Comparison of Outcome of Three Days Bowel Preparation vs No Bowel Preparation in Patients of Colostomy Reversal
NCT ID: NCT06902116
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-01-08
2026-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A Colostomy Reversal
Patients in this group will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
No Mechanical Bowel Preparation
In this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
Group B Colostomy Reversal
Patients in this group will receive 3 days bowel preparation prior to undergoing colostomy reversal.
Mechanical Bowel Preparation
In this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal.
Interventions
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No Mechanical Bowel Preparation
In this group patients will not receive any mechanical bowel preparation prior to undergoing colostomy reversal.
Mechanical Bowel Preparation
In this group patients will receive 3 days mechanical bowel preparation prior to undergoing colostomy reversal.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous history of colostomy site anastomotic leakage
1 Year
15 Years
ALL
No
Sponsors
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University of Child Health Sciences and Children's Hospital, Lahore
OTHER
Responsible Party
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Aziz Ahmad Chattha
Senior Registrar
Locations
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University of Child Health Sciences, The Children's Hospital
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1038/CH-UCHS
Identifier Type: -
Identifier Source: org_study_id
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