Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mucous fistula refeeding.
- Who it may be relevant to
- Registry conditions: Enterostomy. Basic parameters: up to 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
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 enterostomy) does not participate in the circulation of stool. Therefore it does not contribute to the resorption of enteral contents. As a consequence these children need additional parenteral nutrition. Due to the negative side-effects of parenteral nutrition all patients should return to enteral nutrition as soon as possible. Consequently, many pediatric surgical centers worldwide routinely perform mucous fistula refeeding (MFR) into the former unused bowel after enterostomy creation because case reports and retrospective analyses show low complication rates and faster postoperative weight gain. Several providers, however, shy away from this approach because to date there is still no high quality evidence for the benefit of this Treatment.The aim of this study is to assess the effects of mucous fistula refeeding in a randomized, prospective trial. We hypothesize that MFR between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to the group without refilling. Moreover, the side effects of parenteral nutrition may be reduced and the postoperative hospital care of infants undergoing ostomy closure shortened.
Interventions
- Other mucous fistula refeeding
Transfer of infants' own stool
Primary outcome measures
- Time to full enteral feeds (hours) [Time frame: week 4 to week 12 daily]
Secondary outcome measures (12)
- Time to first bowel movement [Time frame: Week 4 to week 12 daily]
- Thriving [Time frame: Week 1 to week 12 daily; follow-up (month 3, 6, 12)]
- Z-Score (standard deviation score) [Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)]
- Number of days of postoperative total parenteral nutrition (TPN) [Time frame: Week 2 to week 12 daily, follow-up (month 3, 6, 12)]
- Laboratory parameter indicating cholestasis [Time frame: Week 1 to week 12 daily, follow-up (month 3)]
- Assessment of adverse events (AEs) [Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)]
- Assessment of serious adverse events (SAEs) [Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)]
- Postoperative weight gain (g/d) [Time frame: week 4 to week 12]
- Central venous line (CVL) [Time frame: Week 1 to week 12]
- hospitalisation [Time frame: week 1 to week 12]
- jump in caliber [Time frame: week 5]
- Sodium resorption [Time frame: Week 1 to week 12 daily, follow-up (month 3)]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 13 centers
- Universitätsklinik für Kinder- und Jugendmedizin Tübingen — Tübingen
- Städtisches Klinikum München GmbH/ Klinikum Schwabing — München
- Zentrum der Chirurgie, Klinik für Kinderchirurgie — Frankfurt am Main
- Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie — Hanover
- Hannover Medical School, Clinic for Pediatric Surgery — Hanover
- Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery — Witten
- Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie — Mainz
- Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie — Dresden
- … and 5 more centers
Austria · 2 centers
- Universitätsklinik für Kinder- und Jugendchirurgie — Graz
- Universitätsklinik für Kinder- und Jugendheilkunde — Vienna
Netherlands · 2 centers
- Amsterdam University Medical Centers — Amsterdam
- Erasmus University Medical Center Rotterdam — Rotterdam
Publications
- Grosshennig A, Wiesner S, Hellfritsch J, Thome U, Knupfer M, Peter C, Metzelder M, Binder C, Wanz U, Flucher C, Brands BO, Mollweide A, Ludwikowski B, Koluch A, Scherer S, Gille C, Theilen TM, Rochwalsky U, Karpinski C, Schulze A, Schuster T, Weber F, Seitz G, Gesche J, Nissen M, Jager M, Koch A, Ure B, Madadi-Sanjani O, Lacher M. MUC-FIRE: Study protocol for a randomized multicenter open-label co PMID 36875554
Identifiers
NCT: NCT03469609 · MUC-FIRE