PDF(Pubmed)
Abstract：
UNASSIGNED: Surgical repair of paraesophageal hernias (PEHs) is burdened with high recurrence rates, and hitherto various techniques explored to enforce the traditional crural repair have not been successful. The hiatal reconstruction in PEH is exposed to significant tension, which may be minimized by adding a diaphragmatic relaxing incision to enhance the durability of the crural repair.
UNASSIGNED: All individuals undergoing elective laparoscopic repair of a large PEH, irrespective of age, were considered eligible. PEHs were classified into types II-IV. The preoperative work-up program included multidetector computed tomography and symptom assessment questionnaires, which will be repeated during the postoperative follow-up. Patients were randomly divided into a control group with crural repair alone and an intervention group with the addition of a left-sided diaphragmatic relaxing incision at the edge of the upper pole of the spleen. The diaphragmatic defect was then covered by a synthetic mesh.
UNASSIGNED: The primary endpoint of this trial was the rate of anatomical PEH recurrence at 1 year. Secondary endpoints included symptomatic gastroesophageal reflux disease, dysphagia, odynophagia, gas bloat, regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular and pulmonary symptoms, and patient satisfaction in the immediate postoperative course (3 months) and at 1 year. Postoperative complications, morbidity, and disease burden were recorded for each patient. This was a double-blind study, meaning that the operation report was filed in a locked archive to keep the patient, staff, and clinical assessors blinded to the study group allocation. Blinding must not be broken during the follow-up unless required by any emergencies in the clinical management of the patient. Likewise, the patients must not be informed about the details of the operation.
UNASSIGNED: ClinicalTrials.gov, identification number NCT04179578.
UNASSIGNED: All individuals undergoing elective laparoscopic repair of a large PEH, irrespective of age, were considered eligible. PEHs were classified into types II-IV. The preoperative work-up program included multidetector computed tomography and symptom assessment questionnaires, which will be repeated during the postoperative follow-up. Patients were randomly divided into a control group with crural repair alone and an intervention group with the addition of a left-sided diaphragmatic relaxing incision at the edge of the upper pole of the spleen. The diaphragmatic defect was then covered by a synthetic mesh.
UNASSIGNED: The primary endpoint of this trial was the rate of anatomical PEH recurrence at 1 year. Secondary endpoints included symptomatic gastroesophageal reflux disease, dysphagia, odynophagia, gas bloat, regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular and pulmonary symptoms, and patient satisfaction in the immediate postoperative course (3 months) and at 1 year. Postoperative complications, morbidity, and disease burden were recorded for each patient. This was a double-blind study, meaning that the operation report was filed in a locked archive to keep the patient, staff, and clinical assessors blinded to the study group allocation. Blinding must not be broken during the follow-up unless required by any emergencies in the clinical management of the patient. Likewise, the patients must not be informed about the details of the operation.
UNASSIGNED: ClinicalTrials.gov, identification number NCT04179578.
摘要：
■食管旁疝（PEHs）的手术修复负担较高的复发率，迄今为止，为实施传统的脚部修复而探索的各种技术都没有成功。PEH的食管重建暴露于显著的张力,这可以通过增加膈肌松弛切口来最小化，以增强腿部修复的耐久性。
■所有接受大型PEH选择性腹腔镜修复的患者，不论年龄,被认为是合格的。PEHs分为II-IV型。术前检查方案包括多探测器计算机断层扫描和症状评估问卷，这将在术后随访期间重复。将患者随机分为对照组和干预组，对照组仅进行小腿修复，干预组在脾脏上极边缘增加左侧膈肌松弛切口。然后用合成网覆盖膈缺损。
■本试验的主要终点是1年时PEH的解剖学复发率。次要终点包括症状性胃食管反流病，吞咽困难,吞咽困难,气体膨胀，返流,胸痛,腹痛,恶心,呕吐,餐后疼痛,心血管和肺部症状，术后即刻（3个月）和1年的患者满意度。术后并发症,发病率，并记录每位患者的疾病负担.这是一项双盲研究,这意味着手术报告被归档在一个锁定的档案中以保存病人，工作人员,和临床评估人员对研究组的分配不了解。除非患者临床管理中的任何紧急情况需要，否则在随访期间不得中断失明。同样，患者不得被告知手术细节。
■ClinicalTrials.gov,标识号NCT04179578。
■所有接受大型PEH选择性腹腔镜修复的患者，不论年龄,被认为是合格的。PEHs分为II-IV型。术前检查方案包括多探测器计算机断层扫描和症状评估问卷，这将在术后随访期间重复。将患者随机分为对照组和干预组，对照组仅进行小腿修复，干预组在脾脏上极边缘增加左侧膈肌松弛切口。然后用合成网覆盖膈缺损。
■本试验的主要终点是1年时PEH的解剖学复发率。次要终点包括症状性胃食管反流病，吞咽困难,吞咽困难,气体膨胀，返流,胸痛,腹痛,恶心,呕吐,餐后疼痛,心血管和肺部症状，术后即刻（3个月）和1年的患者满意度。术后并发症,发病率，并记录每位患者的疾病负担.这是一项双盲研究,这意味着手术报告被归档在一个锁定的档案中以保存病人，工作人员,和临床评估人员对研究组的分配不了解。除非患者临床管理中的任何紧急情况需要，否则在随访期间不得中断失明。同样，患者不得被告知手术细节。
■ClinicalTrials.gov,标识号NCT04179578。
