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Long-term Results of a Randomized Controlled Trial of a Nonoperative Strategy (Watchful Waiting) for Men With Minimally Symptomatic Inguinal Hernias

Fitzgibbons, Robert J. Jr MD, FACS*; Ramanan, Bala MBBS*; Arya, Shipra MD*; Turner, Scott A. MD*; Li, Xue MA, PhD; Gibbs, James O. PhD*; Reda, Domenic J. PhD†;

doi: 10.1097/SLA.0b013e3182a19725
Papers of the 133rd ASA Annual Meeting

Objective: To assess the long-term crossover (CO) rate in men undergoing watchful waiting (WW) as a primary treatment strategy for their asymptomatic or minimally symptomatic inguinal hernias.

Background: With an average follow-up of 3.2 years, a randomized controlled trial comparing WW with routine repair for male patients with minimally symptomatic inguinal hernias led investigators to conclude that WW was an acceptable option [JAMA. 2006;295(3):285–292]. We now analyze patients in the WW group after an additional 7 years of follow-up.

Methods: At the conclusion of the original study, 254 men who had been assigned to WW consented to longer-term follow-up. These patients were contacted yearly by mail questionnaire. Nonresponders were contacted by phone or e-mail for additional data collection.

Results: Eighty-one of the 254 men (31.9%) crossed over to surgical repair before the end of the original study, December 31, 2004, with a median follow-up of 3.2 (range: 2–4.5) years. The patients have now been followed for an additional 7 years with a maximum follow-up of 11.5 years. The estimated cumulative CO rates using Kaplan-Meier analysis was 68%. Men older than 65 years crossed over at a considerably higher rate than younger men (79% vs 62%). The most common reason for CO was pain (54.1%). A total of 3 patients have required an emergency operation, but there has been no mortality.

Conclusions: Men who present to their physicians because of an inguinal hernia even when minimally symptomatic should be counseled that although WW is a reasonable and safe strategy, symptoms will likely progress and an operation will be needed eventually.

A randomized controlled trial ending in 2004 dealing with a strategy of watchful waiting (WW) versus routine repair for men with minimally symptomatic inguinal hernia concluded that WW was reasonable. In this article, we analyze those patients assigned to WW after an additional 7 years to provide long-term follow-up for this cohort.

*Department of Surgery, Creighton University, Omaha, NE

Hines VA Hospital, Cooperative Study Program Coordinator Center, Hines, IL.

Reprints: Robert J. Fitzgibbons, Jr, MD, FACS, Division of General Surgery, Department of Surgery, Creighton University, Omaha, NE 68131; E-mail:

#The list of investigators of the original trial is given in Table 1.

Disclosure: The baseline study was funded by Agency for Healthcare Research and Quality grant RO1 HS 09860. The registry was supported by a grant from the American College of Surgeons and internal funds, Creighton University, Department of Surgery. The authors declare no conflicts of interest.

Clinical Trials Registration— Identifier: NCT00263250

© 2013 by Lippincott Williams & Wilkins.