Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia

This study has been completed.
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Pr Giampiero CAMPANELLI
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00306839
First received: March 22, 2006
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

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 fibrin sealant (FS), compared to mesh fixation with sutures.


Condition Intervention Phase
Inguinal Hernia
Procedure: standardized Lichtenstein technique
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Combined endpoint evaluating incidence of disabling complications:chronic pain and/or numbness and/or groin discomfort assessed 1 year after surgery.

Secondary Outcome Measures:
  • Recurrence
  • Overall wound-healing complication rate (bleeding complications, bruising, seroma, wound infection, mesh infection)
  • Early postoperative pain at W1 and M1
  • Mid-term postoperative pain at M6
  • Incidence of patients without pain at M1, M6 and M12
  • Use of analgesic drugs
  • Patient's satisfaction
  • Safety (incidence of adverse events)
  • Quality of Life assessed by SF12 pre-operatively or at D-1, M1, M6 and M12
  • Hospital stay (hour or Days) and time to return to normal activities
  • A subgroup analysis will be done for patients receiving pre-operatively aspirin or LMW sub-cutaneous heparin.
  • The study will be blinded for the patient and for the physician evaluating the pain.

Enrollment: 325
Study Start Date: February 2006
Study Completion Date: May 2008
Arms Assigned Interventions
1
Tissel group
Procedure: standardized Lichtenstein technique
2
Suture group
Procedure: standardized Lichtenstein technique

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306839

Locations
Belgium
Gasthuisberg University Hospitals KUL
Leuven, Belgium, 3000
Denmark
Copenhagen university hospital, Gentofte
Hellerup, Denmark, 2900
France
Hôpital Jean Verdier
Bondy, France, 93143
Germany
St. Hildegardis-Krankenhaus
Mainz, Germany, 55131
Spain
Clinica Nuestra Senora del Rosario
Madrid, Spain, 28006
United Kingdom
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
University of Milan
Baxter Healthcare Corporation
Pr Giampiero CAMPANELLI
Investigators
Study Chair: CAMPANELLI Giampiero, Professor
  More Information

No publications provided by University of Milan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00306839     History of Changes
Other Study ID Numbers: TIMELI 001
Study First Received: March 22, 2006
Last Updated: February 12, 2009
Health Authority: Denmark: Danish Medicines Agency
Italy: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut
Spain: Spanish Agency of Medicines

Keywords provided by University of Milan:
Tissucol
Tisseel
Lichtenstein
hernia
inguinal

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014