Comparing anterior gastropexy to no anterior gastropexy for paraesophageal hernia repair: a study protocol for a randomized control trial

Abstract

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.