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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| North Karelia Central Hospital | OTHER |
| Mikkeli Central Hospital | OTHER |
| Päijänne Tavastia Central Hospital |
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Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Immediate and late complications are also analyzed.
Patient characteristics are recorded before surgery. The adult patients with inguinal hernia are randomized into endoscopic totally extraperitoneal hernioplasty (TEP) or open Lichtenstein hernioplasty. Pain reaction to surgery and return to work are asked many times using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). Surgical complications and use of pain killers are carefully recorded. Clinical examination is performed if necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic TEP surgery | Active Comparator | Routine total extraperitoneal technique surgery for inguinal hernia |
|
| Open Lichtenstein hernioplasty | Active Comparator | Routine lichtenstein surgery for inguinal hernia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tep surgery for inguinal hernia | Procedure | TEP surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores (0-100) after surgery | Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome | from day 1 to 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of operative complications | Any minor or major complication | from day 1 to 1 month postoperatively |
| Number of re-operations | Any re-operation |
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Inclusion Criteria:
Clinical diagnosis of symptomatic inguinal hernia Age 18-80
Exclusion Criteria:
Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3
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| Name | Affiliation | Role |
|---|---|---|
| Hannu Paajanen, Prof | Kuopio University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Kuopio | 70600 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34791044 | Derived | Matikainen M, Vironen JH, Silvasti S, Ilves I, Kossi J, Kivivuori A, Paajanen H. A randomized clinical trial comparing early patient-reported pain after open anterior mesh repair versus totally extraperitoneal repair of inguinal hernia. Br J Surg. 2021 Dec 1;108(12):1433-1437. doi: 10.1093/bjs/znab354. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
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| Lichtenstein |
| Procedure |
Lichtenstein surgery for inguinal hernia |
|
| 1 month after the operation |