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经口内镜下肌切开术(POEM)治疗食管动力障碍时,横向与纵向黏膜切口:一项随机试验。

Transverse versus longitudinal mucosal incision during POEM for esophageal motility disorders: a randomized trial.

机构信息

Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.

Department of Anaesthesiology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.

出版信息

Surg Endosc. 2024 Sep;38(9):5053-5059. doi: 10.1007/s00464-024-11027-y. Epub 2024 Jul 15.

DOI:10.1007/s00464-024-11027-y
PMID:39009726
Abstract

BACKGROUND

Longitudinal incision is the commonly used incision for entry into the submucosal space during peroral endoscopic myotomy (POEM) for esophageal motility disorders. Transverse incision is another alternative for entry and retrospective data suggest it has less operative time and chance of gas-related events.

METHODS

This was a single-center, randomized trial conducted at a tertiary care hospital. Patients undergoing POEM for esophageal motility disorders were randomized into group A (longitudinal incision) and group B (transverse incision). The primary objective was to compare the time needed for entry into the submucosal space. The secondary objectives were to compare the time needed to close the incision, number of clips required to close the incision, and development of gas-related events. The sample size was calculated as for a non-inferiority design using Kelsey method.

RESULTS

Sixty patients were randomized (30 in each group). On comparing the 2 types of incisions, there was no difference in entry time [3 (2, 5) vs 2 (1.75, 5) min, p = 0.399], closure time [7 (4, 13.5) vs 9 (6.75, 19) min, p = 0.155], and number of clips needed for closure [4 (4, 6) vs 5 (4, 7), p = 0.156]. Additionally, the gas-related events were comparable between the 2 groups (capnoperitoneum needing aspiration-5 vs 2, p = 0.228, and development of subcutaneous emphysema-3 vs 1, p = 0.301).

CONCLUSION

This randomized trial shows comparable entry time, closure time, number of clips needed to close the incision, and gas-related events between longitudinal and transverse incisions.

REGISTRATION NUMBER

CTRI/2021/08/035829.

摘要

背景

经口内镜下肌切开术(POEM)治疗食管动力障碍时,黏膜下空间的入口通常采用纵行切口,另一种选择是横行切口,该入路的手术时间更短,发生与气体相关事件的几率更小。

方法

这是一项在三级护理医院进行的单中心、随机试验。患有食管动力障碍的患者被随机分为 A 组(纵行切口)和 B 组(横行切口)。主要目的是比较进入黏膜下空间所需的时间。次要目标是比较切口关闭所需的时间、关闭切口所需的夹数量以及与气体相关事件的发生情况。使用 Kelsey 方法计算了用于非劣效性设计的样本量。

结果

共随机分配 60 例患者(每组 30 例)。比较两种切口,进入时间[3(2,5)比 2(1.75,5)min,p=0.399]、关闭时间[7(4,13.5)比 9(6.75,19)min,p=0.155]和关闭切口所需的夹数量[4(4,6)比 5(4,7),p=0.156]无差异。此外,两组的气体相关事件发生率相似[气腹需要抽吸-5 例比 2 例,p=0.228,皮下气肿-3 例比 1 例,p=0.301]。

结论

这项随机试验表明,纵向切口和横向切口的进入时间、关闭时间、关闭切口所需的夹数量和与气体相关的事件相似。

注册号

CTRI/2021/08/035829。

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