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RecruitingNot ApplicableNCT03469609

Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)

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)

Sponsor

University of Leipzig

Enrollment

120 participants

Start Date

Jun 18, 2018

Study Type

INTERVENTIONAL

Conditions

Enterostomy

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

Max Age: 12 Months

Inclusion Criteria4

  • 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 Criteria8

  • 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
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Interventions

OTHERmucous fistula refeeding

Transfer of infants' own stool

Locations(17)

Universitätsklinik für Kinder- und Jugendchirurgie

Graz, Austria

Universitätsklinik für Kinder- und Jugendheilkunde

Vienna, Austria

Universitätsklinik für Kinder- und Jugendmedizin Tübingen

Tübingen, Baden-Wurttemberg, Germany

Städtisches Klinikum München GmbH/ Klinikum Schwabing

München, Bavaria, Germany

Zentrum der Chirurgie, Klinik für Kinderchirurgie

Frankfurt am Main, Hesse, Germany

Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie

Hanover, Lower Saxony, Germany

Hannover Medical School, Clinic for Pediatric Surgery

Hanover, Lower Saxony, Germany

Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery

Witten, North Rhine-Westphalia, Germany

Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie

Mainz, Rhineland-Palatinate, Germany

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie

Dresden, Saxony, Germany

University of Leipzig

Leipzig, Saxony, Germany

University Hospital Augsburg, Clinic for Pediatric Surgery

Augsburg, Germany

Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]

Hamburg, Germany

University Hospital Marburg, Clinic for Pediatric Surgery

Marburg, Germany

Munich Clinic Harlaching

München, Germany

Amsterdam University Medical Centers

Amsterdam, Netherlands

Erasmus University Medical Center Rotterdam

Rotterdam, Netherlands

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NCT03469609

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