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

RecruitingNAAges 18 Years - anyAllUniversity of Michigan
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In plain words

What the trial is, and whether it could suit you

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 utili

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Standard of care stent placement
  • No stent placement
  • Surveys
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Where

16 sites
University of Arizona
Tucson, United States
UF Health Shands Hospital
Gainesville, United States
Indiana University Department of Urology
Indianapolis, United States
University of Michigan Health System
Ann Arbor, United States
University of Michigan Health System
Brighton, United States
Cadillac Munson Hospital
Cadillac, United States
St. Joseph Health System Chelsea Hospital
Chelsea, United States
St. Joseph Mercy Health (Trinity)
Chelsea, United States

โ€ฆand 8 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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