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

Enterostomy Clinical Trial

— MUC-FIRE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03469609
• Other study ID #: MUC-FIRE
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: University of Leipzig
• Contact: Martin Lacher, Prof. Dr.
• Phone: +49-341-97
• Email: muc-fire-leipzig[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Enterostomy
• Fistula

Intervention

Other:
• mucous fistula refeeding
Transfer of infants' own stool

Locations

Country	Name	City	State
Austria	Universitätsklinik für Kinder- und Jugendchirurgie	Graz
Austria	Universitätsklinik für Kinder- und Jugendheilkunde	Wien
Germany	University Hospital Augsburg, Clinic for Pediatric Surgery	Augsburg
Germany	Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie	Dresden	Sachsen
Germany	Zentrum der Chirurgie, Klinik für Kinderchirurgie	Frankfurt	Hessen
Germany	Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK]	Hamburg
Germany	Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie	Hannover	Niedersachsen
Germany	Hannover Medical School, Clinic for Pediatric Surgery	Hannover	Niedersachsen
Germany	University of Leipzig	Leipzig	Sachsen
Germany	Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie	Mainz	Rheinland-Pfalz
Germany	University Hospital Marburg, Clinic for Pediatric Surgery	Marburg
Germany	Städtisches Klinikum München GmbH/ Klinikum Schwabing	München	Bayern
Germany	Universitätsklinik für Kinder- und Jugendmedizin Tübingen	Tübingen	Baden-Württemberg
Germany	Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery	Witten	Nordrhein-Westfalen
Netherlands	Amsterdam University Medical Centers	Amsterdam
Netherlands	Erasmus University Medical Center Rotterdam	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
University of Leipzig	German Research Foundation, Hannover Medical School

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to full enteral feeds (hours)	Time to full feeds (hours), defined as time to actual enteral intake of the age-dependent caloric requirements per day (defined as 90 or 120kcal/kg/24h) for at least 24 hours and a concomitant reduction of parenteral fluids to <20ml/kg/24h.; The nutrition aim is 120 kcal/kg/24h for premature infants with a birth weight < 1000g or premature infants with a birth weight = 1000g and mother's gestation week at birth before 37+0.; The nutrition aim is 90 kcal/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.	week 4 to week 12 daily
Secondary	Time to first bowel movement	Cleaning and changing of infants diapers will be performed according to a fixed schedule in order to uniformly document the time to first bowel movement	Week 4 to week 12 daily
Secondary	Thriving	Measurement of body weight	Week 1 to week 12 daily; follow-up (month 3, 6, 12)
Secondary	Z-Score (standard deviation score)	Measurement of weight [weight for age, World Health Organization (WHO)]	Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Secondary	Number of days of postoperative total parenteral nutrition (TPN)	Calculation of days of postoperative TPN starts on the day of operation and ends on the day of full enteral nutrition	Week 2 to week 12 daily, follow-up (month 3, 6, 12)
Secondary	Laboratory parameter indicating cholestasis	Measurement of conjugated Bilirubin (µmol/l)	Week 1 to week 12 daily, follow-up (month 3)
Secondary	Assessment of adverse events (AEs)	Adverse events will be collected by the investigator either based on the information provided spontaneously by the parents of patient or evaluated by non-suggestive questions.	Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Secondary	Assessment of serious adverse events (SAEs)	Adverse events will be collected by the investigator either based on the information provided spontaneously by the parents of patient or evaluated by non-suggestive questions.	Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Secondary	Postoperative weight gain (g/d)	Weight gain during the subsequent 5 days after reaching the primary endpoint following enterostomy closure	week 4 to week 12
Secondary	Central venous line (CVL)	duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines)	Week 1 to week 12
Secondary	hospitalisation	Length of hospital stay (days)	week 1 to week 12
Secondary	jump in caliber	Estimated ratio of the diameter of the two bowel loops which are anastomosed.	week 5
Secondary	Sodium resorption	Sodium in Urine (mmol/l)	Week 1 to week 12 daily, follow-up (month 3)
Secondary	Status of liver enzymes	Gamma-Glutamyltransferase (GGT) , Alanine-Aminotransferase (ALT) , Aspartate-Aminotransferase (AST) (µkat/l)	Week 1 to week 12 daily, follow-up (month 3)
Secondary	Laboratory parameters	Haemoglobin (g/dl)	Week 1 to week 12 daily, follow-up (month 3)
Secondary	Time to full volume intake per day (in hours)	Time to full age-dependent volume intake per day (defined as 150ml/kg/24h for premature infants and 120ml/kg/24h for mature born infants as well as corrected mature infants) (in hours).; The volume aim is 150 ml/kg/24h for premature infants with a birth weight < 1000g or premature infants with a birth weight = 1000g and mother's gestation week at birth before 37+0.; The volume aim is 120 ml/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.	week 4 to week 12 daily