title: Long-term follow-up of a randomized controlled trial of Lichtenstein's operation versus mesh plug repair for inguinal hernia.
abstract: OBJECTIVE
  To compare long-term results of Lichtenstein's operation versus mesh plug repair for open inguinal hernia repair.
  
  
  BACKGROUND
  The technique of best choice in open prosthetic inguinal hernia repair remains a subject of ongoing debate.
  
  
  METHODS
  In this prospective, randomized controlled multicenter trial, patients with primary or recurrent inguinal hernias were randomized to undergo either Lichtenstein's operation or mesh plug repair. The primary endpoint was the long-term recurrence rate. Secondary endpoints included chronic pain, sensibility disorders, and reoperation rate.
  
  
  RESULTS
  In total, 697 hernias in 594 patients were randomized (297 patients per group). At a median follow-up of 6.5 years, 528 (76%) operated hernias in 444 (75%) patients were clinically evaluated. The recurrence rate was similar in both groups [mesh plug: 21/268 hernias = 7.8%; Lichtenstein: 21/260 hernias = 8.1%; adjusted odds ratio (OR): 0.92; 95% confidence interval (CI): 0.51, 1.68; P = 0.795]. We did not find a significant difference for chronic pain (Visual Analog Scale score >3) (OR: 0.58; 95% CI: 0.31, 1.09; P = 0.088) and sensory testing (17% vs 20% of patients; OR: 0.53; 95% CI: 0.21, 1.37; P = 0.190) between the 2 groups. There were less reoperations in the mesh plug than in the Lichtenstein's operation group (OR: 0.43; 95% CI: 0.22, 0.85; P = 0.016).
  
  
  CONCLUSIONS
  The long-term results of this trial indicate not enough evidence for differences in recurrence, chronic pain, and sensibility disorders between mesh plug repair and Lichtenstein's operation but a lower likelihood for reoperation for mesh plug repair. Estimates for all endpoints were statistically not significant or based on large CIs.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01637818.
authors.affiliation: *Division of General and Visceral Surgery and †Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland ‡Division of Visceral Surgery and Medicine, University Hospital Bern, Bern, Switzerland §Division of Visceral Surgery, Cantonal Hospital Olten, Olten, Switzerland ¶Division of Visceral Surgery, Cantonal Hospital Lucerne, Lucerne, Switzerland ‖Division of Visceral Surgery, Kreiskrankenhaus Lörrach, Lörrach, Germany **Division of General Surgery, Gesundheitszentrum Wetzikon, Wetzikon, Switzerland.
authors.forename: Raoul A
authors.initials: RA
authors.lastname: Droeser
authors.forename: Salome
authors.initials: S
authors.lastname: Dell-Kuster
authors.forename: Anita
authors.initials: A
authors.lastname: Kurmann
authors.forename: Rachel
authors.initials: R
authors.lastname: Rosenthal
authors.forename: Markus
authors.initials: M
authors.lastname: Zuber
authors.forename: Jürg
authors.initials: J
authors.lastname: Metzger
authors.forename: Daniel
authors.initials: D
authors.lastname: Oertli
authors.forename: Christian T
authors.initials: CT
authors.lastname: Hamel
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Frey
mesh_terms: D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006552:Hernia, Inguinal / Q000601:surgery*; D059685:Herniorrhaphy / Q000379:methods*; D015994:Incidence; D011183:Postoperative Complications / Q000453:epidemiology*; D011446:Prospective Studies; D012008:Recurrence; D013526:Surgical Mesh; D013557:Switzerland / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome