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| Name | Class |
|---|---|
| Norrlandstingens Regionfƶrbund | OTHER |
| JƤmtland County Council, Sweden | OTHER_GOV |
| VƤsterbotten County Council, Sweden | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heavy-weight | Active Comparator | Lichtenstein operation performed with a heavy-weight mesh. |
|
| Light-weight | Active Comparator | Lichtenstein operation performed with a light-weight mesh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lichtenstein operation with a heavy-weight mesh | Procedure | Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain measured with pain assessment scale | McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain. | 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. | 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. | 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 days after the operation |
| Health related quality of life measured with EQ-5D index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markku M Haapamaki, MD, PhD | UmeƄ University, Department of Surgical and Perioperative Sciences | Principal Investigator |
| Erik Nilsson, MD, Ph D | UmeƄ University, Department of Surgical and Perioperative Sciences | Study Director |
| PƤr Nordin, MD, PhD | UmeƄ University, Department of Surgical and Perioperative Sciences | Principal Investigator |
| Martin RutegƄrd, MD, PhD | UmeƄ University, Department of Surgical and Perioperative Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ćstersund Hospital | Ćstersund | SE 83183 | Sweden | |||
| Department of Surgical and Perioperativ Sciences, UmeƄ University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29353339 | Result | Rutegard M, Gumuscu R, Stylianidis G, Nordin P, Nilsson E, Haapamaki MM. Chronic pain, discomfort, quality of life and impact on sex life after open inguinal hernia mesh repair: an expertise-based randomized clinical trial comparing lightweight and heavyweight mesh. Hernia. 2018 Jun;22(3):411-418. doi: 10.1007/s10029-018-1734-z. Epub 2018 Jan 20. | |
| 33711123 |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lichtenstein operation with a light-weight mesh | Procedure | Johnson&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2 |
|
The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels. |
| Seven 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. | 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. | Four months after the operation |
| Postoperative complications | Description and frequency of postoperative complications | Within one year after the operation. |
| Recurrences | Recurrences of inguinal hernia | Within one year after the operation. |
| Health-care costs | Total health-care costs | Within one year after the operation. |
| Sick leave | Post operative sick leave | Within one year after the operation. |
| UmeƄ |
| SE 90185 |
| Sweden |
| Rutegard M, Lindqvist M, Svensson J, Nordin P, Haapamaki MM. Chronic pain after open inguinal hernia repair: expertise-based randomized clinical trial of heavyweight or lightweight mesh. Br J Surg. 2021 Mar 12;108(2):138-144. doi: 10.1093/bjs/znaa049. |