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| Name | Class |
|---|---|
| Synovis Surgical Innovations | INDUSTRY |
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Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.
Study is designed as a prospective enrollment of patients undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. Patients who are scheduled for elective resection of the left, anterior and low anterior colon can be enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | PSD Veritas Collagen Matrix Reinforcement Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staple line reinforcement | Device | Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. | Discharge and 1 Month post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Karulf, MD | Colon & Rectal Surgery Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States | ||
| Colon & Rectal Surgery Associates |
Subjects were excluded from the study if the met any of the exclusion criteria including having a a body mass index greater than 35, a history of Chron's Disease, or stage IV cancer. There was no washout, run-in or transition period to this study.
38 subjects were recruited from two principal investigators and their respective surgical hospitals in the US from approximately February 2007 through October 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | PSD Veritas Collagen Matrix Reinforcement Arm | Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PSD Veritas Collagen Matrix Reinforcement Arm | Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. |
| 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 | Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. | Posted | Number | Participants | Discharge and 1 Month post surgery |
|
|
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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 | PSD Veritas Collagen Matrix Reinforcement Arm | Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anastomotic Buttress Leak | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post operative ileus | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lesa Hobright-Turner, Director of Clinical Affairs | Synovis | 651-796-7506 | lesa.hobrightturner@synovissurgical.com |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Saint Paul |
| Minnesota |
| 55105 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 3 |
| 38 |
| 2 |
| 38 |
| Bleeding | Surgical and medical procedures | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |