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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-15
SponsorUniversity of Child Health Sciences and Children's Hospital, Lahore

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children with colostomy between 1-15 years of age

Disqualifiers

Malnourished

Previous history of colostomy site anastomotic leakage

Trial design

Design model

Parallel

Treatments tested in this trial

  • No Mechanical Bowel Preparation

    Procedure/Surgery

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

  • Mechanical Bowel Preparation

    Procedure/Surgery

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group A Colostomy ReversalActive comparator 1 intervention
Group B: Group B Colostomy ReversalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5-10 days post operatively.
2

Wound infection

In this outcome variable, number of participants with infection at the site of colostomy reversal wound will be compared between both groups.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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