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

University of Leipzig

Status: Enrolling

Conditions: Enterostomy

Treatments: Other: mucous fistula refeeding

Study type: Interventional

Funder types: Other

Identifiers

NCT03469609

MUC-FIRE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Perioperative mucous fistula refeeding

Experimental group

Description:

Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure

Treatment:

Other: mucous fistula refeeding

No mucous fistula refeeding

No Intervention group

Description:

No perioperative mucous fistula refeeding