The Significance of the Mesh Thickness in the Operation of 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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2016-11-30

Brief Summary

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The trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes.

Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.

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Detailed Description

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The implantation of mesh in the operation of inguinal hernia has resulted in a continuously diminishing frequency of reoperations. Randomized controlled trials indicate that hernia repair with an open mesh technique has a shorter learning curve, is cheaper and may give less recurrences than laparoscopic hernia repair in general surgical practice. Furthermore, local anesthesia has significant advantages for both the patient and the health related economy compared to general anesthesia and regional anesthesia. The experience of the last decade within the field of groin hernia surgery has focused interest on quality of life and postoperative pain (especially chronic pain). Chronic pain is defined as pain that remains 3 months after the operation. Recent studies indicate that one third of all patients operated on for inguinal hernia have some degree of chronic pain and that 4-6 % of patients have pain interfering with daily activities one year after surgery.

In the present study a heavy-weight polypropylene mesh will be compared with a light-weight partly absorbable mesh. In an expertise-based randomized control trial patients will be randomly allocated to two groups of surgeons, each group well trained to use one of the two meshes.

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

SINGLE

Outcome Assessors

Study Groups

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Heavy-weight

Lichtenstein operation performed with a heavy-weight mesh.

Group Type ACTIVE_COMPARATOR

Lichtenstein operation with a heavy-weight mesh

Intervention Type PROCEDURE

Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2

Light-weight

Lichtenstein operation performed with a light-weight mesh.

Group Type ACTIVE_COMPARATOR

Lichtenstein operation with a light-weight mesh

Intervention Type PROCEDURE

Johnson\&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2

Interventions

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Lichtenstein operation with a heavy-weight mesh

Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2

Intervention Type PROCEDURE

Lichtenstein operation with a light-weight mesh

Johnson\&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male, age 25 years or older
* Reducible, unilateral, inguinal hernia (not femoral hernia) that has not been operated on before

Exclusion Criteria

* The patient is not able or do not want to give written informed consent
* The patient is not suitable for an operation in local anesthesia
* Anticoagulant medication or a known coagulation disorder

Minimum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No