Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
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Purpose
| Condition | Intervention |
|---|---|
| Inguinal Hernia | Procedure: watchful waiting or tension-free hernia repair |
| Study Type: | Interventional |
| Study Design: | 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 |
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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.
Contacts and Locations
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 |
More Information
Additional Information:
Publications:
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: |
R01HS009860 ( U.S. AHRQ Grant/Contract ) |
| First Submitted: | December 6, 2005 |
| First Posted: | December 8, 2005 |
| Last Update Posted: | October 12, 2017 |
| 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 |