Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias.

Fitzgibbons RJ Jr1, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial.

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Abstract

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.