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RECRUITING Phase 3 ClinicalTrials.gov

A Study of Surgical Techniques During Cystectomy

Sponsor: Memorial Sloan Kettering Cancer Center • ClinicalTrials.gov ID: NCT06703476

Registry updated: 2026-09-22
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Description

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.

Interventions

  • Stent placement (Procedure)
    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.
  • Alvimopan (Drug)
    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).

Eligibility criteria

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

Conditions

Bladder Cancer

Locations

  • Memorial Sloan Kettering at Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States
  • Memorial Sloan Kettering Monmouth (Consent Only) — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States
  • Memorial Sloan Kettering Suffolk-Commack (Consent Only) — Commack, New York, United States
  • Memorial Sloan Kettering Westchester (Consent Only) — Harrison, New York, United States
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States
  • Memorial Sloan Kettering Nassau (Consent Only) — Rockville Centre, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record