Abstract
BACKGROUND: Laparoscopic repair is the standard treatment for symptomatic paraesophageal and mixed hiatal hernias; however, recurrence rates remain high, particularly in large defects. Mesh reinforcement has been used to improve outcomes, but the optimal mesh type remains debated. OviTex 1S, a reinforced tissue matrix composed of ovine extracellular matrix and polypropylene, has demonstrated safety in abdominal wall reconstruction, though data for hiatal hernia repair are limited. METHODS: We conducted a prospective, single-arm, single-institution study evaluating laparoscopic hiatal hernia repair with OviTex 1S mesh between January 2020 and February 2024. Adults with radiologic or endoscopic confirmation of hiatal hernia requiring mesh reinforcement were included. Primary endpoints were hernia recurrence and reflux symptom improvement. Secondary endpoints included quality of life, assessed using reflux severity scores and the Gastroesophageal Reflux Disease (GERD)-Health-Related Quality of Life (HRQL) survey. Patients were followed at 1, 3, 6, 12, and 24 months. RESULTS: Of 443 patients undergoing paraesophageal hernia repair, 108 received OviTex 1S reinforcement. Mean age was 65.5 years, mean body mass index (BMI) 28.1 kg/m², and 82.2% were female. Three perioperative recurrences (2.8%) required reoperation. Overall recurrence occurred in 21 patients (19.4%), most beyond six months. GERD-HRQL scores improved by more than 50% at 12 months (20 ± 4.75 vs 4 ± 7; P = .02). Proton pump inhibitor use declined from 91.6% preoperatively to 9.4% postoperatively. No mesh-related erosions or strictures were observed. CONCLUSIONS: OviTex 1S mesh reinforcement during laparoscopic hiatal hernia repair is safe, improves reflux-related quality of life, and demonstrates low early recurrence. Long-term benefits remain limited, warranting larger multicenter studies.