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This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | lightweight polypropylene mesh |
|
| 2 | Active Comparator | Strattice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inguinal hernia repair with Ultrapro | Device | surgical mesh (15x15cm) to support Lichtenstein repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Activities Assessment Scale at 3 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty = 1" to "Not able to do it = 5." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. | Baseline to 3 Months |
| Change From Baseline in Activities Assessment Scale at 6 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. | Baseline to 6 Months |
| Change From Baseline in Activities Assessment Scale at 12 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Bellows, MD, FACS | Tulane University | Principal Investigator |
| Samir Awad, MD, FACS | Baylor College of Medicine | Principal Investigator |
| Robert Fitzgibbons, MD, FACS | Creighton University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of St Raphael | New Haven | Connecticut | 06511 | United States | ||
| Tulane University Health Sciences Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21222008 | Derived | Bellows CF, Shadduck PP, Helton WS, Fitzgibbons RJ. The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair. Hernia. 2011 Jun;15(3):325-32. doi: 10.1007/s10029-010-0773-x. Epub 2011 Jan 8. |
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First subject was enrolled on April 11, 2008 and last subject was enrolled on February 12, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r | lightweight polypropylene mesh |
| FG001 | 2Strattice (Utilized for Inguinal Hernia Repair) | Strattice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r | lightweight polypropylene mesh |
| BG001 | 2Strattice (Utilized for Inguinal Hernia Repair) | Strattice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Activities Assessment Scale at 3 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty = 1" to "Not able to do it = 5." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. | Of the 88 participants in Arm 1 who started the study, 81 completed the Activities Assessment Scale at 3 months. Of the 84 participants in Arm 2 who started the study, 77 completed the Activities Assessment Scale at 3 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3 Months |
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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 | 1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r | lightweight polypropylene mesh |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal Hernia | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal Hernia | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donna Jacobs | LifeCell | 908-809-7856 | djacobs@lifecell.com |
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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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| Inguinal hernia repair with Strattice | Device | Surgical mesh (10x16) used to support Lichtenstein repair |
|
|
| Baseline to 12 Months |
| Change From Baseline in Activities Assessment Scale at 24 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. | Baseline to 24 Months |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| Creighton University | Omaha | Nebraska | 68178 | United States |
| Regional Surgical Associates | Durham | North Carolina | 27704 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r | lightweight polypropylene mesh |
| OG001 | 2Strattice (Utilized for Inguinal Hernia Repair) | Strattice |
|
|
| Primary | Change From Baseline in Activities Assessment Scale at 6 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. | Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 6 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 6 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 Months |
|
|
|
| Primary | Change From Baseline in Activities Assessment Scale at 12 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. | Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 12 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 12 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 Months |
|
|
|
| Primary | Change From Baseline in Activities Assessment Scale at 24 Months | The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline. | Of the 88 participants in Arm 1 who started the study, 75 completed the Activities Assessment Scale at 24 months. Of the 84 participants in Arm 2 who started the study, 57 completed the Activities Assessment Scale at 24 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 24 Months |
|
|
|
| 2 |
| 88 |
| 47 |
| 88 |
| EG001 | 2Strattice (Utilized for Inguinal Hernia Repair) | Strattice | 4 | 84 | 49 | 84 |
| Local Swelling | General disorders |
|
| Incision Site Pain | Injury, poisoning and procedural complications |
|
| C-Reactive Protein Increased | Investigations |
|
| Groin Pain | Musculoskeletal and connective tissue disorders |
|
| Hypoaethesia | Nervous system disorders |
|
| Testicular Pain | Reproductive system and breast disorders |
|
Should Institution/PI/coPI/other staff want to publish information, data, or orally communicate,a complete copy of information/data will be provided to the Sponsor for review and comment at least 30 days prior to 1st submission. If Sponsor determines proposed publication/oral communication contains patentable or proprietary subject matter (requiring protection),Institution will delay for at least 90 days following the Sponsor's receipt of such copy for the purpose of filing patent applications.