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NCT Number: NCT06902116

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

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

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Key information

Conditions

Colostomy - Stoma Bowel Anastomosis Bowel Preparation

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Child Health Sciences, The Children's Hospital

Lahore, Punjab Province, 54600, Pakistan

Location status: Recruiting

Location contact

Aziz Ahmad Chattha, MBBS, FCPS

PRINCIPAL_INVESTIGATOR

Muhammad Z Shoukat, MBBS, FCPS

CONTACT

[email protected]

923126446646

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with colostomy between 1-15 years of age

Exclusion criteria

  • Malnourished
  • Previous history of colostomy site anastomotic leakage

Treatment and study plan

No Mechanical Bowel Preparation

Procedure

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

Mechanical Bowel Preparation

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aziz A Chattha, MBBS, FCPS

CONTACT

[email protected]

923215986466

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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