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手术前的机械肠道制备和预防性口服抗生素对于接受选择性结肠直肠手术的儿科患者:随机对照可行性试验的方案

Daniel Briatico^1,2, Helene Flageole^1,2, Noora Al-Shahwani^1,3

¹McMaster Pediatric Surgery Research Collaborative, McMaster University, Hamilton, ON, Canada.

Pilot and feasibility studies

|May 25, 2024

概括

这项研究评估了对小儿结直肠手术术术前肠道准备试验的可行性. 它探讨了口服抗生素和机械肠道准备,以减少儿童手术部位感染.

科学领域:

儿科手术儿科手术
传染性疾病传染性疾病
临床试验设计临床试验设计

背景情况:

手术后感染是儿科结直肠外科手术的一个重要问题.
与成年人相比,儿童手术前肠道准备的证据有限.
在儿科患者中,口服抗生素和机械肠道制备的联合疗效尚不确定.

研究的目的:

确定一项随机对照试验 (RCT) 的可行性,用于在儿科结直肠外科手术中进行术前肠道准备.
评估口服抗生素的疗效,与或没有机械肠道制备,在减少术后感染.
为了告知一个更大,多中心试验的设计.

主要方法:

一个可行性RCT,涉及3个月至18岁的参与者接受选择性结直肠手术.
参与者被随机分为三个组:口服抗生素,口服抗生素加上机械肠道制备或标准护理.
可行性结果包括招募率,协议遵守率和不良事件;二次结果评估感染率和并发症.

主要成果:

本节不适用,因为摘要描述了可行性研究,而不是结果.

结论:

这项可行性试验的成功完成将使更大规模的多中心研究成为可能.
这些发现将指导儿童结直肠手术最佳手术前肠道准备策略的评估.

关键词:

抗生素抗生素是一种抗生素.结肠直肠外科手术是什么意思机械肠道制备机械肠道制备儿科儿科儿科手术部位感染的感染.

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