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临床试验/CTRI/2024/10/074635
CTRI/2024/10/074635招募中4 期

Effectiveness of N acetyl cysteine and Simethicone to improve mucosal visibility during GI endoscopy-An interventional study

Dean,Kasturba Medical college,Manipal1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年10月9日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
112
试验地点
1
主要终点
The total mucosal visibility score is used to asses the improvement in mucosal visibility between the two groups

研究概览

简要总结

The patient will be explained about the procedure and if willing can be considered as a case and the remaining will be considered as control. Proforma filled for patients meeting the criteria in the prescribed format-consent taking. The patients are asked to drink the premedication mixed with water 20-30minutes before the procedure. Upper GI endoscopy is done and multiple images are taken from esophagus ,stomach and duodenum .The total mucosal visibility score(TMVS) ,scored from 1-4,each segment is measured as the primary outcome. The total duration of the procedure is also assessed in minutes by endoscopists as a secondary outcome measure.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing upper GI endoscopy.

排除标准

  • Acute or ongoing upper GI bleed History of previous upper GI surgeries Progressive dysphagia Gastric outlet obstruction Inadequate fasting before the procedure Severe esophageal or gastric inflammation due to corrosive intake Unwilling to give conssent.

结局指标

主要结局

The total mucosal visibility score is used to asses the improvement in mucosal visibility between the two groups

时间窗: 20months

次要结局

  • Reduced duration of procedure(20months)

研究者

发起方
Dean,Kasturba Medical college,Manipal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DrSaakshi Pandit

Kasturba hospital,manipal

研究点 (1)

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