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To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Permacol Patients | Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Permacol Surgical Implant | Device | Permacol Surgical Implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Hernia Recurrence | Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Unconfirmed Hernia or Hernia Recurrence | Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage) Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone surgical repair of their abdominal wall defects with Permacol Surgical Implants with at least 12 months(-30days)follow-up
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Annie Choi | Bedford | Massachusetts | 01730 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24508570 | Derived | Chand B, Indeck M, Needleman B, Finnegan M, Van Sickle KR, Ystgaard B, Gossetti F, Pullan RD, Giordano P, McKinley A. A retrospective study evaluating the use of Permacol surgical implant in incisional and ventral hernia repair. Int J Surg. 2014;12(4):296-303. doi: 10.1016/j.ijsu.2014.01.025. Epub 2014 Feb 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Permacol Patients | Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Permacol Patients | Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Confirmed Hernia Recurrence | Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review | Posted | Number | participants | 12 months |
|
|
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There were no AEs collected for this study.
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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 | Permacol Patients | Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annie Choi | Covidien | 781-839-1756 | annie.choi@covidien.com |
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| Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed | Year 2 to Year 8 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Total Unconfirmed Hernia or Hernia Recurrence | Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage) Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review | Posted | Number | participants | 12 Months |
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|
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| Secondary | Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed | Posted | Number | participants | Year 2 to Year 8 |
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| 0 |
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| Title |
|---|
| Measurements |
|---|
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| Year 5- out of 25 pts |
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| Year 6- out of 13 pts |
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| Year 7- out of 6 pts |
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| Year 8- out of 2 pts |
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