Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men

Study Description

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Brief Summary:

This is a multicenter clinical trial to compare pain, physical function, and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernias randomly assigned to watchful waiting without an operation, or a standard hernia repair with mesh. We studied the safety of delaying operation.

Condition or disease	Intervention/treatment	Phase
Inguinal Hernia	Procedure: watchful waiting or tension-free hernia repair	Not Applicable

Detailed Description:

CONTEXT Many men with an inguinal hernia have minimal symptoms. Whether deferring operation is safe and a good option for some patients has not been assessed.

OBJECTIVE To compare pain and the Physical Component Score (PCS) of the SF-36 at two years in men with minimally symptomatic inguinal hernias randomized to watchful waiting (WW) or a standard tension-free hernia repair (TFR).

DESIGN, SETTING, AND PATIENTS. Between January, 1999 and December, 2004 we conducted a multicenter trial of 720 men (364 WW, 356 TFR) who were followed for 2-4.5 years. Men were excluded with hernia pain interfering with activities; undetectable hernias; infection; American Society of Anesthesiologists Physical Status >3; recent difficulty in reducing the hernia.

INTERVENTIONS Men assigned to WW were followed at 6 months and annually and watched for hernia symptoms. Men assigned to operation received TFR, and were followed at 3 and 6 months, and annually.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	724 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
Study Start Date :	February 1999
Actual Primary Completion Date :	December 2004
Actual Study Completion Date :	February 2005

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Pain limiting usual activities at two years.
2. Physical function (PCS) at two years.

Secondary Outcome Measures :

1. Complications
2. patient-reported outcomes of pain, functional status, activity levels, and satisfaction with care.
3. Cost effectiveness.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: men 18 years of age and older with asymptomatic or minimally symptomatic inguinal hernias who give informed consent to be randomized.

Exclusion Criteria:Presence of pain limiting usual activities, difficulty in reducing hernia within last 6 weeks, undetectable hernias, local or systemic infection, ASA physical status >3, or participation in another clinical trial.

Contacts and Locations

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Locations

United States, Illinois
American College of Surgeons
Chicago, Illinois, United States, 60610

Sponsors and Collaborators

Creighton University

Investigators

Study Director:	Olga Jonasson, M.D.	American College of Surgeons

More Information

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Additional Information:

American College of Surgeons 

Publications of Results:

Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, Dunlop DD, Reda DJ, McCarthy M Jr, Neumayer LA, Barkun JS, Hoehn JL, Murphy JT, Sarosi GA Jr, Syme WC, Thompson JS, Wang J, Jonasson O. Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA. 2006 Jan 18;295(3):285-92. Erratum in: JAMA. 2006 Jun 21;295(23):2726.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ramanan B, Maloley BJ, Fitzgibbons RJ Jr. Inguinal hernia: follow or repair? Adv Surg. 2014;48:1-11. Review.

Fitzgibbons RJ Jr, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013 Sep;258(3):508-15. doi: 10.1097/SLA.0b013e3182a19725.

Sarosi GA, Wei Y, Gibbs JO, Reda DJ, McCarthy M, Fitzgibbons RJ, Barkun JS. A clinician's guide to patient selection for watchful waiting management of inguinal hernia. Ann Surg. 2011 Mar;253(3):605-10. doi: 10.1097/SLA.0b013e31820b04e9.

Responsible Party:	Creighton University
ClinicalTrials.gov Identifier:	NCT00263250 History of Changes
Other Study ID Numbers:	R01HS009860 ( U.S. AHRQ Grant/Contract )
First Posted:	December 8, 2005
Last Update Posted:	July 1, 2013
Last Verified:	June 2013

Keywords provided by Creighton University:

inguinal hernia; asymptomatic; watchful waiting; tension-free hernia repair

Additional relevant MeSH terms:

Hernia; Hernia, Inguinal; Pathological Conditions, Anatomical; Hernia, Abdominal