A Study of Surgical Techniques During Cystectomy

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

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.

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