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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-10968 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.
The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) being evaluated in this pilot study consists of 3 basic components: a surgeon's console, articulated mechanical arms and sterilizable instruments. The console includes a computer, video monitor and instrument controls, and is located in the operating room adjacent to the operating room table. The console is connected via computer to the mechanical arms holding the endoscope (surgical TV camera) and sterile surgical tools (e.g., forceps, scissors, electrocautery, etc.). These arms are located immediately adjacent to the patient on the operating room table. The surgeon sits at the console and controls the position and movement of the arms and surgical tools. The design of these tools is based upon well-established, commonly used surgical instruments. The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a "manual image-guided surgery" system that is computer enhanced rather than "computer guided robotic surgery" in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a "milling" device). Use of the da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in the aforementioned configuration in fact facilitates an exact translation of the surgeon's hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trans Oral Robotic Surgery (TORS) | Other | Patient's are having TORS surgery in a seated position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device | Device | Patient's will be having TORS surgery in a seated position |
|
| Measure | Description | Time Frame |
|---|---|---|
| TORS surgery completion in the seated position | Recording how many participants' surgery was completed in the seated position | Measures assessed at time of intervention (during surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of participants' surgical time | Surgical start and stop times are recorded in the medical record | Measures assessed at time of intervention (during surgery) |
| Estimated amount of blood loss during participants' surgery |
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Inclusion Criteria:
Pre-Operative Exclusion Criteria:
Intra-Operative Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Van Abel, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22386176 | Background | Moore EJ, Olsen SM, Laborde RR, Garcia JJ, Walsh FJ, Price DL, Janus JR, Kasperbauer JL, Olsen KD. Long-term functional and oncologic results of transoral robotic surgery for oropharyngeal squamous cell carcinoma. Mayo Clin Proc. 2012 Mar;87(3):219-25. doi: 10.1016/j.mayocp.2011.10.007. | |
| 22752997 | Background |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009371 | Neoplasms by Site |
| D010608 | Pharyngeal Diseases |
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|
Record blood loss during surgery as estimated by the lead surgeon
| Measures assessed at time of intervention (during surgery) |
| Weinstein GS, O'Malley BW Jr, Magnuson JS, Carroll WR, Olsen KD, Daio L, Moore EJ, Holsinger FC. Transoral robotic surgery: a multicenter study to assess feasibility, safety, and surgical margins. Laryngoscope. 2012 Aug;122(8):1701-7. doi: 10.1002/lary.23294. Epub 2012 Jul 2. |
| 4069324 | Background | Matjasko J, Petrozza P, Cohen M, Steinberg P. Anesthesia and surgery in the seated position: analysis of 554 cases. Neurosurgery. 1985 Nov;17(5):695-702. doi: 10.1227/00006123-198511000-00001. |
| 16464980 | Background | Engelhardt M, Folkers W, Brenke C, Scholz M, Harders A, Fidorra H, Schmieder K. Neurosurgical operations with the patient in sitting position: analysis of risk factors using transcranial Doppler sonography. Br J Anaesth. 2006 Apr;96(4):467-72. doi: 10.1093/bja/ael015. Epub 2006 Feb 7. |
| 22369328 | Background | Van Abel KM, Moore EJ. The rise of transoral robotic surgery in the head and neck: emerging applications. Expert Rev Anticancer Ther. 2012 Mar;12(3):373-80. doi: 10.1586/era.12.7. |
| 21344431 | Background | Moore EJ, Olsen KD, Martin EJ. Concurrent neck dissection and transoral robotic surgery. Laryngoscope. 2011 Mar;121(3):541-4. doi: 10.1002/lary.21435. Epub 2011 Jan 4. |
| 19342953 | Background | Weinstein GS, O'Malley BW Jr, Desai SC, Quon H. Transoral robotic surgery: does the ends justify the means? Curr Opin Otolaryngol Head Neck Surg. 2009 Apr;17(2):126-31. doi: 10.1097/MOO.0b013e32832924f5. |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |