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NCT06703476 | RECRUITING | Bladder Cancer

A Study of Surgical Techniques During Cystectomy
Sponsor:

Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease

Bladder Cancer

Intervention/treatment

Stent placement

Alvimopan

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 530 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Clinically Integrated Randomized Clinical Trial (RCT) of Modifications to Radical Cystectomy and Postoperative Care
Actual Study Start Date : 2024-11-21
Estimated Primary Completion Date : 2028-11
Estimated Study Completion Date : 2028-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 at MSK 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 at MSK
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
A Study of Surgical Techniques During Cystectomy

Location Details

NCT06703476

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering at Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk-Commack (Consent Only)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Consent Only)

Rockville Center, New York, United States, 11553