About this trial
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:
1. Anastomotic leakage 2. Hospital Stay 3. Wound infection
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children with colostomy between 1-15 years of age
Disqualifiers
Malnourished
Previous history of colostomy site anastomotic leakage
Trial design
Parallel
Treatments tested in this trial
No Mechanical Bowel Preparation
Procedure/SurgeryIn this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
Mechanical Bowel Preparation
Procedure/SurgeryIn this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal.
Treatment groups
Trial outcomes
Primary outcomes
Anastomotic Leakage
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
In this outcome variable, number of participants with infection at the site of colostomy reversal wound will be compared between both groups.
Sponsors and contacts
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