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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03122 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery
To conduct a pilot single-arm study to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transoral robotic surgery (TORS) | Experimental | Patients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transoral robotic surgery | Procedure | Undergo TORS using the Da Vinci Robotic Surgical System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions. | up to eight years |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications. | If the planned procedure is a combined procedure, (robotic + non robotic) above mentioned measures are going to be presented separately for successful fully robotic surgeries and for unsuccessful mixed surgeries. 2. To identify the learning curve for TORS by measuring the efficiency and accuracy of the surgeons who perform the procedures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Contact | 1-800-293-5066 | OSUCCCClinicaltrials@osumc.edu | |
| Chelsea Marra | Contact | Chelseaanne.Marra@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Enver Ozer, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| Jamesline | View source |
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| quality of life assessment | Procedure | After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete. |
|
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| up to eight years |
| Assess the quality of life of the patients with TORS. | up to eight years |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D014062 | Tongue Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D009059 | Mouth Diseases |
| D014060 | Tongue Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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