A Study of Surgical Techniques During Cystectomy
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
- Bladder Cancer
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
| Arm | Description | Assigned 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. |
|
|
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. |
|
Recruiting Locations
Basking Ridge, New Jersey 07920
Alvin Goh, MD
646-422-4667
Middletown, New Jersey 07748
Alvin Goh, MD
646-422-4667
Montvale, New Jersey 07645
Alvin Goh, MD
646-422-4667
Commack, New York 11725
Alvin Goh, MD
646-422-4667
Harrison, New York 10604
Alvin Goh, MD
646-422-4667
New York, New York 10065
Alvin Goh, MD
646-422-4667
Rockville Centre, New York 11553
Alvin Goh, MD
646-422-4667
More Details
- Status
- Recruiting
- Sponsor
- Memorial Sloan Kettering Cancer Center