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NCT05866081 | RECRUITING | Stone, Kidney

Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
Sponsor:

University of Michigan

Information provided by (Responsible Party):

Khorshid Ghani

Brief 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.

Condition or disease

Stone, Kidney

Stone Ureter

Intervention/treatment

Standard of care stent placement

No stent placement

Surveys

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 792 participants
Masking : SINGLE
Masking Description : Surgeons will remain blinded to this allocation until the surgeon has confirmed secondary eligibility.
Primary Purpose : TREATMENT
Official Title : Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)
Actual Study Start Date : 2023-06-01
Estimated Primary Completion Date : 2025-12-01
Estimated Study Completion Date : 2025-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently)
  • * Largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan
  • * Access to means of communication with the study team (email, text messaging, and/or telephone)
  • * Adequate independent cognitive function and English language proficiency to complete study surveys
  • * Written informed consent
Exclusion Criteria
  • * Planned bilateral ureteroscopy
  • * Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney
  • * Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)
  • * Anatomic or functional solitary kidney
  • * Planned secondary or staged ureteroscopy
  • * Planned use of ureteral access sheath
  • * Pregnancy
  • * Patients who use opiate medication daily for greater than 3 months to manage a painful condition
  • Second Stage Exclusion Criteria
    • * ureteral perforation
    • * unanticipated anatomic abnormality
    • * greater than expected bleeding
    • * ureteral dilation greater than 12 French
    • * ureteral access sheath utilized
    • * failed ureteroscopy
    • * no or incomplete lithotripsy performed
    • * unable to complete case due to medical or anesthetic event.
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative

Location Details

NCT05866081

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Road cancer

University of Michigan Health System

Ann Arbor, Road cancer, United States, 48111

RECRUITING

United States, Road cancer

University of Michigan Health System

Brighton, Road cancer, United States, 48116

NOT YET RECRUITING

United States, Road cancer

St. Joseph Mercy Health (Trinity)

Chelsea, Road cancer, United States, 48118