NCT02530346

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Hospital Infantil de Mexico Federico Gomez · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	No Mechanical Bowel Preparation	no enemas or oral laxatives will be given in this group
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

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2015-08-21
• Last updated: 2018-08-06

Locations

1 site across 1 country: Mexico