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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Tissel group

Group Type OTHER

standardized Lichtenstein technique

Intervention Type PROCEDURE

2

Suture group

Group Type OTHER

standardized Lichtenstein technique

Intervention Type PROCEDURE

Interventions

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standardized Lichtenstein technique

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No