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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Transfer of infants' own stool
Universitätsklinik für Kinder- und Jugendchirurgie
Graz, Austria
RECRUITINGTime 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. 1. 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. 2. The nutrition aim is 90 kcal/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.
Time frame: week 4 to week 12 daily
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
Time frame: Week 4 to week 12 daily
Thriving
Measurement of body weight
Time frame: Week 1 to week 12 daily; follow-up (month 3, 6, 12)
Z-Score (standard deviation score)
Measurement of weight \[weight for age, World Health Organization (WHO)\]
Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
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
Time frame: Week 2 to week 12 daily, follow-up (month 3, 6, 12)
Laboratory parameter indicating cholestasis
Measurement of conjugated Bilirubin (µmol/l)
Time frame: Week 1 to week 12 daily, follow-up (month 3)
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Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, Austria
RECRUITINGUniversitätsklinik für Kinder- und Jugendmedizin Tübingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGStädtisches Klinikum München GmbH/ Klinikum Schwabing
München, Bavaria, Germany
RECRUITINGZentrum der Chirurgie, Klinik für Kinderchirurgie
Frankfurt am Main, Hesse, Germany
TERMINATEDAuf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie
Hanover, Lower Saxony, Germany
RECRUITINGHannover Medical School, Clinic for Pediatric Surgery
Hanover, Lower Saxony, Germany
RECRUITINGMarien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery
Witten, North Rhine-Westphalia, Germany
RECRUITINGUniversitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie
Mainz, Rhineland-Palatinate, Germany
WITHDRAWNUniversitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie
Dresden, Saxony, Germany
TERMINATED...and 6 more locations
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.
Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
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.
Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Postoperative weight gain (g/d)
Weight gain during the subsequent 5 days after reaching the primary endpoint following enterostomy closure
Time frame: week 4 to week 12
Central venous line (CVL)
duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines)
Time frame: Week 1 to week 12
hospitalisation
Length of hospital stay (days)
Time frame: week 1 to week 12
jump in caliber
Estimated ratio of the diameter of the two bowel loops which are anastomosed.
Time frame: week 5
Sodium resorption
Sodium in Urine (mmol/l)
Time frame: Week 1 to week 12 daily, follow-up (month 3)
Status of liver enzymes
Gamma-Glutamyltransferase (GGT) , Alanine-Aminotransferase (ALT) , Aspartate-Aminotransferase (AST) (µkat/l)
Time frame: Week 1 to week 12 daily, follow-up (month 3)
Laboratory parameters
Haemoglobin (g/dl)
Time frame: Week 1 to week 12 daily, follow-up (month 3)
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). 1. 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. 2. The volume aim is 120 ml/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.
Time frame: week 4 to week 12 daily