title: Watchful Waiting Versus Surgery of Mildly Symptomatic or Asymptomatic Inguinal Hernia in Men Aged 50 Years and Older: A Randomized Controlled Trial.
abstract: OBJECTIVE
  To compare if watchful waiting is noninferior to elective repair in men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia.
  
  
  BACKGROUND
  The role of watchful waiting in older male patients with mildly symptomatic or asymptomatic inguinal hernia is still not well-established.
  
  
  METHODS
  In this noninferiority trial, we randomly assigned men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia to either elective inguinal hernia repair or watchful waiting. Primary endpoint was the mean difference in a 4-point pain/discomfort score at 24 months of follow-up. Using a 0.20-point difference as a clinically relevant margin, it was hypothesized that watchful waiting was noninferior to elective repair. Secondary endpoints included quality of life, event-free survival, and crossover rates.
  
  
  RESULTS
  Between January 2006 and August 2012, 528 patients were enrolled, of whom 496 met the inclusion criteria: 234 were assigned to elective repair and 262 to watchful waiting. The mean pain/discomfort score at 24 months was 0.35 [95% confidence interval (CI) 0.28-0.41)] in the elective repair group and 0.58 (95% CI 0.52-0.64) in the watchful waiting group. The difference of these means (MD) was -0.23 (95% CI -0.32 to -0.14). In the watchful waiting group, 93 patients (35·4%) eventually underwent elective surgery and 6 patients (2·3%) received emergent surgery for strangulation/incarceration. Postoperative complication rates and recurrence rates in these 99 operated individuals were comparable with individuals originally assigned to the elective repair group (8.1% vs 15.0%; P = 0.106, 7.1% vs 8.9%; P = 0.668, respectively).
  
  
  CONCLUSIONS
  Our data could not rule out a relevant difference in favor of elective repair with regard to the primary endpoint. Nevertheless, in view of all other findings, we feel that our results justify watchful waiting as a reasonable alternative compared with surgery in men aged 50 years and older.
authors.affiliation: Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Barry
authors.initials: B
authors.lastname: de Goede
authors.affiliation: Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Arthur R
authors.initials: AR
authors.lastname: Wijsmuller
authors.affiliation: Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Gabrielle H
authors.initials: GH
authors.lastname: van Ramshorst
authors.affiliation: Department of Epidemiology and Radiology, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Bob J
authors.initials: BJ
authors.lastname: van Kempen
authors.affiliation: Department of Biostatistics, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Wim C J
authors.initials: WCJ
authors.lastname: Hop
authors.affiliation: Department of Orthopaedic Surgery, Haga Hospital, Den Haag, The Netherlands.
authors.forename: Pieter J
authors.initials: PJ
authors.lastname: Klitsie
authors.affiliation: Department of Surgery, Maxima Medical Center/SolviMax, Veldhoven/Eindhoven, The Netherlands.
authors.forename: Marc R
authors.initials: MR
authors.lastname: Scheltinga
authors.affiliation: Department of Surgery, Westfries Hospital, Hoorn, The Netherlands.
authors.forename: Jeroen
authors.initials: J
authors.lastname: de Haan
authors.affiliation: Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Walter J B
authors.initials: WJB
authors.lastname: Mastboom
authors.affiliation: Department of Surgery, Maasstad Hospital, Rotterdam, The Netherlands.
authors.forename: Erwin
authors.initials: E
authors.lastname: van der Harst
authors.affiliation: Department of Surgery, Onze Lieve Vrouwe Hospital, Amsterdam, The Netherlands.
authors.forename: Maarten P
authors.initials: MP
authors.lastname: Simons
authors.affiliation: Department of Neuroscience, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Gert-Jan
authors.initials: GJ
authors.lastname: Kleinrensink
authors.affiliation: Department of Neuroscience, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Johannes
authors.initials: J
authors.lastname: Jeekel
authors.affiliation: Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Johan F
authors.initials: JF
authors.lastname: Lange
mesh_terms: D000368:Aged; D058070:Asymptomatic Diseases; D001530:Belgium / Q000453:epidemiology; D018592:Cross-Over Studies; D018450:Disease Progression; D017558:Elective Surgical Procedures / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006552:Hernia, Inguinal / Q000150:complications / Q000601:surgery*; D059685:Herniorrhaphy / Q000379:methods*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D010146:Pain / Q000175:diagnosis* / Q000209:etiology; D010147:Pain Measurement; D011183:Postoperative Complications / Q000453:epidemiology; D013997:Time Factors; D057832:Watchful Waiting / Q000379:methods*