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

Hospital Infantil de Mexico Federico Gomez

Status: Unknown

Conditions: Colostomy; Surgical Anastomosis

Treatments: Drug: No Mechanical Bowel Preparation; Drug: Mechanical Bowel Preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT02530346

HIM-2015-087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Mechanical Bowel Preparation

Active Comparator group

Description:

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

Treatment:

Drug: Mechanical Bowel Preparation

No Mechanical Bowel Preparation

Experimental group

Description:

Patients will not receive any preparation prior to surgery

Treatment:

Drug: No Mechanical Bowel Preparation