Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia - Full Text View

Sponsors and Collaborators:	University of Milan Baxter Healthcare Corporation Pr Giampiero CAMPANELLI
Information provided by:	University of Milan
ClinicalTrials.gov Identifier:	NCT00306839

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Hernia

Drug Information available for: Beriplast Fibrin

U.S. FDA Resources

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

unaffiliated

More Information

No publications provided

Study ID Numbers:	TIMELI 001
Study First Received:	March 22, 2006
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00306839 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Italy: Ethics Committee; France: Afssaps - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Fibrin Tissue Adhesive
Hernia
Hernia, Abdominal

Pain
Hernia, Inguinal
Hemostatics

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Coagulants
Fibrin Tissue Adhesive
Therapeutic Uses
Hernia

Hematologic Agents
Hernia, Abdominal
Hernia, Inguinal
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on September 11, 2009