Inguinal hernia management: operation or observation? A randomised controlled multicentre trial
- Conditions
- Hernia InguinalDigestive SystemInguinal hernia
- Registration Number
- ISRCTN31866667
- Lead Sponsor
- Erasmus Medical Centre (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 800
1. Unilateral inguinal hernia
2. Males
3. Medial or lateral inguinal hernia
4. Aged greater than or equal to 50 years
5. Description I or II of pain or discomfort interfering with daily activity
6. Primary or recurrent inguinal hernia
7. Informed consent (addendum V)
1. Gender: female
2. Bilateral inguinal hernia
3. Femoral hernia
4. Description III or IV of pain or discomfort interfering with daily activity
5. Acute hernia complication (bowel obstruction, incarceration, strangulation, peritonitis or perforation)
6. Patient classified as American Society of Anaesthesiologist Class 4
7. Scrotal hernia (cannot be corrected laparoscopically)
8. Patient is unable to speak Dutch
9. Physical activity: patient travels regularly during which professional medical help is not always accessible
10. Inguinal hernia not apparent during ultrasonography
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean of 4 pain/discomfort scores during a follow-up period of 3 years.
- Secondary Outcome Measures
Name Time Method Quality adjusted life years (QALY) with quality weights measured with the EuroQol and in a sensitivity analysis with a transformed 36-item short form (SF-36) utility weight, medical and non-medical costs and event-free survival at 2 years.