A Study of Surgical Techniques During Cystectomy

Phase 3
Recruiting
Conditions
Interventions
Registration Number
NCT06703476
Lead 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:
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Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
530
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Stent vs No StentStent placementFor 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.
Alvimopan vs No AlvimopanAlvimopanFor 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.
Primary Outcome Measures
NameTimeMethod
Length of hospital stay (Alvimopan)greater than 6 days

we will define success for the intervention as a length of stay \<6 days (6 days is the current median length of stay).

Symptomatic urinary tract infections (Stents)within 30 days of surgery

defined as the presence of signs or symptoms indicative of infection (fever, flank or abdominal pain, leukocytosis, radiographic imaging consistent with pyelonephritis) and a positive urine culture (\>100,000 CFU pathogenic bacteria on an appropriately collected urine specimen).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

Memorial Sloan Kettering at Basking Ridge (Consent Only)

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Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent Only)

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Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent Only)

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Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Consent Only)

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Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent Only)

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Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

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New York, New York, United States

Memorial Sloan Kettering Nassau (Consent Only)

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Rockville Centre, New York, United States

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