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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02530346|
Recruitment Status : Recruiting
First Posted : August 21, 2015
Last Update Posted : August 6, 2018
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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
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
|Contact: Emilio J Fernandez Portilla, MD||52289917 ext firstname.lastname@example.org|
|Hospital Infantil de Mexico Federico Gomez||Recruiting|
|Mexico City, Mexico, 06720|
|Contact: Emilio J Fernandez Portilla, MD 52289917 ext 2208 email@example.com|