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临床试验/CTRI/2024/09/074178
CTRI/2024/09/074178尚未招募2/3 期

A prospective randomized control study assessing the feasibility and safety of complete intra-ureteric stent on a string following upper tract ureteroscopy

Christian Medical Collge1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年9月24日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
82
试验地点
1
主要终点
To compare the quality of life , stent related symptoms and complication rates between ureteric stent on strings and conventional ureteric stent using the validated Ureteral Stent Symptom Questionnaire

研究概览

简要总结

Ureteroscopy (URS) is a common procedure for removing upper urinary tract stones. Ureteric stent placement after URS is a routine practice. Placement of conventional ureteric stents is associated with stent related symptoms due to irritation of the bladder by the intravesical lower coil. Conventional stents are routinely removed using cystoscopy which entail added cost and discomfort which may be circumvented by stent on strings that may be pulled out by the patient/ clinician without the need for cystoscopy. This study aims to assess the safety and feasibility of complete intra- ureteric stent with attached strings following upper tract ureteroscopy

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
17.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients who have a ureteric stent inserted after upper tract ureteroscopic procedures for unilateral stone disease.

排除标准

  • pediatric patients, patients undergoing bilateral procedures, anatomical abnormalities, solitary functioning kidney, incomplete treatment, planned for staged procedures, coexisting non calculous diseases, prior ureteric stenting, impacted vesico-ureteric junction calculus and complicated URSL requiring long term stent placement.

结局指标

主要结局

To compare the quality of life , stent related symptoms and complication rates between ureteric stent on strings and conventional ureteric stent using the validated Ureteral Stent Symptom Questionnaire

时间窗: USSQ score assessed on post op day (POD) 1, POD3, prior to stent removal and 1 day after stent removal

次要结局

  • 1. To study the cost effectiveness of complete intra- ureteric stent with attached strings.(From september 2024)

研究者

发起方
Christian Medical Collge
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Aswath V

Christian Medical College, Vellore

研究点 (1)

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