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临床试验/CTRI/2025/05/087323
CTRI/2025/05/087323尚未招募3 期

Effect of Preoperative Efferent limb Enteral Stimulation on Ileostomy Closure

Jawaharlal Nehru Medical College AMU Aligarh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月26日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
return of bowel activity

研究概览

简要总结

in this trial titled "Effect of Preoperative Efferent limb Enteral Stimulation on Ileostomy Closure"

we will be studying effects of efferent limb stimulation prior to ileostomy closure on various post-op parameters.

After informed consent patients wound be randomly assigned to 2 groups each undergoing ileostomy closure.

Patients in the study group will be trained to do daily stimulation of the

efferent stomal segment by using a thick solution (500 mL of physiological

saline mixed with 30 g of protein-enriched thickening agent) 2 weeks prior to planned ileostomy closure.

Patients in the control group will not be subjected to daily stimulation of the

efferent stomal segment by using a thick solution.

pateint will be kept under observation post-operatively, and parameters like time taken for return of normal bowel activity, tolerence of oral feed, length of hospital stay and levels of biochemical marker( TSPAG, IL-6 and CRP)  will be compared between both groups..

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
14.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patient giving consent for their inclusion in the study.
  • Patients having ileostomy following emergency exploratory laparotomy.

排除标准

  • Patient not giving the consent Hemodynamically unfit patient Patient undergoing ileostomy closure for elective laprotomy H/O multiple abdominal surgery.

结局指标

主要结局

return of bowel activity

时间窗: at baseline, 24hr, 48hr, 72hr, 96hr and 120hr after sugery

次要结局

  • tolerence of oral feed(2nd day, 3rd day, 4th day, 5th day & 6th days after surgery)
  • length of hospital stay(at 4th day, 5th day, 6 th day, 7th day, 8th day, 9th day & 10th day of surgery)
  • compare protien status & biochemical markers( TSPAG,IL-6 & CRP)(before stimulation, after stimulation & after ileostomy closure)

研究者

发起方
Jawaharlal Nehru Medical College AMU Aligarh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Asjad Ahmad Siddiqui

Jawaharlal Nehru medical college, Aligarh Muslim university, Aligarh

研究点 (1)

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