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临床试验/NCT07176026
NCT07176026Enrolling By Invitation不适用

Follow-Up of Ureteral Stones ≤4 mm: Evaluate the Proportion of Spontaneous Passage and Assess if Symptoms and Stone Characteristics Can Predict Stone Passage

Region Skane2 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
Region Skane
入组人数
1,600
试验地点
2
主要终点
Number of ureteral stones ≤ 4mm that pass spontaneously

研究概览

简要总结

The goal of this clinical trial is to evaluate the proportion of ureteral stones ≤4 mm that pass spontaneously within 4 and 8 weeks and assess if pain, blood test (S-creatinine), stone size, stone location and hydronephrosis can predict stone passage. The participants will be asked to fill in a questionare regarding symptoms, give a blood test and undergo a follow-up computed tomography.

详细描述

All patients with a diagnosis of ureteral stone ≤4 mm at the Emergency Department in Helsingborg will be asked to participate. If they give consent data regarding age, gender, stone size, stone location, hydronephrosis, S-creatinine, treatments and results from the follow up CT is extraced from the medical records.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • all patients with acute renal colic where a CT within 24 hours shows an ureteral stone ≤ 4mm and there is no need for acute intervention.

排除标准

  • Those who decline to participate, those who are put under guardianship or is less than 18 years old.

结局指标

主要结局

Number of ureteral stones ≤ 4mm that pass spontaneously

时间窗: From enrolement to passage of the stone or maximum 8 weeks.

Number of participants with residual pain

时间窗: From enrolement to passage of the stone or maximum 8 weeks.

Residual pain is measured with VAS (visual analogue scale), values 0-10. VAS 0 = no pain and VAS 10 = worst possible pain.

次要结局

  • Proportion of ureteral stone that have passed according to anatomical localisation, S-creatinine and presence of hydronephrosis.(From enrolement to passage of the stone or maximum 8 weeks.)
  • QoL form including sick leave and return to full ADL(From enrolement to passage of the stone or maximum 8 weeks.)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (2)

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