Clinical trial NCT03469609: Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Enterostomy
Keywords: infants
necrotizing enterocolitis (NEC)
focal intestinal perforation (FIP)
enterostomy creation
bowel reanastomosis
enteral feeding
caloric intake
parenteral nutrition
complication rate
reduction of hospital expenses
length of hospital stay
refeeding
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: Hannover Medical School
First posted: 2018-03-19
Enrollment: 120
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, open-label, randomized, parallel group, controlled trial
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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 willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child

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

Primary outcomes:
measure: Time to full enteral feeds (hours)
timeFrame: week 4 to week 12 daily
Secondary outcomes:
measure: Time to first bowel movement
timeFrame: Week 4 to week 12 daily
measure: Thriving
timeFrame: Week 1 to week 12 daily; follow-up (month 3, 6, 12)
measure: Z-Score (standard deviation score)
timeFrame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
measure: Number of days of postoperative total parenteral nutrition (TPN)
timeFrame: Week 2 to week 12 daily, follow-up (month 3, 6, 12)
measure: Laboratory parameter indicating cholestasis
timeFrame: Week 1 to week 12 daily, follow-up (month 3)
measure: Assessment of adverse events (AEs)
timeFrame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
measure: Assessment of serious adverse events (SAEs)
timeFrame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
measure: Postoperative weight gain (g/d)
timeFrame: week 4 to week 12
measure: Central venous line (CVL)
timeFrame: Week 1 to week 12
measure: hospitalisation
timeFrame: week 1 to week 12
measure: jump in caliber
timeFrame: week 5
measure: Sodium resorption
timeFrame: Week 1 to week 12 daily, follow-up (month 3)
measure: Status of liver enzymes
timeFrame: Week 1 to week 12 daily, follow-up (month 3)
measure: Laboratory parameters
timeFrame: Week 1 to week 12 daily, follow-up (month 3)
measure: Time to full volume intake per day (in hours)
timeFrame: week 4 to week 12 daily
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinik für Kinder- und Jugendchirurgie
city: Wien
country: Austria
facility: Universitätsklinik für Kinder- und Jugendheilkunde
city: Tübingen
country: Germany
facility: Universitätsklinik für Kinder- und Jugendmedizin Tübingen
state: Baden-Württemberg
city: München
country: Germany
facility: Städtisches Klinikum München GmbH/ Klinikum Schwabing
state: Bayern
city: Frankfurt
country: Germany
facility: Zentrum der Chirurgie, Klinik für Kinderchirurgie
state: Hessen
city: Hannover
country: Germany
facility: Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie
state: Niedersachsen
city: Hannover
country: Germany
facility: Hannover Medical School, Clinic for Pediatric Surgery
state: Niedersachsen
city: Witten
country: Germany
facility: Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie
state: Sachsen
city: Leipzig
country: Germany
facility: University of Leipzig
state: Sachsen
city: Augsburg
country: Germany
facility: University Hospital Augsburg, Clinic for Pediatric Surgery
city: Hamburg
country: Germany
facility: Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]
city: Marburg
country: Germany
facility: University Hospital Marburg, Clinic for Pediatric Surgery
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center Rotterdam
Study officials:
affiliation: Hannover Medical School, Department of Pediatric Surgery
name: Omid Madadi-Sanjani, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leipzig, Department of Pediatric Surgery
name: Martin Lacher, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: