Clinical trial NCT06703476: A Study of Surgical Techniques During Cystectomy
Official title: A Clinically Integrated Randomized Clinical Trial (RCT) of Modifications to Radical Cystectomy and Postoperative Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: Cystectomy
Ureteral stents
Alvimopan
24-361
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 530
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study will use a cluster randomized trial design with crossover wherein surgeons will be cluster randomized for periods of 3 months to use or not use stents and to administer or not administer alvimopan. In addition, a factorial design will be used wherein the 2 study interventions (use of stents and use of alvimopan) will be investigated in the same group of patients.
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: Length of hospital stay (Alvimopan)
timeFrame: greater than 6 days
measure: Symptomatic urinary tract infections (Stents)
timeFrame: within 30 days of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Consent Only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent Only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activites)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Consent Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alvin Goh, MD
role: PRINCIPAL_INVESTIGATOR
References: