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

NCT ID: NCT02530346

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2019-12-31

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.

Conditions

Colostomy; Surgical Anastomosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Mechanical Bowel Preparation

Intervention Type: DRUG

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

No Mechanical Bowel Preparation

Patients will not receive any preparation prior to surgery

Group Type: EXPERIMENTAL

No Mechanical Bowel Preparation

Intervention Type: DRUG

no enemas or oral laxatives will be given in this group

Interventions

No Mechanical Bowel Preparation

no enemas or oral laxatives will be given in this group

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Nulitelly

Eligibility 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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Infantil de Mexico Federico Gomez

OTHER

Sponsor Role: lead

Responsible Party

Emilio Fernandez Portilla

Pediatric Colorectal Surgery Attending

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Infantil de Mexico Federico Gomez

Mexico City, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Emilio J Fernandez Portilla, MD

Role: CONTACT

drejfernandez@gmail.com

52289917 ext. 2208

Facility Contacts

Emilio J Fernandez Portilla, MD

Role: primary

drejfernandez@gmail.com

52289917 ext. 2208

Other Identifiers

HIM-2015-087

Identifier Type: -

Identifier Source: org_study_id