Comparison of Outcome of Three Days Bowel Preparation vs No Bowel Preparation in Patients of Colostomy Reversal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Anastomotic Leakage
研究概览
简要总结
The goal of this trial is to compare the outcomes of colostomy reversal with three days bowel preparation with no bowel preparation in terms of anastomotic leakage, surgical site infection and hospital stay.
The important question this trial aims to answer is:
1. is there any difference in outcomes after colostomy reversal with three days gut preparation pre-operatively vs no gut preparation?
This prospective Randomized Controlled trial will include children with colostomy divided into two groups:
Group A: No Mechanical Bowel Preparation Group B: 3 Days Mechanical Bowel Preparation Participants of Group A will be admitted 1 day prior to surgery date as they require no special preparation before surgery. They will be made Nil per oral 6 hours prior to surgery. Group B participants will be admitted 3 days prior to surgery. These participants will be restricted to fiber rich diet and milk 72 hours prior to surgery. They will be shifted to clear liquids 24 hours prior to surgery. Normal saline enema will be given 8 hourly through the stoma as well as per rectally by the trained person.
Comparative outcomes will be:
- Anastomotic leakage
- Hospital Stay
- Wound infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with colostomy between 1-15 years of age
排除标准
- •Malnourished
- •Previous history of colostomy site anastomotic leakage
研究组 & 干预措施
Group A Colostomy Reversal
Patients in this group will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
干预措施: No Mechanical Bowel Preparation (Procedure)
Group B Colostomy Reversal
Patients in this group will receive 3 days bowel preparation prior to undergoing colostomy reversal.
干预措施: Mechanical Bowel Preparation (Procedure)
结局指标
主要结局
Anastomotic Leakage
时间窗: 5-10 days post operatively.
In this outcome measure, it will be seen if there is any difference in both intervention in terms of number of participants with anastomotic (part of gut where two separate ends of colon have been sutured with each other) leakage.
Wound infection
时间窗: At 7 days after surgery and then at 30 days after surgery.
In this outcome variable, number of participants with infection at the site of colostomy reversal wound will be compared between both groups.
次要结局
未报告次要终点
研究者
Aziz Ahmad Chattha
Senior Registrar
University of Child Health Sciences and Children's Hospital, Lahore