RecruitingPhase 3NCT06703476

A Study of Surgical Techniques During Cystectomy

A Clinically Integrated Randomized Clinical Trial (RCT) of Modifications to Radical Cystectomy and Postoperative Care

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

530 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer

Summary

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.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different surgical practices during bladder removal surgery (cystectomy) for bladder cancer: whether to place internal stents (small tubes) at the connection between the ureter and the new bladder, and whether to use a drug called alvimopan to help the gut recover faster after surgery. **You may be eligible if...** - You are 21 or older - You have bladder cancer and are scheduled for radical cystectomy (surgical removal of the bladder) at Memorial Sloan Kettering Cancer Center **You may NOT be eligible if...** - You are on chronic opioid (strong painkiller) therapy — this would only exclude you from the alvimopan part of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStent placement

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.

DRUGAlvimopan

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).