Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.

Study Overview
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Brief Summary
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This study will help determine wether mechanical bowel preparation before a colostomy closure is necessary in pediatric population, in order to avoid surgery related complications (surgical site infection and anastomosis leakage). Half of the population will go through the mechanical bowel prep before colostomy closure and the other half won´t. Complications rate will be compared among both groups.

Detailed Description
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Mechanical bowel preparation is based on administering osmotic laxatives and enemas through the stomas, in order to diminish solid stool and bacterial load on the colon prior to a colostomy takedown. This was thought to decrease the surgery related complications. However mechanical bowel preparation can cause discomfort in patients as well as other complications like hydro electrolyte imbalance. Studies in adult population have shown that there is not a significant difference in the presence of surgery related complications in patients that received bowel prep and those who did not. There is not enough evidence in pediatric patients that this affirmation is also true.

Official Title
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Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.

Conditions
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Colostomy, Surgical Anastomosis

Intervention / Treatment
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* Drug: No Mechanical Bowel Preparation
* Drug: Mechanical Bowel Preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients who are to be submitted to a colostomy closure Exclusion Criteria: patients with more than 3 abdominal surgeries patients with primary or acquired immunodeficiencies (including malnourishment) Patients in which the distal intestine is closed in a Hartmann´s pouch

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mechanical Bowel Preparation<br>Patients will receive enteric polyethylene glycol at 100 ml/kg/dose during 4 hours, and up to 3 times, prior to surgery. Enemas with normal saline 20 ml/kg/do will be administered through the stomas 3 times a day | Drug: Mechanical Bowel Preparation<br>* oral laxatives (polyethylenglycol at 100 ml/kg/dose for up to 3 times) and stoma enemas (20mlkgdo of normal saline 3 times a day) will be prescribed<br>* Other names: Nulitelly;|
| Experimental: No Mechanical Bowel Preparation<br>Patients will not receive any preparation prior to surgery | Drug: No Mechanical Bowel Preparation<br>* no enemas or oral laxatives will be given in this group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery Related Complications | Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage | up to 30 days |