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A Study of Surgical Techniques During Cystectomy

StatusRecruiting
PhasePhase 3
Started2024-11-21
View on ClinicalTrials.gov ↗

Amendment history

2026-07-10
minor
Study Status, Eligibility v6
Eligibility criteria-14 characters
[...] tment of bladder cancer with one of the consenting surgeons at MSK Alvimopan vs. no alvimopan Patients aged ≥21 years who are s [...] atment of bladder cancer with one of the consenting surgeons at MSK Exclusion Criteria: Stent vs. no stent No exclusion criteri [...]
2026-01-26
minor
5 amendments v1-v5
5 re-verifications since 2025-04-02, no change to tracked fields
2024-11-21
minor
Original filing
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.
Trial Details
NCT Number NCT06703476
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Bladder Cancer
Enrollment 530 participants
Start Date 2024-11-21
Primary Completion 2028-11 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-22