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 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. |
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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 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. |
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E.4 | Principal exclusion criteria |
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 |
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E.5 End points |
E.5.1 | Primary end point(s) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 |
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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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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.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 |