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| Name | Class |
|---|---|
| Duke University | OTHER |
| Providence Medical Research Center | OTHER |
| University of South Florida | OTHER |
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The purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Covidien Radial Reload Stapler with Tri-Staple Technology | Experimental | Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covidien Radial Reload Stapler with Tri-Staple Technology | Device | Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler |
| Measure | Description | Time Frame |
|---|---|---|
| Staple Line | The surgeons ability to achieve a staple line at the desired level of the rectum. | Operative |
| Distal Margins | The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum. | Operative |
| Measure | Description | Time Frame |
|---|---|---|
| Usability: Visibility | Visibility measured by surgeon usability questionnaire. | Operatively |
| Usability: Access | Access measured by surgeon usability questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33606 | United States | ||
| Duke University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Covidien Radial Reload Stapler With Tri-Staple Technology | Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Covidien Radial Reload Stapler With Tri-Staple Technology | Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy |
| 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 | Staple Line | The surgeons ability to achieve a staple line at the desired level of the rectum. | Posted | Number | participants | Operative |
|
|
Adverse events were collected through the 30 day follow-up visit
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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 | Covidien Radial Reload Stapler With Tri-Staple Technology | Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary retention | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Doyle | Covidien | 781-839-1729 | Julie.Doyle@Covidien.com |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Operatively |
| Usability: Manueverability | Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate | Operatively |
| Durham |
| North Carolina |
| 27705 |
| United States |
| Providence Medical Center | Spokane | Washington | 99204 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
|
| Primary | Distal Margins | The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum. | Posted | Number | participants | Operative |
|
|
|
| Secondary | Usability: Visibility | Visibility measured by surgeon usability questionnaire. | Posted | Number | % of cases surgeon agree/strongly agree | Operatively |
|
|
|
| Secondary | Usability: Access | Access measured by surgeon usability questionnaire | Posted | Number | % of cases surgeon agree/strongly agree | Operatively |
|
|
|
| Secondary | Usability: Manueverability | Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate | Posted | Number | % of cases surgeon agree/strongly agree | Operatively |
|
|
|
| 4 |
| 8 |
| 2 |
| 8 |
| Pelvic abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Post-operative ileus | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
|
| Was rectum contained in the device after clamping |
|
| RR retained an adequate tissue during clamping |
|
| Was the rectum transected in one firing |
|