Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
Start Date
6/1/2023
Completion Date
5/1/2026
Summary
This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent. Eligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission. Eligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants. The study team hypothesizes that: * Pain interference change from pre-surgery to Day 7-10 will differ between the two treatment arms. This hypothesis will be evaluated separately in the randomized and observational cohorts. * Unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. This hypothesis will be evaluated separately in the randomized and observational cohorts.
Detailed Description
The coordinating center for this study is the Michigan Urological Surgery Improvement Collaborative (MUSIC), which is a physician-led Quality Improvement (QI) collaborative comprised of 44 urology practices and 260 urologists across the State of Michigan. As sites are activated the registration will be updated.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Standard of care stent placement
No stent placement
Surveys
Conditions
Locations
University of Arizona
Tucson, Arizona 85724
United States
UF Health Shands Hospital
Gainesville, Florida 32608
United States
Indiana University Department of Urology
Indianapolis, Indiana 46202
United States
University of Michigan Health System
Ann Arbor, Michigan 48111
United States
University of Michigan Health System
Brighton, Michigan 48116
United States
Cadillac Munson Hospital
Cadillac, Michigan 49601
United States
St. Joseph Health System Chelsea Hospital
Chelsea, Michigan 48118
United States
St. Joseph Mercy Health (Trinity)
Chelsea, Michigan 48118
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Corewell Health Buttersworth Hospital
Grand Rapids, Michigan 49503
United States
E.W Sparrow Hospital
Lansing, Michigan 48912
United States
MyMichigan Medical Center Midland
Midland, Michigan 48670
United States
Michigan Institute of Urology Town Center Ambulatory Surgery Center
Troy, Michigan 48084
United States
Monte Fiore
Brooklyn, New York 10467
United States
Mount Sinai
New York, New York 10029
United States
UNC Hospital
Chapel Hill, North Carolina 27514
United States