A Randomized, Blinded Trial Comparing Ovitex Mesh Versus Pledgeted Sutures for Paraesophageal Hernia Repair to Reduce Recurrence

What this Trial Is About

Researchers are evaluating whether using Ovitex mesh offers better reduction in paraesophageal hernia recurrence over two years compared to pledgeted suture closure for patients undergoing paraesophageal hernia repair. This randomized, double-blind trial enrolls adults with type II, III, or IV hiatal hernias larger than 5 cm. The study also aims to assess patient quality of life following the hernia repair using these two different reinforcement methods. Participants are randomly assigned to receive either Ovitex mesh or pledgeted sutures to reinforce the crural repair during surgery. The trial includes follow-up visits at about 1 month post-surgery and annually for two years, with additional long-term monitoring planned for up to seven years. The study uses blinded outcome assessors and surgeons to reduce bias, and the mesh used is FDA approved for this purpose. During the study, participants will undergo imaging tests like upper GI studies, CT, or MRI to check for hernia recurrence, with the main focus on recurrence rates two years after surgery. Researchers will also collect detailed quality of life data through several validated surveys at various times before and after surgery. Safety will be closely monitored by tracking intraoperative complications and other postoperative issues. Participants are expected to attend scheduled visits and complete questionnaires over the study period, which could total up to seven years including extended follow-up.

Mesh Vs Pledgets for Repair of Paraesophageal Hernia