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.
['Rosen|Michael J|MJ|', 'Borao|Frank J|FJ|', 'Binenbaum|Steven J|SJ|', 'Roth|J Scott|JS|', 'Gillian|G Kevin|GK|', 'Gould|Jon|J|', 'Heniford|B Todd|BT|']
D000328:Adult D000368:Aged D000818:Animals D001705:Bioprosthesis D005260:Female D006551:Hernia, Hiatal D059685:Herniorrhaphy D006801:Humans D010535:Laparoscopy D008099:Liver D008297:Male D008875:Middle Aged D011446:Prospective Studies D011474:Prosthesis Design D013526:Surgical Mesh D013552:Swine
Biologic mesh Hiatal hernia recurrence And quality of life Laparoscopic paraesophageal hernia repair Long term outcomes Prospective study