Colostomy Clinical Trial
Official title:
Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.
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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Infantil de Mexico Federico Gomez | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Hospital Infantil de Mexico Federico Gomez |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgery Related Complications | Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage | up to 30 days |
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