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 REPAIRBY FIXING THE MESH WITH TISSUCOL/TISSEEL FIBRIN SEALANT VERSUS SUTURES - TI.ME.LI. study
- Conditions
- nilateral, uncomplicated primary inguinal hernia repairClassification code 10022020
- Registration Number
- EUCTR2005-002741-39-DE
- Lead Sponsor
- Pr Giampiero CAMPANELLI Università di Milano, Dipartimento di Scienze Chirurgiche, Ospedale Maggior
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 328
1. Written signed informed consent obtained from the subject prior to participation in the study.
2. Active males over the age of 18 years and till 70 years. Active is defined by having normal daily activities.
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?
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 European Hernia Society classification assessed pre or intra-operatively
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’s 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: To evaluate mid and long term postoperative pain and further disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh fixation with fibrin sealant (FS), compared to mesh fixation with sutures. ;Secondary Objective: In addition further parameters will be assessed as secondary endpoints.<br>Hernia recurrence; wound-healing complication rate; early postoperative pain; Mid-term post-operative pain; Incidence of patients without pain; Use of analgesic drug; Patient’s satisfaction; Safety; Quality of Life; Hospital stay; time to return to normal activities. A subgroup analysis will be done for patients receiving pre-operatively aspirin or LMW sub-cutaneous heparin.<br>;Primary end point(s): The primary efficacy endpoint will be disabling complications 12 months after surgery. This combined endpoint consists of Chronic pain and/or Numbness and/or Groin discomfort
- Secondary Outcome Measures
Name Time Method