A Randomized Multicenter Open-label Controlled Trial to Show That Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (MUCous FIstula REfeeding (MUC-FIRE) Trial)
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 closure compared to standard of care.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Austria
Universitätsklinik für Kinder- und Jugendchirurgie
RECRUITING
Graz
Universitätsklinik für Kinder- und Jugendheilkunde
RECRUITING
Vienna
Germany
University Hospital Augsburg, Clinic for Pediatric Surgery
RECRUITING
Augsburg
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie
TERMINATED
Dresden
Zentrum der Chirurgie, Klinik für Kinderchirurgie
TERMINATED
Frankfurt Am Main
Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]
NOT_YET_RECRUITING
Hamburg
Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie
RECRUITING
Hanover
Hannover Medical School, Clinic for Pediatric Surgery
RECRUITING
Hanover
University of Leipzig
RECRUITING
Leipzig
Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie
WITHDRAWN
Mainz
University Hospital Marburg, Clinic for Pediatric Surgery
RECRUITING
Marburg
Munich Clinic Harlaching
RECRUITING
München
Städtisches Klinikum München GmbH/ Klinikum Schwabing
RECRUITING
München
Universitätsklinik für Kinder- und Jugendmedizin Tübingen
RECRUITING
Tübingen
Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery
RECRUITING
Witten
Netherlands
Amsterdam University Medical Centers
RECRUITING
Amsterdam
Erasmus University Medical Center Rotterdam
RECRUITING
Rotterdam
Contact Information
Primary
Martin Lacher, Prof. Dr. med.
muc-fire-leipzig@medizin.uni-leipzig.de
+49-341-97
Backup
Omid Madadi-Sanjani, PD Dr. med.
O.Madadi-Sanjani@uke.de
+49-176
Time Frame
Start Date: 2018-06-18
Estimated Completion Date: 2027-12
Participants
Target number of participants: 120
Treatments
Experimental: Perioperative mucous fistula refeeding
Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure
No_intervention: No mucous fistula refeeding
No perioperative mucous fistula refeeding
Authors
Related Therapeutic Areas
Sponsors
Collaborators: German Research Foundation, Hannover Medical School
Leads: University of Leipzig