The Significance of the Mesh Thickness in the Operation of Inguinal Hernia (LJUNO)

Umeå University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Inguinal Hernia

Treatments: Procedure: Lichtenstein operation with a light-weight mesh; Procedure: Lichtenstein operation with a heavy-weight mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT00451893

LJUNO 05-109M

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: Male

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Heavy-weight

Active Comparator group

Description:

Lichtenstein operation performed with a heavy-weight mesh.

Treatment:

Procedure: Lichtenstein operation with a heavy-weight mesh

Light-weight

Active Comparator group

Description:

Lichtenstein operation performed with a light-weight mesh.

Treatment:

Procedure: Lichtenstein operation with a light-weight mesh