Comparison of Outcome of Three Days Bowel Preparation vs No Bowel Preparation in Patients of Colostomy Reversal

March 27, 2025 updated by: Aziz Ahmad Chattha, University of Child Health Sciences and Children's Hospital, Lahore

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54600
        • Recruiting
        • University of Child Health Sciences, The Children's Hospital
        • Contact:
        • Principal Investigator:
          • Aziz Ahmad Chattha, MBBS, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children with colostomy between 1-15 years of age

Exclusion Criteria:

  • Malnourished
  • Previous history of colostomy site anastomotic leakage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A Colostomy Reversal
Patients in this group will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
Procedure: No Mechanical Bowel Preparation
In this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
Active Comparator: Group B Colostomy Reversal
Patients in this group will receive 3 days bowel preparation prior to undergoing colostomy reversal.
Procedure: Mechanical Bowel Preparation
In this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic Leakage
Time Frame: 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.
5-10 days post operatively.
Wound infection
Time Frame: 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.
At 7 days after surgery and then at 30 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Child Health Sciences and Children's Hospital, Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 1038/CH-UCHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication after deidentification (text, table, figures and appendices)

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bowel Preparation

Clinical Trials on No Mechanical Bowel Preparation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe