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

Last updated: November 4, 2024
Sponsor: University of Leipzig
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

mucous fistula refeeding

Clinical Study ID

NCT03469609
MUC-FIRE
  • Ages < 12
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Infants < 366 days,

  2. Ileostomy / Jejunostomy,

  3. double loop enterostomies and split enterostomies (with mucous fistula)

  4. Signed written informed consent obtained by parents/legal guardians and willingnessof parents/legal guardians to comply with treatment and follow-up procedures oftheir child

Exclusion

Exclusion Criteria:

  1. resection of ileocecal valve,

  2. colostomy,

  3. small bowel atresia,

  4. multiple ostomies (more than just an enterostomy and a mucous fistula),

  5. chromosomal abnormalities (if known at the time of randomization),

  6. Hirschsprung's disease,

  7. participation in another drug-intervention study

  8. Intestinal perforation due to a hemodynamic heart defect

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: mucous fistula refeeding
Phase:
Study Start date:
June 18, 2018
Estimated Completion Date:
November 30, 2027

Study 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.

Connect with a study center

  • Universitätsklinik für Kinder- und Jugendchirurgie

    Graz, 8036
    Austria

    Active - Recruiting

  • Universitätsklinik für Kinder- und Jugendheilkunde

    Wien, 1090
    Austria

    Active - Recruiting

  • Universitätsklinik für Kinder- und Jugendmedizin Tübingen

    Tübingen, Baden-Württemberg 72076
    Germany

    Active - Recruiting

  • Städtisches Klinikum München GmbH/ Klinikum Schwabing

    München, Bayern 80804
    Germany

    Active - Recruiting

  • Zentrum der Chirurgie, Klinik für Kinderchirurgie

    Frankfurt, Hessen 60590
    Germany

    Terminated

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

    Hannover, Niedersachsen 30173
    Germany

    Active - Recruiting

  • Hannover Medical School, Clinic for Pediatric Surgery

    Hannover, Niedersachsen 30625
    Germany

    Active - Recruiting

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

    Witten, Nordrhein-Westfalen 58452
    Germany

    Active - Recruiting

  • Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie

    Dresden, Sachsen 01304
    Germany

    Terminated

  • University of Leipzig

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • University Hospital Augsburg, Clinic for Pediatric Surgery

    Augsburg, 86156
    Germany

    Active - Recruiting

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

    Hamburg, 20246
    Germany

    Site Not Available

  • University Hospital Marburg, Clinic for Pediatric Surgery

    Marburg, 35043
    Germany

    Active - Recruiting

  • Amsterdam University Medical Centers

    Amsterdam, 1000 GG
    Netherlands

    Active - Recruiting

  • Erasmus University Medical Center Rotterdam

    Rotterdam, 3015 CE
    Netherlands

    Active - Recruiting

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