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The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OM group | Active Comparator | Optilene LP mesh |
|
| UM group | Active Comparator | Ultrapro mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optilene LP mesh | Device | Lichtenstein hernioplasty |
| |
| Ultrapro mesh |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Pain | On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise | 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Pain | On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise | 3-year follow-up |
| Foreign Body Feeling | The question about foreign body feeling was a yes-or-no question |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | OM Group | Optilene LP mesh Optilene LP mesh: Lichtenstein hernioplasty |
| FG001 | UM Group | Ultrapro mesh Ultrapro mesh: Lichtenstein hernioplasty |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OM Group | Optilene LP mesh Optilene LP mesh: Lichtenstein hernioplasty |
| BG001 | UM Group | Ultrapro mesh Ultrapro mesh: Lichtenstein hernioplasty |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | >=18 years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Chronic Pain | On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise | Posted | Number | percentage of patients with pain | 6-month follow-up |
|
|
3-year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OM Group | Optilene LP mesh Optilene LP mesh: Lichtenstein hernioplasty | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ceith Nikkolo | Tartu University Hospital | +37253319082 | ceith.nikkolo@kliinikum.ee |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Device |
Lichtenstein hernioplasty |
|
| 6-month follow-up |
| Death |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Gender (male + female) | Number | participants |
|
| Unilateral inguinal hernia | Number | participants |
|
| Primary inguinal hernia | Number | participants |
|
| Reducible inguinal hernia | Number | participants |
|
| Elective operation | Number | participants |
|
| Participants |
|
|
| Secondary | Chronic Pain | On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise | Posted | Number | percentage of patients with pain | 3-year follow-up |
|
|
|
| Secondary | Foreign Body Feeling | The question about foreign body feeling was a yes-or-no question | Drop-outs at 6-month follow-up (3+6) not included | Posted | Number | percentage of patients with foreign body | 6-month follow-up |
|
|
|
| 63 |
| 0 |
| 63 |
| 10 |
| 63 |
| EG001 | UM Group | Ultrapro mesh Ultrapro mesh: Lichtenstein hernioplasty | 0 | 65 | 0 | 65 | 10 | 65 |
| Haematoma | Surgical and medical procedures | Systematic Assessment |
|
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |