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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00263250
Recruitment Status : Completed
First Posted : December 8, 2005
Last Update Posted : July 1, 2013
Information provided by (Responsible Party):
Creighton University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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.

Information from the National Library of Medicine

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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00263250

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United States, Illinois
American College of Surgeons
Chicago, Illinois, United States, 60610
Sponsors and Collaborators
Creighton University
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Study Director: Olga Jonasson, M.D. American College of Surgeons
Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Creighton University Identifier: NCT00263250    
Other Study ID Numbers: R01HS009860 ( U.S. AHRQ Grant/Contract )
First Posted: December 8, 2005    Key Record Dates
Last Update Posted: July 1, 2013
Last Verified: June 2013
Keywords provided by Creighton University:
inguinal hernia
watchful waiting
tension-free hernia repair
Additional relevant MeSH terms:
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Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal