Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial |
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| Authors: | 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 |
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| Affiliation: | Department of Surgery, Creighton University, Omaha, Neb (Dr Fitzgibbons); Department of Surgery, Omaha VA Medical Center, Omaha (Drs Fitzgibbons and Thompson); VA Cooperative Studies Program Coordinating Center, Hines, Ill (Dr Reda and Mss Giobbie-Hurder and Wang); Department of Preventive Medicine (Dr McCarthy) and Institute for Healthcare Studies (Drs Dunlop and Gibbs), Northwestern University, Chicago, Ill; Salt Lake City VA Health Care System and Department of Surgery, University of Utah, Salt Lake City (Dr Neumayer); Department of Surgery, McGill University, Montreal, Quebec (Dr Barkun); Marshfield Clinic Department of Surgery, Marshfield, Wis (Dr Hoehn); University of Texas Southwestern Medical Center at Dallas and Department of Surgery, Dallas VA Medical Center, Dallas, Tex (Drs Murphy and Sarosi); Lovelace Clinic Department of Surgery, Albuquerque, NM (Dr Syme); Department of Surgery, University of Nebraska, Omaha (Dr Thompson); and Department of Surgery, University of Illinois, Chicago (Dr Jonasson). |
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| 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 tension-free 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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