During Cystectomy
A Clinically Integrated Randomized Clinical Trial (RCT) of Modifications to Radical Cystectomy and Postoperative Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. This trial will evaluate whether the following surgical methods influence outcomes: A ureteral stent is a thin tube that is placed in the ureter to drain urine from the kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection. Alvimopan is a standard drug used to promote return of bowel function following surgery. Doctors do not know whether alvimopan is beneficial in current clinical practice. The surgeon will decide whether participants will receive a stent and/or alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alvimopan | Drug | — | UNRESOLVED |
| Stent placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stent vs No Stent
- description
- For patients treated by a surgeon randomized to use ureteral stents, the operating surgeon may choose to use a single or double J ureteral stent (6- to 8.5-fr in size) or an alternative ureteral stent of the surgeon's choice to be placed across the ureteroenteric anastomosis intraoperatively. Because there is no standard ureteral stent size or type, the surgeon will select a stent type and size according to their experience and will document the stent size and type used. This is already routinely recorded as part of the standard of care at MSK.
- interventionNames
- Procedure: Stent placement
- type
- EXPERIMENTAL
- label
- Alvimopan vs No Alvimopan
- description
- For patients randomized to receive alvimopan, the patient will receive alvimopan as a fixed 12-mg dose, with the first dose administered 0.5 to 5 h before the start of surgery; administration will be continued with twice daily oral doses postoperatively until hospital discharge or a maximum of 7 days (15 in-hospital doses), as indicated on the medication's FDA label. This is the current standard of care for most cases at MSK.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: Stent vs. no stent * Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons Alvimopan vs. no alvimopan * Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons Exclusion Criteria: Stent vs. no stent * No exclusion criteria Alvimopan vs. no alvimopan * Patients on chronic opioid therapy are ineligible to receive alvimopan and will be excluded from this cohort of the trial
References
Publications (0)
Data not yet available