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Purpose

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

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
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
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Stent vs No Stent 		For patients treated by a surgeon randomized to use ureteral stents, the operating 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 to be placed across the ureteroenteric anastomosis intraoperatively. Because there is no standard ureteral stent size or type, the surgeon will select a stent type and size according to their experience and will document the stent size and type used. This is already routinely recorded as part of the standard of care at MSK.
  • Procedure: Stent 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.
Experimental
Alvimopan vs No Alvimopan 		For patients randomized to receive alvimopan, the 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), as indicated on the medication's FDA label. This is the current standard of care for most cases at MSK.
  • Drug: Alvimopan
    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).

Recruiting Locations

Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey 07920
Contact:
Alvin Goh, MD
646-422-4667

Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey 07748
Contact:
Alvin Goh, MD
646-422-4667

Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey 07645
Contact:
Alvin Goh, MD
646-422-4667

Memorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York 11725
Contact:
Alvin Goh, MD
646-422-4667

Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York 10604
Contact:
Alvin Goh, MD
646-422-4667

Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York 10065
Contact:
Alvin Goh, MD
646-422-4667

Memorial Sloan Kettering Nassau (Consent Only)
Rockville Centre, New York 11553
Contact:
Alvin Goh, MD
646-422-4667

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Alvin Goh, MD
646-422-4667
goha@mskcc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.