The Total Extra Peritoneal (TEP) method versus the Transinguinal Preperitoneal Technique (TIPP) for inguinal hernia repair.
Completed
- Conditions
- Inguinal herniaSurgery
- Registration Number
- ISRCTN26433218
- Lead Sponsor
- Radboud University Medical Centre, Nijmegen (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 900
Inclusion Criteria
1. Primary groin hernia, unilateral
2. Age > 18, < 80 years
3. American Society of Anaesthesiologists (ASA) classification 1-3
4. Signed informed consent
Exclusion Criteria
1. Recurrences
2. Age <18 or >80 years
3. Scrotal hernia
4. ASA classification >4
5. Acute incarcerated inguinal hernia
6. Psychiatric disease or other factors which make follow up or questionnaires unreliable
7. Previous preperitoneal surgery (e.g. radical prostatectomy)
8. Joint sessions (urology, vasectomy etc.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Incidence of adverse events<br>2. Chronic pain (Visual Analogue Score [VAS])<br>Data will be collected by VAS-diary and SF36-list (Health Status / Quality of Life). Digital forms will be filled in by the patients at the outpatient departments at 14 days, 3 months and one year after surgery.
- Secondary Outcome Measures
Name Time Method 1. Costs<br>2. Quality of life (SF-36)<br>3. Return to daily activities<br>4. Return to work<br>Data will be collected by VAS-diary and SF36-list (Health Status / Quality of Life). Digital forms will be filled in by the patients at the outpatient departments at 14 days, 3 months and one year after surgery.