RECRUITING

A Study of Surgical Techniques During Cystectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-21
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06703476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons at MSK
  1. * No exclusion criteria Alvimopan vs. no alvimopan
  2. * Patients on chronic opioid therapy are ineligible to receive alvimopan and will be excluded from this cohort of the trial

Contacts and Locations

Study Contact

Alvin Goh, MD
CONTACT
646-422-4667
goha@mskcc.org
Bernard Bochner, MD
CONTACT
646-422-4387

Principal Investigator

Alvin Goh, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Consent Only)
Rockville Centre, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Alvin Goh, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21
Study Completion Date2028-11

Study Record Updates

Study Start Date2024-11-21
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

  • Cystectomy
  • Ureteral stents
  • Alvimopan
  • 24-361

Additional Relevant MeSH Terms

  • Bladder Cancer