EUCTR2005-002741-39-ITActive, not recruitingNot Applicable
A prospective, controlled, randomized, patient and evaluator blinded study to evaluate pain and further disabling complications in patients undergoing Lichtenstein technique for primary inguinal hernia repair by fixing the mesh with Tissucol/Tisseel fibrin sealant versus sutures - TI.ME.LI. study
OSPEDALE MAGGIORE DI MILANO IRCCS0 sites328 target enrollmentStarted: August 4, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 328
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •1. Signed informed consent obtained from the subject prior to participation in the study 2. Active males over the age of 18 years and below 70 years 3. Experiencing an uncomplicated unilateral primary inguinal hernia 4. Subjects eligible for elective inguinal hernia repair using Lichtenstein technique
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Recurrent, bilateral, scrotal, incarcerated or femoral hernias 2. Hernia types L3 and M3 according the EHS classification 3. BMI equal or more than 35 4. Concomitant abdominal surgery 5. Ongoing long term analgesic or steroid treatment 6. Patients under Clopidogrel or Warfarin can be switched to LMW sub-cutaneous heparin 7. Known abuse of alcohol or drugs 8. Liver cirrhosis Child C 9. Hypersensitivity to bovine aprotinin 10. Known immunodeficiency 11. Severely compromised physical or psychological health, that in the investigator s opinion will affect patient compliance 12. Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
Investigators
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