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

Colostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02530346
• Other study ID #: HIM-2015-087
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Hospital Infantil de Mexico Federico Gomez
• Contact: Emilio J Fernandez Portilla, MD
• Phone: 52289917
• Email: drejfernandez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Colostomy
• Surgical Anastomosis

Intervention

Drug:
• No Mechanical Bowel Preparation
no enemas or oral laxatives will be given in this group
• 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

Locations

Country	Name	City	State
Mexico	Hospital Infantil de Mexico Federico Gomez	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infantil de Mexico Federico Gomez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery Related Complications	Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage	up to 30 days