比较胃前固定术与非胃前固定术治疗食管裂孔疝修补术的效果：一项随机对照试验的研究方案。
Comparing anterior gastropexy to no anterior gastropexy for paraesophageal hernia repair: a study protocol for a randomized control trial.
机构信息
Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA.
Department of Quantitative Health Sciences, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
出版信息
Trials. 2022 Jul 30;23(1):616. doi: 10.1186/s13063-022-06571-8.
BACKGROUND
More than half of patients undergoing paraesophageal hernia repair (PEHR) will have radiographic hernia recurrence at 5 years after surgery. Gastropexy is a relatively low-risk intervention that may decrease recurrence rates, but it has not been studied in a prospective manner. Our study aims to evaluate the effect of anterior gastropexy on recurrence rates after PEHR, compared to no anterior gastropexy.
METHODS
This is a two-armed, single-blinded, registry-based, randomized controlled trial comparing anterior gastropexy to no anterior gastropexy in PEHR. Adult patients (≥18 years) with a symptomatic paraesophageal hernia measuring at least 5 cm in height on computed tomography, upper gastrointestinal series, or endoscopy undergoing elective minimally invasive repair are eligible for recruitment. Patients will be blinded to their arm of the trial. All patients will undergo laparoscopic or robotic PEHR, where some operative techniques (crural closure techniques and fundoplication use or avoidance) are left to the discretion of the operating surgeon. During the operation, after closure of the diaphragmatic crura, participants are randomized to receive either no anterior gastropexy (control arm) or anterior gastropexy (treatment arm). Two hundred forty participants will be recruited and followed for 1 year after surgery. The primary outcome is radiographic PEH recurrence at 1 year. Secondary outcomes are symptoms of gastroesophageal reflux disease, dysphagia, odynophagia, gas bloat, regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms as well as patient satisfaction in the immediate postoperative period and at 1-year follow-up. Outcome assessors will be blinded to the patients' intervention.
DISCUSSION
This randomized controlled trial will examine the effect of anterior gastropexy on radiographic PEH recurrence and patient-reported outcomes. Anterior gastropexy has a theoretical benefit of decreasing PEH recurrence; however, this has not been proven beyond a suggestion of effectiveness in retrospective series. If anterior gastropexy reduces recurrence rates, it would likely become a routine component of surgical PEH management. If it does not reduce PEH recurrence, it will likely be abandoned.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04007952 . Registered on July 5, 2019.
背景
超过一半接受食管裂孔疝修补术（PEHR）的患者在手术后 5 年内会出现放射影像学疝复发。胃固定术是一种相对低风险的干预措施，可能会降低复发率，但尚未以前瞻性方式进行研究。我们的研究旨在评估与无前胃固定术相比，PEHR 中前胃固定术对复发率的影响。
方法
这是一项双臂、单盲、基于登记的、随机对照临床试验，比较了前胃固定术与 PEHR 中的无前胃固定术。有症状的食管裂孔疝患者（≥ 18 岁），CT、上消化道系列或内镜检查显示高度至少 5cm，适合接受择期微创修复，有资格入组。患者将对试验的分组保持盲态。所有患者均接受腹腔镜或机器人 PEHR，其中一些手术技术（横膈脚闭合技术和使用或避免胃底折叠术）由手术医生决定。在手术过程中，在横膈脚关闭后，参与者被随机分配接受前胃固定术（治疗组）或无前胃固定术（对照组）。将招募 240 名参与者，并在手术后 1 年进行随访。主要结局是术后 1 年放射影像学食管裂孔疝复发。次要结局是胃食管反流病、吞咽困难、咽痛、气胀、反流、胸痛、腹痛、恶心、呕吐、餐后疼痛、心血管和肺部症状以及患者在术后即刻和 1 年随访时的满意度。结果评估者将对患者的干预措施保持盲态。
讨论
这项随机对照试验将研究前胃固定术对放射影像学食管裂孔疝复发和患者报告结局的影响。前胃固定术具有降低食管裂孔疝复发的理论益处；然而，这尚未在回顾性系列研究之外得到证实。如果前胃固定术降低复发率，它可能成为手术食管裂孔疝管理的常规组成部分。如果它不能降低食管裂孔疝复发率，它可能会被放弃。
试验注册
ClinicalTrials.gov NCT04007952。于 2019 年 7 月 5 日注册。
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