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临床试验/NCT05715086
NCT05715086招募中不适用

Upfront vs Postponed Ureteroscopy (UPURS) Trial for Patient-centered Management of Symptomatic Obstructing Stones

University of California, San Francisco4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
4
主要终点
Pain Score

研究概览

简要总结

A prospective, non-blinded, randomized controlled trial studying the management of symptomatic ureteral stones. This study will compare upfront ureteroscopy vs observation and delayed intervention for patients presenting to the emergency department with a symptomatic ureteral stone.

详细描述

Management of symptomatic ureteral stones is variable across the United States due to a lack of clear, patient-centered guidelines. For patients who do not meet criteria for emergent stenting, the decision to recommend upfront definitive treatment (ureteroscopy, ESWL) or medical expulsion therapy is influenced by factors such as practice setting, insurance status, and day of the week. This has resulted in health disparities and delays in care that disproportionately affect vulnerable patient populations.

For patients presenting to the emergency department with a symptomatic ureteral stone investigators will randomize into Group A: Upfront Ureteroscopy or Group B: Delayed intervention and observation. Both arms are considered standard of care for patients presenting with the above diagnosis.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presenting to the Emergency Department (ED)
  • Adult (> 18 yo)
  • ≥5mm ureteral stone diagnosed on CT scan
  • Presence of symptoms (pain, nausea, vomiting, hematuria)

排除标准

  • Strict indication for stent
  • Stone burden not amenable to Ureteroscopy (URS)
  • Dirty urine analysis (UA) or positive urine culture (UCx)
  • Transplant kidney
  • Presence of conduit
  • Comorbidities not optimized for surgery
  • Strong preference for surgery or observation

研究组 & 干预措施

Group A (Upfront ureteroscopy)

Active Comparator

干预措施: Ureteroscopy (Procedure)

Group B (Observation/delayed ureteroscopy)

No Intervention

结局指标

主要结局

Pain Score

时间窗: 3 months

Measure on a scale of 1-10, with zero indicating no pain and 10 indicating the worst pain.

Anxiety Score

时间窗: 3 months

Measure on a scale of 1-10, the score ranges from 0-10, with zero indicating no anxiety and 10 indicating the worst anxiety.

次要结局

  • Hospital visit length(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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