MUC-FIRE：一项随机多中心开放标签对照试验的研究方案，旨在表明黏液瘘再喂养可缩短从肠造口闭合到完全肠内喂养的时间。
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.
作者信息
Großhennig Anika, Wiesner Sören, Hellfritsch Juliane, Thome Ulrich, Knüpfer Matthias, Peter Corinna, Metzelder Martin, Binder Christoph, Wanz Ulrike, Flucher Christina, Brands Björn O, Mollweide Andreas, Ludwikowski Barbara, Koluch Anna, Scherer Simon, Gille Christian, Theilen Till-Martin, Rochwalsky Ulrich, Karpinski Christian, Schulze Annekatrin, Schuster Tobias, Weber Florian, Seitz Guido, Gesche Jens, Nissen Matthias, Jäger Maximilian, Koch Armin, Ure Benno, Madadi-Sanjani Omid, Lacher Martin
机构信息
Institute of Biostatistics, Hannover Medical School, Germany.
Department of Pediatric Surgery, University of Leipzig, Germany.
出版信息
Contemp Clin Trials Commun. 2023 Feb 20;32:101096. doi: 10.1016/j.conctc.2023.101096. eCollection 2023 Apr.
BACKGROUND
After enterostomy creation, the distal bowel to the ostomy is excluded from the physiologic passage of stool, nutrient uptake, and growth of this intestinal section. Those infants frequently require long-term parenteral nutrition, continued after enterostomy reversal due to the notable diameter discrepancy of the proximal and distal bowel. Previous studies have shown that mucous fistula refeeding (MFR) results in faster weight gain in infants. The aim of the randomized multicenter open-label controlled ous stula feeding ("") trial is to demonstrate that MFR between enterostomy creation and reversal reduces the time to full enteral feeds after enterostomy closure compared to controls, resulting in shorter hospital stay and less adverse effects of parenteral nutrition. A total of 120 infants will be included in the MUC-FIRE trial. Following enterostomy creation, infants will be randomized to either an intervention or a non-intervention group.In the intervention group, perioperative MFR between enterostomy creation and reversal will be performed. The control group receives standard care without MFR.The primary efficacy endpoint of the study is the time to full enteral feeds. Secondary endpoints include first postoperative bowel movement after stoma reversal, postoperative weight gain, and days of postoperative parenteral nutrition. In addition adverse events will be analyzed.
DISCUSSION
The MUC-FIRE trial will be the first prospective randomized trial to investigate the benefits and disadvantages of MFR in infants. The results of the trial are expected to provide an evidence-based foundation for guidelines in pediatric surgical centers worldwide.
TRIAL REGISTRATION
The trial has been registered at clinicaltrials.gov (number: NCT03469609, date of registration: March 19, 2018; last update: January 20, 2023, https://clinicaltrials.gov/ct2/show/NCT03469609?term=NCT03469609&draw=2&rank=1).
背景
造口术后，造口远端的肠段被排除在粪便的生理通道、营养吸收以及该肠段的生长过程之外。这些婴儿经常需要长期肠外营养，由于近端和远端肠段直径差异显著，在造口还纳术后仍需继续。既往研究表明，黏液瘘管再喂养（MFR）可使婴儿体重增加更快。随机多中心开放标签对照造瘘喂养（“”）试验的目的是证明，与对照组相比，造口形成与还纳之间进行MFR可减少造口关闭后完全肠内喂养的时间，从而缩短住院时间并减少肠外营养的不良反应。MUC-FIRE试验共纳入120名婴儿。造口术后，婴儿将被随机分为干预组或非干预组。干预组将在造口形成与还纳之间进行围手术期MFR。对照组接受不进行MFR的标准护理。该研究的主要疗效终点是完全肠内喂养的时间。次要终点包括造口还纳术后首次排便、术后体重增加以及术后肠外营养天数。此外，还将分析不良事件。
讨论
MUC-FIRE试验将是首个研究婴儿MFR利弊的前瞻性随机试验。该试验结果有望为全球儿科手术中心的指南提供循证基础。
试验注册
该试验已在clinicaltrials.gov注册（编号：NCT03469609，注册日期：2018年3月19日；最后更新日期：2023年1月20日，https://clinicaltrials.gov/ct/show/NCT03469609?term=NCT03469609&draw=2&rank=1）。
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