inguinal hernia
Conditions
Interventions
1. Operation
2. No intervention, observational management of the inguinal hernia.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Unilateral inguinal hernia; 2. Males; 3. Medial or lateral inguinal hernia; 4. Age ¡Ý 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean of 4 pain/discomfort scores during a follow-up period of 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality Adjusted Life Years (QALY) with quality weights measured with the EuroQol and in a sensitivity analysis with a transformed SF-36 utility weight, medical and non-medical costs and the event-free survival at 2 years. | — |
Contacts
Public ContactJ. Jeekel
Erasmus Medical Center, Department of General Surgery, Molewaterplein 40/50
Outcome results
None listed