Colostomy - Stoma, Bowel Preparation, BOWEL ANASTOMOSIS
Conditions
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. Anastomotic leakage 2. Hospital Stay 3. Wound infection
Interventions
PROCEDUREMechanical Bowel Preparation
In this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal.
PROCEDURENo Mechanical Bowel Preparation
In this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
Sponsors
University of Child Health Sciences and Children's Hospital, Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
1 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Children with colostomy between 1-15 years of age
Exclusion criteria
* Malnourished * Previous history of colostomy site anastomotic leakage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic Leakage | 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. |
| Wound infection | 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. |
Countries
Pakistan
Contacts
Primary ContactAziz A Chattha, MBBS, FCPS
Outcome results
None listed