跳至主要内容
临床试验/CTRI/2025/03/082683
CTRI/2025/03/082683尚未招募不适用

Comparative analysis of outcomes with Suctioning vs non-suctioning ureteral access sheath in retrograde intrarenal surgeries

Manipal Academy of Higher Education Udupi1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年3月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
Stone free rates The percentage of patients with no

研究概览

简要总结

Patients eligible for Retrograde Intrarenal Surgery will be identified from both the OPD and indoor services at KMC Manipal We will offer potential participants the choice of undergoing the RIRS procedure as part of their treatment for renal calculi

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
10.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing RIRS at KMC Hospital, Manipal
  • Stone size: less than 2.0cm, max diameter is any one one dimension
  • Pre stented status.

排除标准

  • Uncorrected coagulopathy.
  • Active UTI
  • Large stone burden greater than 2.0cm
  • Failure of previous treatment
  • Ureteric malformations or anomalous renal anatomy including low lying kidneys or kidneys with calyceal diverticulae
  • Pregnancy
  • Patients who have undergone ureteral repair surgeries
  • Surgeries converted to PCNL.

结局指标

主要结局

Stone free rates The percentage of patients with no

时间窗: 1 month

residual stones or fragments less than 2mm after surgery as assessed by a follow up NCCT KUB

时间窗: 1 month

次要结局

  • Hospital stays in hours(1 day)
  • Surgeon Assessment Questionnaire to record surgeon experience with(and without suction)
  • Operative time from the insertion of the endoscope to its removal(1 day)
  • Difference in infective & renal function parameters with appropriate tests(1 day)

研究者

发起方
Manipal Academy of Higher Education Udupi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Varun Agarwal

Kasturba Medical College, Manipal

研究点 (1)

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