Randomized clinical trial comparing laparoscopic hiatal hernia repair using sutures versus sutures reinforced with non-absorbable mesh

Background Current literature is characterized by a discrepancy between reported symptomatic and radiological recurrent hiatal hernia’s following primary repair. Crural augmentation using mesh is suggested to reduce recurrence rates. The aim of this trial is to analyze 1-year outcome of laparoscopic hiatal hernia repair using sutures versus sutures reinforced with non-absorbable mesh. Methods Between 2013 and 2016, 72 patients with an objectified hiatal hernia were randomized for primary repair using non-absorbable sutures and sutures reinforced with non-absorbable mesh. Data regarding the incidence of recurrent hiatal hernia, need for endoscopic dilatation or surgical reintervention, postoperative dysphagia and/or reflux symptoms, general health, and use of acid-suppressing medication were analyzed. Results 72 patients ( n = 36 vs. n = 36) were included. One year after primary repair and repair using non-absorbable mesh, there were no differences in the number of recurrent hiatal hernia’s demonstrated by barium swallow radiology ( n = 4 [11.4%] vs. n = 6 [19.4%], p = 0.370) or upper gastrointestinal endoscopy ( n = 5 [14.4%] vs. n = 5 [17.2%], p = 0.746), the number of surgical reinterventions ( n = 2 [5.6%] vs. n = 1 [2.8%], p = 1.000), nor in chest pain and heartburn scores, with comparable dysphagia and satisfaction scores. Compared to the preoperative state, both groups demonstrated a comparable and significant reduction in chest pain score and Dakkak dysphagia score. Conclusions Use of non-absorbable mesh to reinforce primary hiatal hernia repair results in equal hiatal hernia recurrence and symptomatic outcome compared to repair using sutures alone. During 1-year follow-up, there were no mesh-related complications. Follow-up beyond 1 year needs to demonstrate whether these findings are sustained.