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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
| Hannover Medical School | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative mucous fistula refeeding | Experimental | Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure |
|
| No mucous fistula refeeding | No Intervention | No perioperative mucous fistula refeeding |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mucous fistula refeeding | Other | Transfer of infants' own stool |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| week 4 to week 12 daily |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Thriving |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Lacher, Prof. Dr. med. | Contact | +49-341-97 | 26400 | muc-fire-leipzig@medizin.uni-leipzig.de |
| Omid Madadi-Sanjani, PD Dr. med. | Contact | +49-176 | 20192676 | O.Madadi-Sanjani@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Omid Madadi-Sanjani, PD Dr. med. | University Medical Center Hamburg-Eppendorf (UKE), Department of Pediatric Surgery | Principal Investigator |
| Martin Lacher, Prof. Dr. med. | University of Leipzig, Department of Pediatric Surgery |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Kinder- und Jugendchirurgie | Recruiting | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36875554 | Derived | 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 controlled trial to show that MUCous FIstula REfeeding reduces the time from enterostomy closure to full enteral feeds. Contemp Clin Trials Commun. 2023 Feb 20;32:101096. doi: 10.1016/j.conctc.2023.101096. eCollection 2023 Apr. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2022 |
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Multicenter, open-label, randomized, parallel group, controlled trial
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Measurement of body weight
| 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)] | 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 | Week 2 to week 12 daily, follow-up (month 3, 6, 12) |
| Laboratory parameter indicating cholestasis | Measurement of conjugated Bilirubin (µmol/l) | Week 1 to week 12 daily, follow-up (month 3) |
| 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) |
| 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) |
| 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 |
| Central venous line (CVL) | duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines) | Week 1 to week 12 |
| hospitalisation | Length of hospital stay (days) | week 1 to week 12 |
| jump in caliber | Estimated ratio of the diameter of the two bowel loops which are anastomosed. | week 5 |
| Sodium resorption | Sodium in Urine (mmol/l) | 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) | Week 1 to week 12 daily, follow-up (month 3) |
| Laboratory parameters | Haemoglobin (g/dl) | 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).
| week 4 to week 12 daily |
| Universitätsklinik für Kinder- und Jugendheilkunde | Recruiting | Vienna | 1090 | Austria |
|
| Universitätsklinik für Kinder- und Jugendmedizin Tübingen | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
|
| Städtisches Klinikum München GmbH/ Klinikum Schwabing | Recruiting | München | Bavaria | 80804 | Germany |
|
| Zentrum der Chirurgie, Klinik für Kinderchirurgie | Terminated | Frankfurt am Main | Hesse | 60590 | Germany |
| Auf der Bult, Kinder- und Jugendkrankenhaus, Kinderchirurgie und Kinderurologie | Recruiting | Hanover | Lower Saxony | 30173 | Germany |
|
| Hannover Medical School, Clinic for Pediatric Surgery | Recruiting | Hanover | Lower Saxony | 30625 | Germany |
|
| Marien Hospital Witten, Ruhr-University Bochum, Department of Pediatric Surgery | Recruiting | Witten | North Rhine-Westphalia | 58452 | Germany |
|
| Universitätsmedizin Mainz, Klinik und Poliklinik für Kinderchirurgie | Withdrawn | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinderchirurgie | Terminated | Dresden | Saxony | 01304 | Germany |
| University of Leipzig | Recruiting | Leipzig | Saxony | 04103 | Germany |
|
| University Hospital Augsburg, Clinic for Pediatric Surgery | Recruiting | Augsburg | 86156 | Germany |
|
| Hamburg [University Hospital Hamburg Eppendorf/UKE & Altonaer Kinderkrankenhaus/AKK] | Not yet recruiting | Hamburg | 20246 | Germany |
|
| University Hospital Marburg, Clinic for Pediatric Surgery | Recruiting | Marburg | 35043 | Germany |
|
| Munich Clinic Harlaching | Recruiting | München | 81545 | Germany |
|
| Amsterdam University Medical Centers | Recruiting | Amsterdam | 1000 GG | Netherlands |
|
| Erasmus University Medical Center Rotterdam | Recruiting | Rotterdam | 3015 CE | Netherlands |
|
| Feb 28, 2023 |
| Prot_SAP_004.pdf |
| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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