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Brief Title: Surgical Techniques During Cystectomy

A Clinically Integrated Randomized Clinical Trial (RCT) of Modifications to Radical Cystectomy and Postoperative Care

INTRODUCTION

  • Org Study ID: 24-361
  • Secondary ID: N/A
  • NCT ID: NCT06703476
  • Sponsor: Memorial Sloan Kettering Cancer Center

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 your ureter to drain urine from your 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.

  • Overall Status
    Recruiting
  • Start Date
    November 21, 2024
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Length of hospital stay (Alvimopan)

Primary Outcome 1 - Timeframe: greater than 6 days

Primary Outcome 2 - Measure: Symptomatic urinary tract infections (Stents)

Primary Outcome 2 - Timeframe: within 30 days of surgery

CONDITION

  • Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Alvin Goh, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Alvin Goh, MD, Bernard Bochner, MD

Phone: 646-422-4667, 646-422-4387

Email: [email protected]

LOCATION

Facility Status Contact
Facility: Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey 07920
United States 		Status: Recruiting Contact: Contact
Alvin Goh, MD
646-422-4667
Facility: Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey 07748
United States 		Status: Recruiting Contact: Contact
Alvin Goh, MD
646-422-4667
Facility: Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey 07645
United States 		Status: Recruiting Contact: Contact
Alvin Goh, MD
646-422-4667
Facility: Memorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York 11725
United States 		Status: Recruiting Contact: Contact
Alvin Goh, MD
646-422-4667
Facility: Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York 10604
United States 		Status: Recruiting Contact: Contact
Alvin Goh, MD
646-422-4667
Facility: Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York 10065
United States 		Status: Recruiting Contact: Contact
Alvin Goh, MD
646-422-4667
Facility: Memorial Sloan Kettering Nassau (Consent Only)
Rockville Centre, New York 11553
United States 		Status: Recruiting Contact: Contact
Alvin Goh, MD
646-422-4667

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