Comparison of Outcome of Three Days Bowel Preparation vs No Bowel Preparation in Patients of Colostomy Reversal
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Mechanical Bowel Preparation, Mechanical Bowel Preparation.
- Who it may be relevant to
- Registry conditions: Colostomy - Stoma, Bowel Preparation, BOWEL ANASTOMOSIS. Basic parameters: 1 year — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure No Mechanical Bowel Preparation
In this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal. - Procedure Mechanical Bowel Preparation
In this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal.
Primary outcome measures
- Anastomotic Leakage [Time frame: 5-10 days post operatively.]
- Wound infection [Time frame: At 7 days after surgery and then at 30 days after surgery.]
Eligibility criteria
Inclusion criteria
- Children with colostomy between 1-15 years of age
Exclusion criteria
- Malnourished
- Previous history of colostomy site anastomotic leakage
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- University of Child Health Sciences, The Children's Hospital — Lahore
Publications
- 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
- 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
Identifiers
NCT: NCT06902116 · 1038/CH-UCHS