Unilateral, uncomplicated primary inguinal hernia repair Classification code 10022020
Conditions
Interventions
Product Name: TISSEEL KIT
Pharmaceutical Form: Powder and solvent for sealant
INN or Proposed INN: Fibrinogen
Concentration unit: mg milligram(s)
Sponsors
Prof. Giampiero CAMPANELLI
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: Hernia reaccurance; wound healing complication rate; early postoperative pain; midterm postoperative pain;incidence of patients without pain; use of analgesic drug; patient satisfaction; quality of life; hospital stay; time to return to normal activities. A subgroup analysis will be dome for patients receiving pre-operative aspirin or LMW sub-cutaneous heparin. ; 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 | — |
Countries
Denmark, Germany, Italy, Spain, United Kingdom
Outcome results
None listed