Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
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Purpose
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 | Intervention |
|---|---|
|
Inguinal Hernia |
Procedure: watchful waiting or tension-free hernia repair |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men |
- Pain limiting usual activities at two years.
- Physical function (PCS) at two years.
- Complications
- patient-reported outcomes of pain, functional status, activity levels, and satisfaction with care.
- Cost effectiveness.
| Estimated Enrollment: | 724 |
| Study Start Date: | February 1999 |
| Study Completion Date: | February 2005 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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.
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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.
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Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00263250
| United States, Illinois | |
| American College of Surgeons | |
| Chicago, Illinois, United States, 60610 | |
| Study Director: | Olga Jonasson, M.D. | American College of Surgeons |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Creighton University |
| ClinicalTrials.gov Identifier: | NCT00263250 History of Changes |
| Other Study ID Numbers: | RO1 HS 09860 |
| Study First Received: | December 6, 2005 |
| Last Updated: | June 28, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Creighton University:
|
inguinal hernia asymptomatic watchful waiting tension-free hernia repair |
Additional relevant MeSH terms:
|
Hernia Hernia, Inguinal Hernia, Abdominal Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on February 27, 2015