Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: A randomized clinical trial

Robert J. Fitzgibbons, Anita Giobbie-Hurder, James O. Gibbs, Dorothy D. Dunlop, Domenic J. Reda, Martin McCarthy, Leigh A. Neumayer, Jeffrey S T Barkun, James L. Hoehn, Joseph T. Murphy, George A. Sarosi, William C. Syme, Jon S Thompson, Jia Wang, Olga Jonasson

Research output: Contribution to journalArticle

263 Citations (Scopus)

Abstract

Context: 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. Design, Setting, and Participants: 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. Interventions: Watchful-waiting patients were followed up at 6 months and annually and watched for hernia symptoms; repair patients received standard open tensionfree repair and were followed up at 3 and 6 months and annually. Main Outcome Measures: 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=.52); 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.

Original languageEnglish (US)
Pages (from-to)285-292
Number of pages8
JournalJournal of the American Medical Association
Volume295
Issue number3
DOIs
StatePublished - Jan 18 2006

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Watchful Waiting
Inguinal Hernia
Randomized Controlled Trials
Hernia
Pain
Outcome Assessment (Health Care)
Clinical Trials

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Fitzgibbons, R. J., Giobbie-Hurder, A., Gibbs, J. O., Dunlop, D. D., Reda, D. J., McCarthy, M., ... Jonasson, O. (2006). Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: A randomized clinical trial. Journal of the American Medical Association, 295(3), 285-292. https://doi.org/10.1001/jama.295.3.285

Watchful waiting vs repair of inguinal hernia in minimally symptomatic men : A randomized clinical trial. / Fitzgibbons, Robert J.; Giobbie-Hurder, Anita; Gibbs, James O.; Dunlop, Dorothy D.; Reda, Domenic J.; McCarthy, Martin; Neumayer, Leigh A.; Barkun, Jeffrey S T; Hoehn, James L.; Murphy, Joseph T.; Sarosi, George A.; Syme, William C.; Thompson, Jon S; Wang, Jia; Jonasson, Olga.

In: Journal of the American Medical Association, Vol. 295, No. 3, 18.01.2006, p. 285-292.

Research output: Contribution to journalArticle

Fitzgibbons, RJ, Giobbie-Hurder, A, Gibbs, JO, Dunlop, DD, Reda, DJ, McCarthy, M, Neumayer, LA, Barkun, JST, Hoehn, JL, Murphy, JT, Sarosi, GA, Syme, WC, Thompson, JS, Wang, J & Jonasson, O 2006, 'Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: A randomized clinical trial', Journal of the American Medical Association, vol. 295, no. 3, pp. 285-292. https://doi.org/10.1001/jama.295.3.285
Fitzgibbons, Robert J. ; Giobbie-Hurder, Anita ; Gibbs, James O. ; Dunlop, Dorothy D. ; Reda, Domenic J. ; McCarthy, Martin ; Neumayer, Leigh A. ; Barkun, Jeffrey S T ; Hoehn, James L. ; Murphy, Joseph T. ; Sarosi, George A. ; Syme, William C. ; Thompson, Jon S ; Wang, Jia ; Jonasson, Olga. / Watchful waiting vs repair of inguinal hernia in minimally symptomatic men : A randomized clinical trial. In: Journal of the American Medical Association. 2006 ; Vol. 295, No. 3. pp. 285-292.
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T1 - Watchful waiting vs repair of inguinal hernia in minimally symptomatic men

T2 - A randomized clinical trial

AU - Fitzgibbons, Robert J.

AU - Giobbie-Hurder, Anita

AU - Gibbs, James O.

AU - Dunlop, Dorothy D.

AU - Reda, Domenic J.

AU - McCarthy, Martin

AU - Neumayer, Leigh A.

AU - Barkun, Jeffrey S T

AU - Hoehn, James L.

AU - Murphy, Joseph T.

AU - Sarosi, George A.

AU - Syme, William C.

AU - Thompson, Jon S

AU - Wang, Jia

AU - Jonasson, Olga

PY - 2006/1/18

Y1 - 2006/1/18

N2 - Context: 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. Design, Setting, and Participants: 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. Interventions: Watchful-waiting patients were followed up at 6 months and annually and watched for hernia symptoms; repair patients received standard open tensionfree repair and were followed up at 3 and 6 months and annually. Main Outcome Measures: 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=.52); 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.

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