Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only for Large Hiatal Hernia Primary Treatment in a Multicenter Randomized Phase III Trial

What this Trial Is About

Large hiatal hernia (LHH) affects about half of laparoscopic antireflux surgeries and often recurs after repair, with up to 30% recurrence reported within two years. Researchers are studying whether adding a biosynthetic absorbable mesh to the standard suture repair reduces the chance of hernia coming back, without increasing complications. This phase III trial compares mesh reinforcement to no mesh in patients with symptomatic LHH to better understand which approach offers improved outcomes. Participants will undergo laparoscopic hiatal hernia repair either with or without the use of a biosynthetic absorbable mesh patch. This randomized, parallel-group study evaluates two groups: one receiving mesh reinforcement and the other receiving standard suture repair alone. The trial lasts at least two years, focusing on the rate of hernia recurrence and other health outcomes following surgery. During the study, participants will have regular assessments including imaging to detect hernia recurrence at 24 months. Quality of life will be measured using questionnaires (GIQLI, SF36, EQ-5D-5L, EQ-VAS) at multiple time points from the day of surgery through two years. Researchers will also monitor complications, fever, weight, and blood pressure to track safety and overall health. This comprehensive follow-up aims to evaluate both the effectiveness and cost-effectiveness of mesh use in LHH repair.

Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia