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
- Conditions
- Subjects requiring a unilateral tension-free hernioplasty by Lichtenstein technique.MedDRA version: 6.1Level: PTClassification code 10022020
- Registration Number
- EUCTR2005-002741-39-IT
- Lead Sponsor
- OSPEDALE MAGGIORE DI MILANO IRCCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 328
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to evaluate disabling complications Chronic pain and/or Numbness and/or Groin discomfort in open inguinal hernia repair by Lichtenstein technique after mesh fixation with Tissucol-Tisseel fibrin sealant FS , compared to mesh fixation with sutures.;Secondary Objective: not defined;Primary end point(s): Combined endpoint evaluating incidence of disabling complications chronic pain and/or numbness and/or groin discomfort assessed 1 year after surgery
- Secondary Outcome Measures
Name Time Method