title: Biologic prosthesis reduces recurrence after laparoscopic paraesophageal hernia repair: a multicenter, prospective, randomized trial.
abstract: OBJECTIVE
  Laparoscopic paraesophageal hernia repair (LPEHR) is associated with a high recurrence rate. Repair with synthetic mesh lowers recurrence but can cause dysphagia and visceral erosions. This trial was designed to study the value of a biologic prosthesis, small intestinal submucosa (SIS), in LPEHR.
  
  
  METHODS
  Patients undergoing LPEHR (n = 108) at 4 institutions were randomized to primary repair -1 degrees (n = 57) or primary repair buttressed with SIS (n = 51) using a standardized technique. The primary outcome measure was evidence of recurrent hernia (> or =2 cm) on UGI, read by a study radiologist blinded to the randomization status, 6 months after operation.
  
  
  RESULTS
  At 6 months, 99 (93%) patients completed clinical symptomatic follow-up and 95 (90%) patients had an UGI. The groups had similar clinical presentations (symptom profile, quality of life, type and size of hernia, esophageal length, and BMI). Operative times (SIS 202 minutes vs. 1 degrees 183 minutes, P = 0.15) and perioperative complications did not differ. There were no operations for recurrent hernia nor mesh-related complications. At 6 months, 4 patients (9%) developed a recurrent hernia >2 cm in the SIS group and 12 patients (24%) in the 1 degrees group (P = 0.04). Both groups experienced a significant reduction in all measured symptoms (heartburn, regurgitation, dysphagia, chest pain, early satiety, and postprandial pain) and improved QOL (SF-36) after operation. There was no difference between groups in either pre or postoperative symptom severity. Patients with a recurrent hernia had more chest pain (2.7 vs. 1.0, P = 0.03) and early satiety (2.8 vs. 1.3, P = 0.02) and worse physical functioning (63 vs. 72, P = 0.03 per SF-36).
  
  
  CONCLUSIONS
  Adding a biologic prosthesis during LPEHR reduces the likelihood of recurrence at 6 months, without mesh-related complications or side effects.
authors.affiliation: University of Washington, Seattle, WA, USA. brant@u.washington.edu
authors.forename: Brant K
authors.initials: BK
authors.lastname: Oelschlager
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Pellegrini
authors.forename: John
authors.initials: J
authors.lastname: Hunter
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Soper
authors.forename: Michael
authors.initials: M
authors.lastname: Brunt
authors.forename: Brett
authors.initials: B
authors.lastname: Sheppard
authors.forename: Blair
authors.initials: B
authors.lastname: Jobe
authors.forename: Nayak
authors.initials: N
authors.lastname: Polissar
authors.forename: Lee
authors.initials: L
authors.lastname: Mitsumori
authors.forename: James
authors.initials: J
authors.lastname: Nelson
authors.forename: L
authors.initials: L
authors.lastname: Swanstrom
mesh_terms: D000368:Aged; D001705:Bioprosthesis; D005260:Female; D006551:Hernia, Hiatal / Q000517:prevention & control* / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence