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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU 60209 | Other Identifier | Wake Forest University Health Sciences |
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The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transoral Robotic Surgery (TORS) | Experimental | Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Da Vinci Robotic Transoral Robotic Surgical System | Device | (TORS) Da Vinci Robotic Transoral Robotic Surgical System |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis. | In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis | At time of surgery, lasting up to 3 hours. Assessed for up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation. | At time of surgery, up to 3 hours |
| Number of Participants With Blood Loss and Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua D. Waltonen, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transoral Robotic Surgery (TORS) | Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transoral Robotic Surgery (TORS) | Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System |
| 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 Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis. | In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis | Posted | Count of Participants | Participants | At time of surgery, lasting up to 3 hours. Assessed for up to 6 months |
|
|
up to 6 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 | Transoral Robotic Surgery (TORS) | Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joshua Waltonen | Wake Forest University Health Sciences | 3367169068 | jwaltone@wakehealth.edu |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 6 months |
| Average Time to Set up and Perform Procedures | This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures. | At time of surgery, up to 3 hours |
| Number of Correctly Predicted Success of TORS Preoperatively | This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures. | preoperative |
| QOL | Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome. | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Operative Time | The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation. | Posted | Mean | Standard Deviation | minutes | At time of surgery, up to 3 hours |
|
|
|
| Secondary | Number of Participants With Blood Loss and Complications | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Average Time to Set up and Perform Procedures | This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures. | Posted | Mean | Standard Deviation | minutes | At time of surgery, up to 3 hours |
|
|
|
| Secondary | Number of Correctly Predicted Success of TORS Preoperatively | This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures. | Posted | Number | procedures | preoperative |
|
|
|
| Secondary | QOL | Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome. | Data not collected on all participants | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 7 |
| 54 |
| Chipped tooth | General disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Postoperative bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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