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

Phase 2

• Conditions: Inguinal Hernia
• Interventions: Procedure: Lichtenstein operation with a heavy-weight mesh; Procedure: Lichtenstein operation with a light-weight mesh

• Registration Number: NCT00451893
• Lead Sponsor: Umeå University

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-03-23
• Study First Submitted QC: 2007-03-23
• Study First Posted: 2007-03-26
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-01
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heavy-weight	Lichtenstein operation with a heavy-weight mesh	Lichtenstein operation performed with a heavy-weight mesh.
Light-weight	Lichtenstein operation with a light-weight mesh	Lichtenstein operation performed with a light-weight mesh.

Primary Outcome Measures

Name	Time	Method
Pain	Two, seven and eleven postoperative days. Four months and one year after the operation.
Health-related Quality of Life	Two, seven and eleven postoperative days. Four months and one year after the operation.

Secondary Outcome Measures

Name	Time	Method
Recurrences	Four months and one year after the operation.
Health-care costs	Four months and one year after the operation.
Postoperative complications	Four months and one year after the operation.
Sick leave	Four months and one year after the operation.

Trial Locations

Locations (2)

Department of Surgical and Perioperativ Sciences, Umeå University Hospital; 🇸🇪 Umeå, Sweden

Östersund Hospital; 🇸🇪 Östersund, Sweden