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

Sponsor

Hospital Infantil de Mexico Federico Gomez (Other)

Overall Status

Unknown status

CT.gov ID

NCT02530346

Collaborator

(none)

130

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colostomy Surgical Anastomosis	Drug: No Mechanical Bowel Preparation Drug: Mechanical Bowel Preparation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Surgery Related Complications [up to 30 days]
Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Infantil de Mexico Federico Gomez	Mexico City		Mexico	06720

Sponsors and Collaborators

Hospital Infantil de Mexico Federico Gomez

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emilio Fernandez Portilla, Pediatric Colorectal Surgery Attending, Hospital Infantil de Mexico Federico Gomez

ClinicalTrials.gov Identifier:

NCT02530346

Other Study ID Numbers:

HIM-2015-087

First Posted:

Aug 21, 2015

Last Update Posted:

Aug 6, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Aug 6, 2018