title: Biologic vs synthetic inguinal hernia repair: 1-year results of a randomized double-blinded trial.
abstract: BACKGROUND
  Various surgical meshes are used in the repair of inguinal hernia and are associated with numerous complications. Our main objective in this study was to determine whether a biologic hernia matrix is equivalent to polypropylene mesh in an open inguinal hernia repair using the Lichtenstein technique.
  
  
  METHODS
  A prospective, randomized, double-blinded, single-center trial was conducted to evaluate the efficacy of a biologic Inguinal Hernia Matrix (IHM; Cook Medical) compared with polypropylene (PP) mesh using Lichtenstein's inguinal hernia repair in a 3-year outcomes study. Patients were evaluated for recurrence and complications by a blinded surgeon at 2 weeks, 3 months, 6 months, and 1 year post procedure. Patient demographics, including comorbidities and nutrition status, were recorded. Intraoperative information including hernia type and location, procedure time, level of difficulty, degree of surgeon frustration, and surgical experience were collected.
  
  
  RESULTS
  One hundred male patients provided informed consent and were randomized into the study in a 1:1 fashion. There were no significant differences in degree of difficulty and level of frustration between the 2 groups. At 1-year follow-up, 3 recurrences were diagnosed in the IHM group as compared with none in the PP group (p = 0.11). Persistent pain trended higher in the PP group (6% vs 4%). All 3 recurrences occurred in the direct inguinal hernia group and were performed by attendings in the first year post training (3 different attendings). No recurrences occurred in patients operated on by more senior surgeons.
  
  
  CONCLUSIONS
  The IHM hernioplasty compares favorably with PP mesh at 1-year follow-up with similar recurrence rates and complications. Surgeon experience appears to be a major factor affecting successful outcomes.
authors.affiliation: Department of Surgery, Section of Acute and Critical Care Surgery, Washington University in St Louis, St Louis, MO. Electronic address: bochicchiog@wustl.edu.
authors.forename: Grant V
authors.initials: GV
authors.lastname: Bochicchio
authors.affiliation: Baltimore VA Medical Center, Baltimore, MD.
authors.forename: Ajay
authors.initials: A
authors.lastname: Jain
authors.affiliation: Baltimore VA Medical Center, Baltimore, MD.
authors.forename: Kelly
authors.initials: K
authors.lastname: McGonigal
authors.affiliation: Baltimore VA Medical Center, Baltimore, MD.
authors.forename: Douglas
authors.initials: D
authors.lastname: Turner
authors.affiliation: Baltimore VA Medical Center, Baltimore, MD.
authors.forename: Obeid
authors.initials: O
authors.lastname: Ilahi
authors.affiliation: Department of Surgery, Section of Acute and Critical Care Surgery, Washington University in St Louis, St Louis, MO; Baltimore VA Medical Center, Baltimore, MD.
authors.forename: Stacey
authors.initials: S
authors.lastname: Reese
authors.affiliation: Department of Surgery, Section of Acute and Critical Care Surgery, Washington University in St Louis, St Louis, MO.
authors.forename: Kelly
authors.initials: K
authors.lastname: Bochicchio
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006552:Hernia, Inguinal / Q000601:surgery*; D059685:Herniorrhaphy / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D011126:Polypropylenes; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D012008:Recurrence; D013526:Surgical Mesh; D016896:Treatment Outcome
chemical_list: D011126:Polypropylenes