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

University of Milan

Status and phase

Completed

Phase 4

Conditions

Inguinal Hernia

Treatments

Procedure: standardized Lichtenstein technique

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00306839

TIMELI 001

Details and patient eligibility

About

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.

Full 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.

Enrollment

325 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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