Status:
COMPLETED
Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia
Lead Sponsor:
University of Milan
Collaborating Sponsors:
Baxter Healthcare Corporation
Pr Giampiero CAMPANELLI
Conditions:
Inguinal Hernia
Eligibility:
MALE
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate mid and long term postoperative pain and further disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh fixation with fibri...
Detailed Description
Subjects in the FS group will be operated by Lichtenstein technique, with mesh fixation by fibrin sealant. Subjects in control group will be operated with conventional Lichtenstein technique (mesh fix...
Eligibility Criteria
Inclusion
- Signed informed consent obtained from the subject prior to participation in the study
- Active males over the age of 18 years and below 80 years
- 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
- Subjects eligible for elective inguinal hernia repair using Lichtenstein technique.
Exclusion
- Recurrent, scrotal, incarcerated or femoral hernias
- Hernia types L3 and M3 according the EHS classification
- BMI equal or more than 35
- Concomitant abdominal surgery
- Ongoing long term analgesic or steroid treatment
- Patients under Clopidogrel or Warfarin (can be switched to LMW sub-cutaneous heparin)
- Known abuse of alcohol or drugs
- Liver cirrhosis (Child C)
- Previous treatment or Hypersensitivity to bovine aprotinin
- Known immunodeficiency
- Severely compromised physical or psychological health, that in the investigator's opinion will affect patient compliance
- Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00306839
Start Date
February 1 2006
End Date
May 1 2008
Last Update
February 13 2009
Active Locations (6)
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1
Gasthuisberg University Hospitals KUL
Leuven, Belgium, 3000
2
Copenhagen university hospital, Gentofte
Hellerup, Denmark, 2900
3
Hôpital Jean Verdier
Bondy, France, 93143
4
St. Hildegardis-Krankenhaus
Mainz, Germany, 55131