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A Study of Surgical Techniques During Cystectomy

RECRUITINGPhase 3Sponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
PhasePhase 3
SponsorMemorial Sloan Kettering Cancer Center
Started2024-11-21
Est. completion2028-11
Eligibility
Age21 Years+
Healthy vol.Accepted
Locations7 sites

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

Age: 21 Years+Healthy volunteers accepted
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

Conditions2

Bladder CancerCancer

Locations7 sites

Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Alvin Goh, MD646-422-4667
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Alvin Goh, MD646-422-4667
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Alvin Goh, MD646-422-4667
Memorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York, 11725
Alvin Goh, MD646-422-4667
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Alvin Goh, MD646-422-4667

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