A Study of Surgical Techniques During Cystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stent placement, Alvimopan.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinically Integrated Randomized Clinical Trial (RCT) of Modifications to Radical Cystectomy and Postoperative Care
Overview
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.
Interventions
- 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. - 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).
Primary outcome measures
- Length of hospital stay (Alvimopan) [Time frame: greater than 6 days]
- Symptomatic urinary tract infections (Stents) [Time frame: within 30 days of surgery]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Memorial Sloan Kettering at Basking Ridge (Consent Only) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent Only) — Middletown
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale
- Memorial Sloan Kettering Suffolk-Commack (Consent Only) — Commack
- Memorial Sloan Kettering Westchester (Consent Only) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
- Memorial Sloan Kettering Nassau (Consent Only) — Rockville Centre
Identifiers
NCT: NCT06703476 · 24-361