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

Robert Joseph Fitzgibbons, Bala Ramanan, Shipra Arya, Scott A. Turner, Xue Li, James O. Gibbs, Domenic J. Reda

Research output: Contribution to journalArticle

Abstract

Objective: To assess the long-term crossover (CO) rate in men undergoing watchfulwaiting (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 amedian followup 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%). Themost common reason for COwas pain (54.1%).Atotal 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.

Original languageEnglish
Pages (from-to)508-514
Number of pages7
JournalAnnals of Surgery
Volume258
Issue number3
DOIs
StatePublished - Sep 2013

Fingerprint

Watchful Waiting
Inguinal Hernia
Randomized Controlled Trials
Postal Service
Kaplan-Meier Estimate
Emergencies
Research Personnel
Physicians
Pain
Mortality

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. / Fitzgibbons, Robert Joseph; Ramanan, Bala; Arya, Shipra; Turner, Scott A.; Li, Xue; Gibbs, James O.; Reda, Domenic J.

In: Annals of Surgery, Vol. 258, No. 3, 09.2013, p. 508-514.

Research output: Contribution to journalArticle

Fitzgibbons, Robert Joseph ; Ramanan, Bala ; Arya, Shipra ; Turner, Scott A. ; Li, Xue ; Gibbs, James O. ; Reda, Domenic J. / Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. In: Annals of Surgery. 2013 ; Vol. 258, No. 3. pp. 508-514.
@article{24b68a04a4e24ead89119bbb82cf944b,
title = "Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias",
abstract = "Objective: To assess the long-term crossover (CO) rate in men undergoing watchfulwaiting (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 amedian followup 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{\%}). Themost common reason for COwas pain (54.1{\%}).Atotal 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.",
author = "Fitzgibbons, {Robert Joseph} and Bala Ramanan and Shipra Arya and Turner, {Scott A.} and Xue Li and Gibbs, {James O.} and Reda, {Domenic J.}",
year = "2013",
month = "9",
doi = "10.1097/SLA.0b013e3182a19725",
language = "English",
volume = "258",
pages = "508--514",
journal = "Annals of Surgery",
issn = "0003-4932",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

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 Joseph

AU - Ramanan, Bala

AU - Arya, Shipra

AU - Turner, Scott A.

AU - Li, Xue

AU - Gibbs, James O.

AU - Reda, Domenic J.

PY - 2013/9

Y1 - 2013/9

N2 - Objective: To assess the long-term crossover (CO) rate in men undergoing watchfulwaiting (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 amedian followup 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%). Themost common reason for COwas pain (54.1%).Atotal 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.

AB - Objective: To assess the long-term crossover (CO) rate in men undergoing watchfulwaiting (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 amedian followup 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%). Themost common reason for COwas pain (54.1%).Atotal 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.

UR - http://www.scopus.com/inward/record.url?scp=84884504105&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84884504105&partnerID=8YFLogxK

U2 - 10.1097/SLA.0b013e3182a19725

DO - 10.1097/SLA.0b013e3182a19725

M3 - Article

C2 - 24022443

VL - 258

SP - 508

EP - 514

JO - Annals of Surgery

JF - Annals of Surgery

SN - 0003-4932

IS - 3

ER -