Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 792
- 试验地点
- 31
- 主要终点
- Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Surgeons will remain blinded to this allocation until the surgeon has confirmed secondary eligibility.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative
时间窗: Preoperative, Day 7-10
This survey has 6 questions that participants select from 1(not at all) to 5 (very much) for questions 1-5 related to pain interference. For question 6 participants select from 1 (Never) to 5 (Always). There are total of 6-30 points where the higher the score the more pain interference.
Number of Participants with Wins from the Hierarchical Unplanned stone treatment related healthcare utilization Composite Rank Score
时间窗: within 30 days after ureteroscopy
Compare within each cohort each No Stent Placement patient head-to-head against each Stent Placement patient using a hierarchical composite comprised of: * Intensive care unit (ICU) care during hospitalization * Unplanned hospitalization * Unplanned additional procedure related to ureteroscopy: operating room or interventional radiology procedure * Emergency department visit * Unplanned clinic visit and/or diagnostic testing (blood, urine testing and/or imaging) * Number of ambulatory patient-provider interactions: phone calls / Electronic Medical Record (EMR) messages
次要结局
- Number of Participants with Unplanned hospital admission within postoperative day 30(within 30 days after ureteroscopy)
- Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30(within 30 days after ureteroscopy)
- Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30(within 30 days after ureteroscopy)
- Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30(within 30 days after ureteroscopy)
- Number of Participants with Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30(within 30 days after ureteroscopy)
- Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30(within 30 days after ureteroscopy)
- PROMIS® Pain Interference (Short Form 6b) change at postoperative 4-6 weeks compared to preoperative(preoperative, 4-6 weeks)
- PROMIS® Pain Intensity (Short Form 3a) change at postoperative day 7-10 preoperative(preoperative, postoperative day 7-10)
- National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative day 7-10 compared to preoperative(preoperative, postoperative day 7-10)
- International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative 4-6 weeks(Postoperative 4-6 weeks)
- PROMIS® Pain Intensity (Short Form 3a) change at postoperative 4-6 weeks compared to preoperative(preoperative, postoperative 4-6 weeks)
- National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative 4-6 weeks compared to preoperative(preoperative, postoperative 4-6 weeks)
- International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative day 7-10(Postoperative day 7-10)
- Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy(First 7 days after ureteroscopy)
研究者
Khurshid Ghani
Professor of Urology
University of Michigan