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).
CONCLUSIONS: 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.
BACKGROUND: CTRI/2021/08/035829.
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).
CONCLUSIONS: 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.
BACKGROUND: CTRI/2021/08/035829.
摘要：
背景：纵向切口是经口内镜下肌切开术（POEM）治疗食管运动性疾病时进入粘膜下间隙的常用切口。横向切口是另一种可供选择的方法，回顾性数据表明它的手术时间和发生气体相关事件的机会更少。
方法：这是一个单中心，在三级保健医院进行的随机试验.将接受POEM治疗的食管运动障碍患者随机分为A组（纵向切口）和B组（横向切口）。主要目的是比较进入粘膜下空间所需的时间。次要目标是比较闭合切口所需的时间，闭合切口所需的夹子数量，以及与天然气有关的事件的发展。使用Kelsey方法计算非劣效性设计的样本量。
结果：60例患者随机分组（每组30例）。在比较两种类型的切口时，进入时间[3（2，5）对2（1.75，5）分钟没有差异，p=0.399],闭合时间[7（4，13.5）对9（6.75，19）分钟，p=0.155],和闭合所需的夹子数量[4(4,6)和5(4,7),p=0.156]。此外,两组间与气体相关的事件具有可比性(腹膜需抽吸-5vs2,p=0.228,皮下气肿-3vs1,p=0.301).
结论：这项随机试验显示了相当的进入时间，关闭时间,闭合切口所需的夹子数量，以及纵向和横向切口之间与气体相关的事件。
背景：CTRI/2021/08/035829。
方法：这是一个单中心，在三级保健医院进行的随机试验.将接受POEM治疗的食管运动障碍患者随机分为A组（纵向切口）和B组（横向切口）。主要目的是比较进入粘膜下空间所需的时间。次要目标是比较闭合切口所需的时间，闭合切口所需的夹子数量，以及与天然气有关的事件的发展。使用Kelsey方法计算非劣效性设计的样本量。
结果：60例患者随机分组（每组30例）。在比较两种类型的切口时，进入时间[3（2，5）对2（1.75，5）分钟没有差异，p=0.399],闭合时间[7（4，13.5）对9（6.75，19）分钟，p=0.155],和闭合所需的夹子数量[4(4,6)和5(4,7),p=0.156]。此外,两组间与气体相关的事件具有可比性(腹膜需抽吸-5vs2,p=0.228,皮下气肿-3vs1,p=0.301).
结论：这项随机试验显示了相当的进入时间，关闭时间,闭合切口所需的夹子数量，以及纵向和横向切口之间与气体相关的事件。
背景：CTRI/2021/08/035829。
