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)

一项随机多中心开放标签对照试验表明，粘液瘘再喂养可缩短从肠造口闭合到完全肠内喂养的时间（MUCous FIstula REfeeding（“MUC-FIRE”）试验）

• 批准号: 316564369
• 负责人: Professor Dr. Martin Lacher
• 金额: --
• 依托单位: Klinik und Poliklinik für Kinderchirurgie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/316564369?language=en
• 关键词: randomized; multicenter; open; label; controlled

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 partenteral 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. Case reports and retrospective analyses show low complication rates and faster postoperative weight gain. 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 standard of care. Moreover, the side effects of parenteral nutrition may be reduced and the postoperative hospital care of infants undergoing ostomy closure shortened.

儿童肠造口可能出于不同的原因。在进行肠造口术期间，由于肠的远端部分（肠造口术之后的部分）不参与粪便循环，因此常规粪便转移被中断。因此，它不会促进肠内容物的吸收。因此，这些儿童需要额外的肠外营养。由于肠外营养的副作用，所有患者都应尽快恢复肠内营养。因此，世界各地的许多儿科外科中心在肠造口术后常规对以前未使用的肠道进行粘液瘘再喂养（MFR），因为病例报告和回顾性分析显示并发症发生率低且术后体重增加更快。然而，一些提供者回避这种方法，因为迄今为止仍然没有高质量的证据证明这种治疗的益处。病例报告和回顾性分析显示并发症发生率低，术后体重增加更快。本研究的目的是在一项随机、前瞻性试验中评估粘液瘘再喂养的效果。我们假设，与标准护理相比，肠造口术创建和肠造口术闭合之间的 MFR 减少了肠造口术闭合后完全肠内喂养的时间。此外，可以减少肠外营养的副作用，并缩短接受造口闭合的婴儿的术后住院护理时间。