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临床试验/NCT03657667
NCT03657667已完成不适用

Evaluation of Pain Before and After Removal of Non-obstructive Kidney Stones

Centre hospitalier de l'Université de Montréal (CHUM)18 个研究点 分布在 2 个国家目标入组 43 人开始时间: 2018年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
18
主要终点
Evaluation of pain

研究概览

简要总结

Pain associated with renal stone disease is typically caused by an obstructing stone that obstructs the flow of urine, which results in renal collecting system dilatation. Non-obstructing renal calculi that do not cause renal collecting system dilatation are thought to be painless. The objective of this study is to prospectively determine if the removal of non-obstructing renal calculi can reduce or eliminate participant's pain and/or improve their quality of life.

详细描述

Research Protocol

  • Title of research project: Evaluation of pain before and after removal of non-obstructing renal calculi.
  • Identification of Principal Investigator: Dr. Naeem Bhojani
  • Multicentric study

Rationale & background information Renal stone disease is a common condition representing a lifetime occurrence risk of 10% in men and 7% in women. Renal stone disease is a chronic condition with a high recurrence rate. Additionally, renal stone disease is associated with considerable morbidity including pain. Pain associated with renal stone disease is typically caused by an obstructing stone that obstructs the flow of urine, which results in renal collecting system dilatation. This increases the intraluminal pressure of the urinary collecting system and stretches nerve ending in the ureteral mucosa and renal capsule. Non-obstructing renal calculi that do not cause renal collecting system dilatation are thought to be painless. There is however, some evidence that non-obstructing renal calculi located within the renal calyces actually do cause pain. In a small (n=13) retrospective study, it was found that ureteroscopic removal of non-obstructing renal calyceal stones achieved complete or partial resolution of pain in all patients. The reason for this pain is unknown.

Objective and hypothesis Objective To prospectively determine if the removal of non-obstructing renal calculi can reduce or eliminate participant's pain and/or improve their quality of life.

Hypothesis We hypothesize that the removal of non-obstructing renal calculi will decrease or eliminate the participant's pain and will improve their quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Patients with renal colic and non-obstructing renal calculi. No stone greater than 10 mm in longest diameter
  • All other causes of pain have been eliminated (by clinical judgment; if the cause of pain is in doubt: assessment by a family doctor or medical specialist will be obtained)
  • Patients older than 18 years old
  • Moderate to severe pain (> or = 5 on BPI pain scale: pain at its worst in the last 24hrs)

排除标准

  • Patient's with anatomic abnormalities (calyceal diverticulum)
  • Ureteral calculi
  • Nephrocalcinosis
  • RTA, medullary sponge kidney, sarcoidosis
  • Hydronephrosis or hydrocalycosis
  • Minimal pain (<5 on BPI pain scale: pain at its worst in the last 24 hrs)

结局指标

主要结局

Evaluation of pain

时间窗: 12 weeks

evaluated using The Brief Pain Inventory; scale from 0-10; worst pain is 10

次要结局

未报告次要终点

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (18)

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