Comparison of short-term clinical efficacy and safety between biological and synthetic meshes in laparoscopic hiatal hernia repair: a single-center randomized controlled trial.

Abstract

<h4>Background</h4>The optimal choice of mesh material in laparoscopic hiatal hernia repair (LHHR) is debated. This study aimed to compare the short-term clinical efficacy and safety of biological versus synthetic meshes in LHHR.<h4>Methods</h4>In a prospective, single-center randomized controlled trial conducted from January 2020 to December 2022, 124 patients undergoing LHHR were enrolled and randomly assigned to either the biological mesh group (n = 62) or the synthetic mesh group (n = 62). The biological mesh group received non-crosslinked biological mesh, while the synthetic mesh group received polypropylene anti-adhesion mesh for hiatal closure reinforcement. Randomization was computer-generated. Baseline characteristics were collected, and patients were followed up at 6, 12, and 18 months postoperatively through telephone interviews or outpatient visits. The primary outcome was the recurrence rate of hiatal hernia, assessed by gastroscopy and upper gastrointestinal contrast radiography. Secondary outcomes included symptom improvement evaluated using the Visual Analog Scale (VAS) and the Short Form-36 (SF-36) Health Survey Questionnaire, as well as quality of life improvements. The safety of mesh was assessed by recording mesh-related complications.<h4>Results</h4>Baseline characteristics were comparable between the two groups. At 18 months, the recurrence rate was 1.92% in the synthetic mesh group and 9.26% in the biological mesh group (P = 0.225). At 6 months, the biological mesh group reported significantly less early satiety compared to the synthetic mesh group (0.35 ± 1.09 vs. 0.95 ± 1.99; P = 0.046). Conversely, at 18 months, early satiety was lower in the synthetic mesh group compared to the biological mesh group (0.31 ± 1.35 vs. 1.04 ± 2.21; P = 0.043). No significant differences were observed between the groups for other symptoms or SF-36 domains at any time point (all P > 0.05). Both groups showed significant improvements in some symptoms and quality of life from preoperative to postoperative assessments (P < 0.05). No mesh-related complications were reported in either group throughout the 18-month follow-up period.<h4>Conclusions</h4>Both biological and synthetic meshes are effective and safe for use in LHHR, demonstrating similar recurrence rates and improvements in symptoms and quality of life over an 18-month period. The choice of mesh may influence early satiety at different postoperative intervals, suggesting that individualized mesh selection based on patient-specific factors may enhance postoperative outcomes.