Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
NCT ID: NCT00263250
Last Updated: 2013-07-01
Study Results
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Basic Information
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COMPLETED
NA
724 participants
INTERVENTIONAL
1999-02-28
2005-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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watchful waiting or tension-free hernia repair
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Creighton University
OTHER
Responsible Party
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Principal Investigators
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Olga Jonasson, M.D.
Role: STUDY_DIRECTOR
American College of Surgeons
Locations
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American College of Surgeons
Chicago, Illinois, United States
Countries
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References
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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. doi: 10.1001/jama.295.3.285.
Schroeder AD, Tubre DJ, Fitzgibbons RJ Jr. Watchful Waiting for Inguinal Hernia. Adv Surg. 2019 Sep;53:293-303. doi: 10.1016/j.yasu.2019.04.014. Epub 2019 May 15. No abstract available.
Ramanan B, Maloley BJ, Fitzgibbons RJ Jr. Inguinal hernia: follow or repair? Adv Surg. 2014;48:1-11. doi: 10.1016/j.yasu.2014.05.017.
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.
Related Links
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American College of Surgeons
Other Identifiers
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