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

NCT06902116 | Recruiting DMC

• 1 other identifier: 1038/CH-UCHS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 1.Anastomotic leakage
2. 2.Hospital Stay
3. 3.Wound infection

Conditions

Colostomy - Stoma; Bowel Preparation; BOWEL ANASTOMOSIS

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At 7 days after surgery and then at 30 days after surgery.

Study Arms (2)

Group A Colostomy Reversal

ACTIVE COMPARATOR

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

Procedure: No Mechanical Bowel Preparation

Group B Colostomy Reversal

ACTIVE COMPARATOR

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

Procedure: Mechanical Bowel Preparation

Interventions

No Mechanical Bowel Preparation PROCEDURE

In this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.

Group A Colostomy Reversal

Mechanical Bowel Preparation PROCEDURE

In this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal.

Group B Colostomy Reversal

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with colostomy between 1-15 years of age

You may not qualify if:

• Malnourished
• Previous history of colostomy site anastomotic leakage

Sponsors & Collaborators

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

Study Sites (1)

University of Child Health Sciences, The Children's Hospital

Lahore, Punjab Province, 54600, Pakistan

RECRUITING

Related Publications (2)

• Cavusoglu YH, Karaman A, Afsarlar CE, Karaman I, Erdogan D, Ozguner IF. Ostomy Closures in Children: Variations in Perioperative Care Do Not Change the Outcome. Indian J Surg. 2015 Dec;77(Suppl 3):1131-6. doi: 10.1007/s12262-015-1212-0. Epub 2015 Jan 19.

  PMID: 27011524 BACKGROUND

• Ares GJ, Helenowski I, Hunter CJ, Madonna M, Reynolds M, Lautz T. Effect of preadmission bowel preparation on outcomes of elective colorectal procedures in young children. J Pediatr Surg. 2018 Apr;53(4):704-707. doi: 10.1016/j.jpedsurg.2017.03.060. Epub 2017 Mar 30.

  PMID: 28433362 BACKGROUND

Central Study Contacts

Aziz A Chattha, MBBS, FCPS

CONTACT

923215986466; azizchattha@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: March 30, 2025
• Study Start: January 8, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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

Locations

PA (1)