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

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.

Study Overview

• Status: Unknown
• Conditions: Colostomy; Surgical Anastomosis
• Intervention / Treatment: Drug: Mechanical Bowel Preparation; Drug: No Mechanical Bowel Preparation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06720
    • Recruiting
    • Hospital Infantil de Mexico Federico Gomez
    • Contact: Emilio J Fernandez Portilla, MD; Phone Number: 2208 52289917; Email: drejfernandez@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Mechanical Bowel Preparation; 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; 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; Other Names: Nulitelly
EXPERIMENTAL: No Mechanical Bowel Preparation; Patients will not receive any preparation prior to surgery	Drug: No Mechanical Bowel Preparation; no enemas or oral laxatives will be given in this group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Infantil de Mexico Federico Gomez

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (ESTIMATE): August 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HIM-2015-087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO