Inguinal Hernia
Conditions
Keywords
Inguinal hernia, polypropylene mesh, heavy-weight mesh, light-weight mesh
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.
Interventions
Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
Johnson\&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain measured with pain assessment scale | Four months after the operation. | McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain. |
| Health-related Quality of Life measured with EQ-5D index | One year after the operation. | The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels. |
| Postoperative pain measured with pain assessment scale for inguinal pain | 10 years | Inguinal Pain Questionnaire for assessing impact on daily activities. The short form of Inguinal Pain Questionnaire has 7 grades (1-7). Increasing grade means more pain. Grade 1 represents no pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life measured with EQ-5D index | 2 days after the operation | The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels. |
| Postoperative complications | Within one year after the operation. | Description and frequency of postoperative complications |
| Recurrences | Within one year after the operation. | Recurrences of inguinal hernia |
| Health-care costs | Within one year after the operation. | Total health-care costs |
| Sick leave | Within one year after the operation. | Post operative sick leave |
Countries
Sweden
Contacts
Umeå University, Department of Surgical and Perioperative Sciences
Umeå University, Department of Surgical and Perioperative Sciences
Umeå University, Department of Surgical and Perioperative Sciences
Umeå University, Department of Surgical and Perioperative Sciences