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Slow recruitment
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| Name | Class |
|---|---|
| University Hospitals Cleveland Medical Center | OTHER |
| Duke University | OTHER |
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To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.
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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 laparoscopic LAR or proctosigmoidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covidien Radial Reload Stapler with Tri-Staple Technology | Device | Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met | The surgeon's ability to achieve a staple line at the desired level of the rectum. | Operative |
| The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met | 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 |
|---|---|---|
| Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | 1. Access measured by surgeon usability questionnaire. | Operatively |
| Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Conor Delaney, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
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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 laparoscopic low anterior resection or 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 laparoscopic low anterior resection or 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 | The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met | The surgeon's 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 laparoscopic low anterior resection or 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 tract infection | Infections and infestations | 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 |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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2. Visibility measured by surgeon usability questionnaire |
| Operatively |
| Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | 3. Maneuverability measured by surgeon usability questionnaire Question: Maneuverability of Radial reload during the procedure was adequate | Operatively |
| 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 | The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met | 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 | Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | 1. Access measured by surgeon usability questionnaire. | Posted | Number | % of cases surgeon agree/strongly agree | Operatively |
|
|
|
| Secondary | Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | 2. Visibility measured by surgeon usability questionnaire | Posted | Number | % of cases surgeon agree/strongly agree | Operatively |
|
|
|
| Secondary | Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree | 3. Maneuverability 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 |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Interoperative bleeding | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Title | Measurements |
|---|
|
| Was the rectum contained in device after clamping |
|
| RR retained an adequate amount of tissue |
|
| Was the rectum transected with one firing |
|