Abstract
INTRODUCTION: Laparoscopic hiatal hernia (HH) repair is associated with a high recurrence rate. Repair reinforced with mesh lowers short-term recurrence but can cause dysphagia and visceral erosion. Results of the PRIME trial, in which non-absorbable mesh reinforcement of the posterior crural repair was investigated, showed equal recurrence compared with primary suture repair after 6 months. This study investigates the use of circular absorbable mesh reinforcement in primary HH repair. METHODS AND ANALYSIS: Prospective double-blinded randomised controlled superiority trial comparing two laparoscopic procedures for HH repair (110 vs 110). Adult patients with proven HH Skinner types II-IV (defined by preoperative CT scan) are included. Patients are randomised to undergo a laparoscopic primary crural repair with sutures alone or suture repair augmented with biosynthetic absorbable, circular mesh at the hiatus. Radiologic integrity of the hiatal repair 1 year after surgery is the main endpoint. Secondary objectives are clinical recurrence of the hernia, development of postoperative reflux disease, postoperative side effects and satisfaction with surgical outcome. Outcome assessors are blinded to allocation. Data are collected at baseline, and follow-up includes interviews and digital questionnaires at 3, 12, 24, 36, 48 and 60 months, as well as CT scan at 12 and 60 months. All patients randomised will be analysed according to the intention-to-treat principle. ETHICS AND DISSEMINATION: Ethics approval has been obtained by the local ethics committee at Isala, Zwolle, the Netherlands (Medical Ethics Review Committee (METc) Isala, study number: 190516). METc Isala is no longer active; all duties have been taken over by METc of the University Medical Center Groningen. The trial's results will be submitted to a peer-reviewed international journal as well as (inter)national conferences. TRIAL REGISTRATION NUMBER: Registered in the Dutch national trial registry: OMON (NL-OMON48062).