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 fibrin sealant versus sutures. - TIMILI 001

Phase 1

• Conditions: nilateral, uncomplicated primary inguinal hernia repair; Classification code 10022020

• Registration Number: EUCTR2005-002741-39-GB
• Lead Sponsor: Prof. Giampiero CAMPANELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 328

Inclusion Criteria

1. Written signed informaed consent obtained from the subject prior to participation in the study.

2. Active males over the age of 18 and till 80 years. Active is defined by normal daily activities.

3. Experiencing an uncomplicated unilateral primary inguinal hernia or experiencing an uncomplicated bilateral hernia provided that only one hernia is operated during the 12 months of study follow up.

4. Subjects eligible for elective inguinal hernia repair using the 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, 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, previous treatment 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