An interventional study of No Mechanical Bowel Preparation and Mechanical Bowel Preparation in Colostomy and Surgical Anastomosis, sponsored by Hospital Infantil de Mexico Federico Gomez. Status unknown at 1 site in Mexico. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2018-08-06.
Sponsored by Hospital Infantil de Mexico Federico Gomez · Not applicable, Interventional, and Treatment
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.
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.
Hospital Infantil de Mexico Federico Gomez is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Also known as: Nulitelly
Surgery Related Complications
Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage
Time frame: up to 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Hospital Infantil de Mexico Federico Gomez