Status:
COMPLETED
Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO)
Lead Sponsor:
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Low Anterior resection with total mesorectal excision and diversion loop ileostomy is a gold standard surgical treatment in rectal cancer. Ileostomy reversal performed in a second stage carries a hig...
Eligibility Criteria
Inclusion
- Patients over 18 years of age
- Patients waiting for an elective ileostomy reversal after Rectal cancer surgical treatment
Exclusion
- Inflammatory bowel disease
- Abnormal preoperative findings trough rectoscopy or CT-enema scan that precluded a safe ileostomy closure
- Ileal pouch, poor treatment compliance
- Pregnancy or lactation
- Unwillingness to use adequate contraception throughout the study period
- Combined surgeries
- The impossibility to understand the informed consent.
Key Trial Info
Start Date :
December 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2016
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04795180
Start Date
December 10 2013
End Date
June 21 2016
Last Update
March 12 2021
Active Locations (1)
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1
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Spain, 17001