Status:
RECRUITING
Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
German Research Foundation
Hannover Medical School
Conditions:
Enterostomy
Eligibility:
All Genders
Up to 12 years
Phase:
NA
Brief Summary
The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closur...
Detailed Description
Enterostomies in children may be created for different reasons. During the presence of an enterostomy the regular stool transfer is interrupted as the distal part of the bowel (the part following the ...
Eligibility Criteria
Inclusion
- Infants \< 366 days,
- Ileostomy / Jejunostomy,
- double loop enterostomies and split enterostomies (with mucous fistula)
- Signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child
Exclusion
- resection of ileocecal valve,
- colostomy,
- small bowel atresia,
- multiple ostomies (more than just an enterostomy and a mucous fistula),
- chromosomal abnormalities (if known at the time of randomization),
- Hirschsprung's disease,
- participation in another drug-intervention study
- Intestinal perforation due to a hemodynamic heart defect
Key Trial Info
Start Date :
June 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03469609
Start Date
June 18 2018
End Date
November 1 2027
Last Update
November 5 2024
Active Locations (16)
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1
Universitätsklinik für Kinder- und Jugendchirurgie
Graz, Austria, 8036
2
Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, Austria, 1090
3
Universitätsklinik für Kinder- und Jugendmedizin Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076
4
Städtisches Klinikum München GmbH/ Klinikum Schwabing
München, Bavaria, Germany, 80804