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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02530346

Enrollment

130

Registered

2015-08-21

Start date

2015-10-31

Completion date

2019-12-31

Last updated

2018-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colostomy, Surgical Anastomosis

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.

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.

Interventions

DRUGNo Mechanical Bowel Preparation

no enemas or oral laxatives will be given in this group

DRUGMechanical 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

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

Design outcomes

Primary

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

Countries

Mexico

Contacts

Primary ContactEmilio J Fernandez Portilla, MD

drejfernandez@gmail.com52289917

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026