title: Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial.
abstract: BACKGROUND
  Many men with inguinal hernia have minimal symptoms. Whether deferring surgical repair is a safe and acceptable option has not been assessed.
  
  
  OBJECTIVE
  To compare pain and the physical component score (PCS) of the Short Form-36 Version 2 survey at 2 years in men with minimally symptomatic inguinal hernias treated with watchful waiting or surgical repair.
  
  
  METHODS
  Randomized trial conducted January 1, 1999, through December 31, 2004, at 5 North American centers and enrolling 720 men (364 watchful waiting, 356 surgical repair) followed up for 2 to 4.5 years.
  
  
  METHODS
  Watchful-waiting patients were followed up at 6 months and annually and watched for hernia symptoms; repair patients received standard open tension-free repair and were followed up at 3 and 6 months and annually.
  
  
  METHODS
  Pain and discomfort interfering with usual activities at 2 years and change in PCS from baseline to 2 years. Secondary outcomes were complications, patient-reported pain, functional status, activity levels, and satisfaction with care.
  
  
  RESULTS
  Primary intention-to-treat outcomes were similar at 2 years for watchful waiting vs surgical repair: pain limiting activities (5.1% vs 2.2%, respectively; P = .06 [corrected]); PCS (improvement over baseline, 0.29 points vs 0.13 points; P = .79). Twenty-three percent of patients assigned to watchful waiting crossed over to receive surgical repair (increase in hernia-related pain was the most common reason offered); 17% assigned to receive repair crossed over to watchful waiting. Self-reported pain in watchful-waiting patients crossing over improved after repair. Occurrence of postoperative hernia-related complications was similar in patients who received repair as assigned and in watchful-waiting patients who crossed over. One watchful-waiting patient (0.3%) experienced acute hernia incarceration without strangulation within 2 years; a second had acute incarceration with bowel obstruction at 4 years, with a frequency of 1.8/1000 patient-years inclusive of patients followed up for as long as 4.5 years.
  
  
  CONCLUSIONS
  Watchful waiting is an acceptable option for men with minimally symptomatic inguinal hernias. Delaying surgical repair until symptoms increase is safe because acute hernia incarcerations occur rarely.Clinical Trials Registration ClinicalTrials.gov Identifier: NCT00263250.
authors.affiliation: Department of Surgery, Creighton University, Omaha, Neb, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Fitzgibbons
authors.forename: Anita
authors.initials: A
authors.lastname: Giobbie-Hurder
authors.forename: James O
authors.initials: JO
authors.lastname: Gibbs
authors.forename: Dorothy D
authors.initials: DD
authors.lastname: Dunlop
authors.forename: Domenic J
authors.initials: DJ
authors.lastname: Reda
authors.forename: Martin
authors.initials: M
authors.lastname: McCarthy
authors.forename: Leigh A
authors.initials: LA
authors.lastname: Neumayer
authors.forename: Jeffrey S T
authors.initials: JS
authors.lastname: Barkun
authors.forename: James L
authors.initials: JL
authors.lastname: Hoehn
authors.forename: Joseph T
authors.initials: JT
authors.lastname: Murphy
authors.forename: George A
authors.initials: GA
authors.lastname: Sarosi
authors.forename: William C
authors.initials: WC
authors.lastname: Syme
authors.forename: Jon S
authors.initials: JS
authors.lastname: Thompson
authors.forename: Jia
authors.initials: J
authors.lastname: Wang
authors.forename: Olga
authors.initials: O
authors.lastname: Jonasson
mesh_terms: D000328:Adult; D000368:Aged; D018450:Disease Progression; D005500:Follow-Up Studies; D006552:Hernia, Inguinal / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain; D017060:Patient Satisfaction; D012720:Severity of Illness Index; D013526:Surgical Mesh