Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: mucous fistula refeeding.
- Кому может быть актуально
- Состояния в реестре: Enterostomy. Базовые параметры: до 12 мес. · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австрия, Германия, Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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)
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое mucous fistula refeeding
Transfer of infants' own stool
Первичные конечные точки
- Time to full enteral feeds (hours) [Срок оценки: week 4 to week 12 daily]
Вторичные конечные точки (12)
- Time to first bowel movement [Срок оценки: Week 4 to week 12 daily]
- Thriving [Срок оценки: Week 1 to week 12 daily; follow-up (month 3, 6, 12)]
- Z-Score (standard deviation score) [Срок оценки: Week 1 to week 12 daily, follow-up (month 3, 6, 12)]
- Number of days of postoperative total parenteral nutrition (TPN) [Срок оценки: Week 2 to week 12 daily, follow-up (month 3, 6, 12)]
- Laboratory parameter indicating cholestasis [Срок оценки: Week 1 to week 12 daily, follow-up (month 3)]
- Assessment of adverse events (AEs) [Срок оценки: Week 1 to week 12 daily, follow-up (month 3, 6, 12)]
- Assessment of serious adverse events (SAEs) [Срок оценки: Week 1 to week 12 daily, follow-up (month 3, 6, 12)]
- Postoperative weight gain (g/d) [Срок оценки: week 4 to week 12]
- Central venous line (CVL) [Срок оценки: Week 1 to week 12]
- hospitalisation [Срок оценки: week 1 to week 12]
- jump in caliber [Срок оценки: week 5]
- Sodium resorption [Срок оценки: Week 1 to week 12 daily, follow-up (month 3)]
Критерии участия
Критерии включения
- Infants < 366 days,
- Ileostomy / Jejunostomy,
- double loop enterostomies and split enterostomies (with mucous fistula)
- 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
Критерии исключения
- resection of ileocecal valve,
- colostomy,
- small bowel atresia,
- multiple ostomies (more than just an enterostomy and a mucous fistula),
- chromosomal abnormalities (if known at the time of randomization),
- Hirschsprung's disease,
- participation in another drug-intervention study
- Intestinal perforation due to a hemodynamic heart defect
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Германия · 13 центров
- Universitätsklinik für Kinder- und Jugendmedizin Tübingen — Tübingen
- Städtisches Klinikum München GmbH/ Klinikum Schwabing — München
- Zentrum der Chirurgie, Klinik für Kinderchirurgie — Frankfurt am Main
- Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie — Hanover
- Hannover Medical School, Clinic for Pediatric Surgery — Hanover
- Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery — Witten
- Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie — Mainz
- Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie — Dresden
- … и ещё 5 центров
Австрия · 2 центра
- Universitätsklinik für Kinder- und Jugendchirurgie — Graz
- Universitätsklinik für Kinder- und Jugendheilkunde — Vienna
Нидерланды · 2 центра
- Amsterdam University Medical Centers — Amsterdam
- Erasmus University Medical Center Rotterdam — Rotterdam
Публикации
- Grosshennig A, Wiesner S, Hellfritsch J, Thome U, Knupfer M, Peter C, Metzelder M, Binder C, Wanz U, Flucher C, Brands BO, Mollweide A, Ludwikowski B, Koluch A, Scherer S, Gille C, Theilen TM, Rochwalsky U, Karpinski C, Schulze A, Schuster T, Weber F, Seitz G, Gesche J, Nissen M, Jager M, Koch A, Ure B, Madadi-Sanjani O, Lacher M. MUC-FIRE: Study protocol for a randomized multicenter open-label co PMID 36875554
Идентификаторы
NCT: NCT03469609 · MUC-FIRE