title: The clinical effectiveness and cost-effectiveness of open mesh repairs in adults presenting with a clinically diagnosed primary unilateral inguinal hernia who are operated in an elective setting: systematic review and economic evaluation.
abstract: BACKGROUND
  Current open mesh techniques for inguinal hernia repair have shown similar recurrence rates. However, chronic pain has been associated with Lichtenstein mesh repair, the most common surgical procedure for inguinal hernia in the UK. The position of the mesh is probably an important factor. The Lichtenstein method requires dissection of the inguinal wall and fixation of the mesh. In contrast, in the open preperitoneal approach the mesh is placed in the preperitoneal space and held in place with intra-abdominal pressure. Currently, there is no consensus regarding the best open approach for repair of inguinal hernia.
  
  
  OBJECTIVE
  To determine the clinical effectiveness and cost-effectiveness of open preperitoneal mesh repair compared with Lichtenstein mesh repair in adults presenting with a clinically diagnosed primary unilateral inguinal hernia.
  
  
  METHODS
  We searched major electronic databases (e.g. MEDLINE, MEDLINE In-Process & Other Non-Indexed, EMBASE, Cochrane Controlled Trials Register) from inception to November 2014 and contacted experts in the field.
  
  
  METHODS
  Evidence was considered from randomised controlled trials (RCTs) that compared open preperitoneal mesh repair with Lichtenstein mesh repair for the treatment of inguinal hernia. Two reviewers independently selected studies for inclusion. One reviewer completed data extraction and assessed risk of bias for included studies, and two reviewers independently cross-checked the details extracted. Meta-analyses techniques were used to combine results from included studies. A Markov model was developed to assess the cost-effectiveness of open mesh procedures from a NHS health services perspective over a 25-year time horizon.
  
  
  RESULTS
  Twelve RCTs involving 1568 participants were included. Participants who underwent open preperitoneal mesh repair returned to work and normal activities significantly earlier than those who underwent Lichtenstein mesh repair [mean difference -1.49 days, 95% confidence interval (CI) -2.78 to -0.20 days]. Although no significant differences were observed between the two open approaches for incidence of pain [risk ratio (RR) 0.50, 95% CI 0.20 to 1.27], numbness (RR 0.48, 95% CI 0.15 to 1.56), recurrences (Peto odds ratio 0.76, 95% CI 0.38 to 1.52) or postoperative complications, fewer events were generally reported after open preperitoneal mesh repair. The results of the economic evaluation indicate that the open preperitoneal mesh repair was £256 less costly and improved health outcomes by 0.041 quality-adjusted life-years (QALYs) compared with Lichtenstein mesh repair. The open preperitoneal procedure was the most efficient and dominant treatment strategy with a high (> 98%) probability of being cost-effectiveness for the NHS at a willingness to pay of £20,000 for a QALY. Results were robust to a range of sensitivity analyses. However, the magnitude of cost saving or QALY gain was sensitive to some model assumptions.
  
  
  CONCLUSIONS
  Overall, the included trials were of small sample size (mean 130.7 participants) and at high or unclear risk of bias. Meta-analyses results demonstrated significant statistical heterogeneity for most of the assessed outcomes.
  
  
  CONCLUSIONS
  Open preperitoneal mesh repair appears to be a safe and efficacious alternative to Lichtenstein mesh repair. Further research is required to determine the long-term effects of these surgical procedures as well as the most effective open preperitoneal repair technique in terms of both clinical efficacy and costs.
  
  
  BACKGROUND
  This study is registered as PROSPERO CRD42014013510.
  
  
  BACKGROUND
  The National Institute for Health Research Health Technology Assessment programme.
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Pawana
authors.initials: P
authors.lastname: Sharma
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.|Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Dwayne
authors.initials: D
authors.lastname: Boyers
authors.affiliation: Medical Statistics Team, University of Aberdeen, Aberdeen, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Scott
authors.affiliation: Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Hernández
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Fraser
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Moira
authors.initials: M
authors.lastname: Cruickshank
authors.affiliation: NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, UK.
authors.forename: Irfan
authors.initials: I
authors.lastname: Ahmed
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Craig
authors.initials: C
authors.lastname: Ramsay
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Miriam
authors.initials: M
authors.lastname: Brazzelli
mesh_terms: D000328:Adult; D003362:Cost-Benefit Analysis; D017558:Elective Surgical Procedures / Q000191:economics*; D004867:Equipment Design; D006552:Hernia, Inguinal / Q000601:surgery*; D006801:Humans; D011183:Postoperative Complications / Q000191:economics; D012008:Recurrence; D013526:Surgical Mesh; D013673:Technology Assessment, Biomedical / Q000191:economics; D016896:Treatment Outcome