An interventional study of No Mechanical Bowel Preparation and Mechanical Bowel Preparation in Colostomy - Stoma, Bowel Preparation and BOWEL ANASTOMOSIS, sponsored by University of Child Health Sciences and Children's Hospital, Lahore. Recruiting at 1 site in Pakistan. Open to participants aged 1 Year to 15 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by University of Child Health Sciences and Children's Hospital, Lahore · Not applicable, Interventional, and Treatment
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:
University of Child Health Sciences and Children's Hospital, Lahore is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Patients in this group will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
Procedure: No Mechanical Bowel Preparation
Patients in this group will receive 3 days bowel preparation prior to undergoing colostomy reversal.
Procedure: Mechanical Bowel Preparation
In this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
In this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal.
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.
Time frame: 5-10 days post operatively.
Wound infection
In this outcome variable, number of participants with infection at the site of colostomy reversal wound will be compared between both groups.
Time frame: At 7 days after surgery and then at 30 days after surgery.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — all IPD that underlie results in a publication after deidentification (text, table, figures and appendices)
Supporting information: Study protocol, Clinical study report
Time frame: Immediately following publication. No end date.
Access criteria: Data will be available to researchers who provide a methodologically sound proposal in order to achieve the aims mentioned in the approved proposal. Proposals should be directed to email : azizchattha@hotmail.com
Started Jan 2025 (actual). Primary completion is estimated for Jan 2027, 24 months after the start.
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University of Child Health Sciences and Children's Hospital, Lahore