A multi-center, prospective clinical trial of a hepatic derived porcine surgical mesh for the laparoscopic repair of symptomatic paraesophageal hernias.

INTRODUCTION

We report the results of a multicenter trial evaluating a unique, biological mesh (MIROMESH) derived from decellularized porcine liver for hiatal cruralplasty during laparoscopic PEHR.

METHODS

41 subjects underwent a laparoscopic PEHR which included primary crural closure, and MIROMESH onlay. Subjects were assessed at 2-weeks and 6, 12, 18 and 24 months using the SF-36, GERD-HRQL questionnaire, and VAS GERD related symptoms, and UGI.

RESULTS

Mean procedure time was 143.0 (±45.2) minutes, 93% had a Type III hiatal hernia and median LOS was 3 days. Of 27 patients available for 2 years follow up, no patients required surgical reintervention for symptomatic hernia recurrence or adverse events. Radiographic follow up revealed a 10% hiatal hernia recurrence rate. GERD HRQL scores were significantly improved from baseline to two years follow up. All the GERD symptoms measured showed significant and sustained improvement at all post-operative time periods.

CONCLUSION

The utilization of MIROMESH for crural reinforcement during laparoscopic PEHR resulted in excellent symptomatic improvement in our multicenter trial with a 10% 2 year radiographic recurrence rate.