Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia
Prospective, Controlled, Randomized 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
Study Overview
Status
Conditions
Intervention / Treatment
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 fixation by sutures).
Hernia repair will be performed according to standardized Lichtenstein technique, a technique for tension free hernioplasty. A Polypropylene, heavyweight, macroporous mesh will be used (8x15 cm) tailored to individual patients requirement. The different ways of mesh fixation will be randomly assigned within 24 hours before the operation. In the FS group, the two tails of the mesh will be fixed together in overlapping their edges and by surrounding the cord. The edges will be joined up to by 1 suture. No other sutures will be used. First the mesh will be put correctly in place. A small spot (0.5ml) of FS will be applied on the pubis under the mesh without spray then the remaining part (3,5ml) over the mesh on the entire surface in a thin uniform layer by spray. 2 ml Tissucol-Tisseel (4 ml of fibrin sealant) will be used per mesh. In the control group, the mesh will be fixed in a conventional manner. Nerve resection (if occurred) will be recorded; it should be avoided.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- Gasthuisberg University Hospitals KUL
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Hellerup, Denmark, 2900
- Copenhagen University hospital, Gentofte
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Bondy, France, 93143
- Hôpital Jean Verdier
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Mainz, Germany, 55131
- St. Hildegardis-Krankenhaus
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Madrid, Spain, 28006
- Clinica Nuestra Senora del Rosario
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Plymouth, United Kingdom, PL6 8DH
- Derriford Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: 1
Tissel group
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Other: 2
Suture group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Combined endpoint evaluating incidence of disabling complications:chronic pain and/or numbness and/or groin discomfort assessed 1 year after surgery.
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Secondary Outcome Measures
Outcome Measure |
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Recurrence
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Overall wound-healing complication rate (bleeding complications, bruising, seroma, wound infection, mesh infection)
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Early postoperative pain at W1 and M1
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Mid-term postoperative pain at M6
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Incidence of patients without pain at M1, M6 and M12
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Use of analgesic drugs
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Patient's satisfaction
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Safety (incidence of adverse events)
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Quality of Life assessed by SF12 pre-operatively or at D-1, M1, M6 and M12
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Hospital stay (hour or Days) and time to return to normal activities
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A subgroup analysis will be done for patients receiving pre-operatively aspirin or LMW sub-cutaneous heparin.
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The study will be blinded for the patient and for the physician evaluating the pain.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: CAMPANELLI Giampiero, Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIMELI 001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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