背景:接受食管旁疝修补术(PEHR)的患者中,有一半以上的患者在手术后5年内会出现影像学上的疝复发。胃切除术是一种相对低风险的干预措施,可以降低复发率。但尚未进行前瞻性研究。我们的研究旨在评估前胃切除术对PEHR术后复发率的影响。与没有前胃切除术相比。
方法:这是一个双臂,单盲,基于注册表,在PEHR中比较前胃切除术和非前胃切除术的随机对照试验。有症状的食管旁疝的成人患者(≥18岁),计算机断层扫描高度至少为5cm,上消化道系列,或接受选择性微创修复的内窥镜检查符合招募条件。患者将对试验的手臂视而不见。所有患者将接受腹腔镜或机器人PEHR,其中一些手术技术(腿部闭合技术和胃底折叠术的使用或避免)由手术外科医生自行决定。在操作过程中,在diaphragm肌闭合后,参与者被随机分为不接受前胃切除术(对照组)或接受前胃切除术(治疗组).将招募240名参与者,并在手术后随访1年。主要结果是1年时影像学PEH复发。次要结果是胃食管反流病的症状,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,术后即刻和1年随访时的肺部症状以及患者满意度。结果评估员将对患者的干预措施视而不见。
结论:这项随机对照试验将研究前胃切除术对影像学PEH复发和患者报告结局的影响。前胃切除术具有减少PEH复发的理论益处;然而,除了回顾性系列的有效性建议外,这还没有得到证实。如果前胃切除术降低复发率,它可能成为PEH外科管理的常规组成部分.如果它不能减少PEH复发,它很可能会被抛弃。
背景:ClinicalTrials.govNCT04007952。2019年7月5日注册。
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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT04007952 . Registered on July 5, 2019.