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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.
Ann Surg 2013; 258(3):508-15AnnS

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.

Authors+Show Affiliations

*Department of Surgery, Creighton University, Omaha, NE †Hines VA Hospital, Cooperative Study Program Coordinator Center, Hines, IL.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

24022443

Citation

Fitzgibbons, Robert J., et al. "Long-term Results of a Randomized Controlled Trial of a Nonoperative Strategy (watchful Waiting) for Men With Minimally Symptomatic Inguinal Hernias." Annals of Surgery, vol. 258, no. 3, 2013, pp. 508-15.
Fitzgibbons RJ, Ramanan B, Arya S, et al. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013;258(3):508-15.
Fitzgibbons, R. J., Ramanan, B., Arya, S., Turner, S. A., Li, X., Gibbs, J. O., & Reda, D. J. (2013). Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Annals of Surgery, 258(3), pp. 508-15. doi:10.1097/SLA.0b013e3182a19725.
Fitzgibbons RJ, et al. Long-term Results of a Randomized Controlled Trial of a Nonoperative Strategy (watchful Waiting) for Men With Minimally Symptomatic Inguinal Hernias. Ann Surg. 2013;258(3):508-15. PubMed PMID: 24022443.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. AU - Fitzgibbons,Robert J,Jr AU - Ramanan,Bala, AU - Arya,Shipra, AU - Turner,Scott A, AU - Li,Xue, AU - Gibbs,James O, AU - Reda,Domenic J, AU - ,, PY - 2013/9/12/entrez PY - 2013/9/12/pubmed PY - 2013/11/19/medline SP - 508 EP - 15 JF - Annals of surgery JO - Ann. Surg. VL - 258 IS - 3 N2 - 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. SN - 1528-1140 UR - https://www.unboundmedicine.com/medline/citation/24022443/Long_term_results_of_a_randomized_controlled_trial_of_a_nonoperative_strategy__watchful_waiting__for_men_with_minimally_symptomatic_inguinal_hernias_ L2 - http://Insights.ovid.com/pubmed?pmid=24022443 DB - PRIME DP - Unbound Medicine ER -