PDF(Pubmed)
Abstract：
UNASSIGNED: 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 MUCous FIstula REfeeding (\"MUC-FIRE\") 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. Methods/Design: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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).
摘要：
未经批准：创建肠造口术后，造口术的远端肠被排除在粪便的生理通道之外，营养吸收，和肠道的生长。这些婴儿经常需要长期的肠外营养，由于近端和远端肠的明显直径差异，在肠造口术逆转后继续。先前的研究表明，粘液瘘再喂养（MFR）会导致婴儿体重增加更快。随机多中心开放标签对照MUCousFistulaRefeding（“MUC-FIRE”）试验的目的是证明与对照组相比，肠造口创建和逆转之间的MFR减少了肠造口关闭后完全肠内喂养的时间。导致住院时间更短，肠外营养的不良反应更少。方法/设计：总共120名婴儿将被纳入MUC-FIRE试验。在创建肠造口后，婴儿将被随机分为干预组或非干预组.在干预组中，将进行肠造口创建和逆转之间的围手术期MFR。对照组接受无MFR的标准护理。该研究的主要功效终点是完全肠内喂养的时间。次要终点包括造口逆转后的首次术后排便，术后体重增加,和术后肠外营养的天数。此外,将分析不良事件。
UNASSIGNED：MUC-FIRE试验将是第一个研究婴儿MFR的利弊的前瞻性随机试验。该试验的结果有望为全球儿科外科中心的指南提供循证基础。
UNASSIGNED：该试验已在clinicaltrials.gov上注册（编号：NCT03469609，注册日期：2018年3月19日；最后更新：2023年1月20日，https://clinicaltrials.gov/ct2/show/NCT03469609？term=NCT03469609&d
UNASSIGNED：MUC-FIRE试验将是第一个研究婴儿MFR的利弊的前瞻性随机试验。该试验的结果有望为全球儿科外科中心的指南提供循证基础。
UNASSIGNED：该试验已在clinicaltrials.gov上注册（编号：NCT03469609，注册日期：2018年3月19日；最后更新：2023年1月20日，https://clinicaltrials.gov/ct2/show/NCT03469609？term=NCT03469609&d
