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

NCT06902116 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-03-30

No results posted yet for this study

Summary

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

  • Colostomy - Stoma
  • Bowel Preparation
  • BOWEL ANASTOMOSIS

Interventions

PROCEDURE

No Mechanical Bowel Preparation

In this group patients will not receive any mechanical 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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2026-01-31
Completion
2026-03-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06902116 on ClinicalTrials.gov