E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unilateral, uncomplicated primary inguinal hernia repair |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10022020 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Open to surgeon, blinded to evaluator |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Sutures for mesh fixation in hernioplasty |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last evaluation visit at 1 year for the last patient enrolled. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 21 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 21 |