title: Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial.
abstract: BACKGROUND
  In 2006, we reported results of a randomized trial of laparoscopic paraesophageal hernia repair (LPEHR), comparing primary diaphragm repair (PR) with primary repair buttressed with a biologic prosthesis (small intestinal submucosa [SIS]). The primary endpoint, radiologic hiatal hernia (HH) recurrence, was higher with PR (24%) than with SIS buttressed repair (9%) after 6 months. The second phase of this trial was designed to determine the long-term durability of biologic mesh-buttressed repair.
  
  
  METHODS
  We systematically searched for the 108 patients in phase I of this study to assess current clinical symptoms, quality of life (QOL) and determine ongoing durability of the repair by obtaining a follow-up upper gastrointestinal series (UGI) read by 2 radiologists blinded to treatment received. HH recurrence was defined as the greatest measured vertical height of stomach being at least 2 cm above the diaphragm.
  
  
  RESULTS
  At median follow-up of 58 months (range 42 to 78 mo), 10 patients had died, 26 patients were not found, 72 completed clinical follow-up (PR, n = 39; SIS, n = 33), and 60 repeated a UGI (PR, n = 34; SIS, n = 26). There were 20 patients (59%) with recurrent HH in the PR group and 14 patients (54%) with recurrent HH in the SIS group (p = 0.7). There was no statistically significant difference in relevant symptoms or QOL between patients undergoing PR and SIS buttressed repair. There were no strictures, erosions, dysphagia, or other complications related to the use of SIS mesh.
  
  
  CONCLUSIONS
  LPEHR results in long and durable relief of symptoms and improvement in QOL with PR or SIS. There does not appear to be a higher rate of complications or side effects with biologic mesh, but its benefit in reducing HH recurrence diminishes at long-term follow-up (more than 5 years postoperatively) or earlier.
authors.affiliation: Department of Surgery, University of Washington, Seattle, WA 98195-6410, USA. brant@uw.edu
authors.forename: Brant K
authors.initials: BK
authors.lastname: Oelschlager
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Pellegrini
authors.forename: John G
authors.initials: JG
authors.lastname: Hunter
authors.forename: Michael L
authors.initials: ML
authors.lastname: Brunt
authors.forename: Nathaniel J
authors.initials: NJ
authors.lastname: Soper
authors.forename: Brett C
authors.initials: BC
authors.lastname: Sheppard
authors.forename: Nayak L
authors.initials: NL
authors.lastname: Polissar
authors.forename: Moni B
authors.initials: MB
authors.lastname: Neradilek
authors.forename: Lee M
authors.initials: LM
authors.lastname: Mitsumori
authors.forename: Charles A
authors.initials: CA
authors.lastname: Rohrmann
authors.forename: Lee L
authors.initials: LL
authors.lastname: Swanstrom
mesh_terms: D001705:Bioprosthesis; D005260:Female; D005500:Follow-Up Studies; D006551:Hernia, Hiatal / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011859:Radiography; D055502:Secondary Prevention