A multi-center, prospective clinical trial of a hepatic derived porcine surgical mesh for the laparoscopic repair of symptomatic paraesophageal hernias. Am J Surg 2019 Aug;218(2):315-322
Date
04/08/2019Pubmed ID
30954232DOI
10.1016/j.amjsurg.2019.03.025Scopus ID
2-s2.0-85063745593 (requires institutional sign-in at Scopus site) 9 CitationsAbstract
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.
Author List
Rosen MJ, Borao FJ, Binenbaum SJ, Roth JS, Gillian GK, Gould J, Heniford BTAuthor
Jon Gould MD Chief, Professor in the Surgery department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdultAged
Animals
Bioprosthesis
Female
Hernia, Hiatal
Herniorrhaphy
Humans
Laparoscopy
Liver
Male
Middle Aged
Prospective Studies
Prosthesis Design
Surgical Mesh
Swine
