Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
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|ClinicalTrials.gov Identifier: NCT00263250|
Recruitment Status : Completed
First Posted : December 8, 2005
Last Update Posted : July 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Inguinal Hernia||Procedure: watchful waiting or tension-free hernia repair||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||724 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Pain limiting usual activities at two years.
- Physical function (PCS) at two years.
- patient-reported outcomes of pain, functional status, activity levels, and satisfaction with care.
- Cost effectiveness.
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 ClinicalTrials.gov identifier (NCT number): NCT00263250
|United States, Illinois|
|American College of Surgeons|
|Chicago, Illinois, United States, 60610|
|Study Director:||Olga Jonasson, M.D.||American College of Surgeons|