在食道切除术后使用鼻胃管的随机对照试验:动力试验的研究方案
Jakob Hedberg1, Magnus Sundbom1, David Edholm2
1Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
概括
在食道切除术后立即切除鼻胃管 (NG) 可能与常规使用一样安全. 这项试验调查了早期的NG管切除是否会影响食道癌症手术后患者的结果.
科学领域:
- 胃肠道手术 胃肠道手术
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 消化管癌的消化管切除术是复杂的,有各种各样的术后策略.
- 在食道切除术后使用鼻胃管 (NG) 会引起患者显著的不适.
- 在食道切除术后,对最佳NG管管理的证据有限.
研究的目的:
- 为了确定手术后立即去除NG管是否与常规的5天使用不劣.
- 为了评估NG管管理对食道切除术后的门泄漏的影响.
- 评估二次结果,包括肺部并发症和生活质量.
主要方法:
- 一个开放的,务实的,多中心随机对照试验 (RCT),涉及13个北欧中心.
- 包括患有局部晚期食道癌症,接受食道切除术并进行胃管重建的患者.
- 干预组:没有术后NG管;对照组:使用NG管5天. 主要终点: 解静脉性泄漏.
主要成果:
- 动力试验是第一个充足的动力多中心实用RCT关于这个主题.
- 包容性开始于2022年1月,在四个北欧国家获得了道德批准.
- 该试验被认为是安全的,安全委员会建议继续进行.
结论:
- 这项研究解决了关于术后NG管管理的证据的关键差距.
- 这些发现将为临床实践提供信息,并可能改善食道切除术后的患者舒适度.
- 这项试验为研究上部胃肠道癌症手术中的术后策略建立了坚实的框架.
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