Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2015
CompletedFirst Posted
Study publicly available on registry
August 21, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 6, 2018
August 1, 2018
4.2 years
August 19, 2015
August 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Surgery Related Complications
Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage
up to 30 days
Study Arms (2)
Mechanical Bowel Preparation
ACTIVE COMPARATORPatients 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
No Mechanical Bowel Preparation
EXPERIMENTALPatients will not receive any preparation prior to surgery
Interventions
no enemas or oral laxatives will be given in this group
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
Eligibility Criteria
You may qualify if:
- Pediatric patients who are to be submitted to a colostomy closure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Infantil de Mexico Federico Gomez
Mexico City, 06720, Mexico
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric Colorectal Surgery Attending
Study Record Dates
First Submitted
August 19, 2015
First Posted
August 21, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
August 6, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share