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This randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolene Hernia System device | Experimental | Inguinal hernia repair either with a bilayer mesh (PHS) |
|
| Lichtenstein | Experimental | Inguinal hernia repair with the Lichtenstein technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open mesh inguinal hernia repair | Procedure | Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Sequelae | Any pain at five years | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Espoo | 07430 | Finland |
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Included were 300 adult patients (282 men, 18 women) referred for elective repair having unilateral or bilateral inguinal hernias. Study period: September 2001 - January 2004, outpatient unit of Jorvi Hospital (Helsinki University Central Hospital, Espoo, Finland).
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| ID | Title | Description |
|---|---|---|
| FG000 | Prolene Hernia System Device | Inguinal hernia repair either with a bilayer mesh (PHS) |
| FG001 | Lichtenstein | Inguinal hernia repair with the Lichtenstein technique |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prolene Hernia System Device | Inguinal hernia repair either with a bilayer mesh (PHS) |
| BG001 | Lichtenstein | Inguinal hernia repair with the Lichtenstein technique |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Long-term Sequelae | Any pain at five years | Posted | Number | percentage of participants | 5 years |
|
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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 | Prolene Hernia System Device | Inguinal hernia repair either with a bilayer mesh (PHS) Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique Prolene Hernia System: Prolene Hernia System |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Georgios Pierides | Helsinki University Central Hospital | +358 9 4711 | georgios.pierides@hus.fi |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D006552 | Hernia, Inguinal |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Prolene Hernia System | Device | Prolene Hernia System |
|
| Lichtenstein technique | Procedure | Lichtenstein technique |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | Lichtenstein | Inguinal hernia repair with the Lichtenstein technique Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique Lichtenstein technique: Lichtenstein technique | 0 | 149 | 0 | 149 |
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| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |