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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02530346
Other study ID # HIM-2015-087
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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