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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
412
Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
Johnson\&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2
Östersund Hospital
Östersund, Sweden
Department of Surgical and Perioperativ Sciences, Umeå University Hospital
Umeå, Sweden
Postoperative pain measured with pain assessment scale
McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain.
Time frame: Four months after the operation.
Postoperative pain measured with pain assessment scale
McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain.
Time frame: One year after the operation.
Health-related Quality of Life measured with EQ-5D index
The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Time frame: One year after the operation.
Postoperative pain measured with pain assessment scale for inguinal pain
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.
Time frame: 10 years
Health related quality of life measured with EQ-5D index
The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Time frame: 2 days after the operation
Health related quality of life measured with EQ-5D index
The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Time frame: Seven days after the operation.
Health related quality of life measured with EQ-5D index
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The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Time frame: Eleven days after the operation.
Health related quality of life measured with EQ-5D index
The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Time frame: Four months after the operation
Postoperative complications
Description and frequency of postoperative complications
Time frame: Within one year after the operation.
Recurrences
Recurrences of inguinal hernia
Time frame: Within one year after the operation.
Health-care costs
Total health-care costs
Time frame: Within one year after the operation.
Sick leave
Post operative sick leave
Time frame: Within one year after the operation.