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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02530346
Recruitment Status : Unknown
Verified August 2018 by Emilio Fernandez Portilla, Hospital Infantil de Mexico Federico Gomez.
Recruitment status was:  Recruiting
First Posted : August 21, 2015
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Emilio Fernandez Portilla, Hospital Infantil de Mexico Federico Gomez

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019
Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Surgery Related Complications [ Time Frame: up to 30 days ]
    Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530346


Contacts
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Contact: Emilio J Fernandez Portilla, MD 52289917 ext 2208 drejfernandez@gmail.com

Locations
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Mexico
Hospital Infantil de Mexico Federico Gomez Recruiting
Mexico City, Mexico, 06720
Contact: Emilio J Fernandez Portilla, MD    52289917 ext 2208    drejfernandez@gmail.com   
Sponsors and Collaborators
Hospital Infantil de Mexico Federico Gomez
More Information
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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: August 21, 2015    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No