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

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

Status: Enrolling

Conditions: Colostomy - Stoma; BOWEL ANASTOMOSIS; Bowel Preparation

Treatments: Procedure: Mechanical Bowel Preparation; Procedure: No Mechanical Bowel Preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT06902116

1038/CH-UCHS

Details and patient eligibility

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

Enrollment: 80 estimated patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children with colostomy between 1-15 years of age

Exclusion criteria

• Malnourished
• Previous history of colostomy site anastomotic leakage

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group A Colostomy Reversal

Active Comparator group

Description:

Patients in this group will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.

Treatment:

Procedure: No Mechanical Bowel Preparation

Group B Colostomy Reversal

Active Comparator group

Description:

Patients in this group will receive 3 days bowel preparation prior to undergoing colostomy reversal.

Treatment:

Procedure: Mechanical Bowel Preparation