The Significance of the Mesh Thickness in the Operation of Inguinal Hernia

Study Overview
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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.

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.

Official Title
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An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Lichtenstein operation with a heavy-weight mesh
* Procedure: Lichtenstein operation with a light-weight mesh


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heavy-weight<br>Lichtenstein operation performed with a heavy-weight mesh. | Procedure: Lichtenstein operation with a heavy-weight mesh<br>* Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2<br>|
| Active Comparator: Light-weight<br>Lichtenstein operation performed with a light-weight mesh. | Procedure: Lichtenstein operation with a light-weight mesh<br>* Johnson&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life |  | Two, seven and eleven postoperative days. Four months and one year after the operation. | 
| Pain |  | Two, seven and eleven postoperative days. Four months and one year after the operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications |  | Four months and one year after the operation. | 
| Recurrences |  | Four months and one year after the operation. | 
| Health-care costs |  | Four months and one year after the operation. | 
| Sick leave |  | Four months and one year after the operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal hernia, polypropylene mesh, heavy-weight mesh, light-weight mesh