Actively Recruiting

Phase Not Applicable
Age: 1Year - 15Years
All Genders
NCT06902116

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

Led by University of Child Health Sciences and Children's Hospital, Lahore · Updated on 2025-03-30

80

Participants Needed

1

Research Sites

59 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with colostomy between 1-15 years of age
Not Eligible

You will not qualify if you...

  • Malnourished
  • Previous history of colostomy site anastomotic leakage

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Child Health Sciences, The Children's Hospital

Lahore, Punjab Province, Pakistan, 54600

Actively Recruiting

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Research Team

A

Aziz A Chattha, MBBS, FCPS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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