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5. Endpoints will be compared to historical controls.
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).22 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 |
|---|---|---|---|
| 1 | Experimental | robot assisted endoscopic head and neck surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System | Device | Planned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System |
| Measure | Description | Time Frame |
|---|---|---|
| ability to adequately visualize the operative field and complete planned surgery | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| complication rate compared to standard endoscopic and minimally invasive procedures | 1 month | |
| blood loss compared to historical controls of endoscopic and minimally invasive procedures | 1 day | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard V Smith, MD | Montefiore Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15167030 | Background | Gourin CG, Terris DJ. Surgical robotics in otolaryngology: expanding the technology envelope. Curr Opin Otolaryngol Head Neck Surg. 2004 Jun;12(3):204-8. doi: 10.1097/01.moo.0000122309.13359.af. | |
| 15933510 | Background | Hockstein NG, Nolan JP, O'Malley BW Jr, Woo YJ. Robot-assisted pharyngeal and laryngeal microsurgery: results of robotic cadaver dissections. Laryngoscope. 2005 Jun;115(6):1003-8. doi: 10.1212/01.WNL.0000164714.90354.7D. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2024 | |
| Reset | Mar 5, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2024 | Mar 5, 2024 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| quality of life at early (1-3 months) and late (one year) |
| 1 year |
| number of days hospitalized immediately after surgery | at discharge from hospital |
| Time to recurrence of tumor or other pathology for which procedure was performed | at recurrence of tumor or pathology |
| Time from start of treatment to death | at time of death |
| 16467698 | Background | Hockstein NG, O'Malley BW Jr, Weinstein GS. Assessment of intraoperative safety in transoral robotic surgery. Laryngoscope. 2006 Feb;116(2):165-8. doi: 10.1097/01.mlg.0000199899.00479.75. |
| 16366877 | Background | Lobe TE, Wright SK, Irish MS. Novel uses of surgical robotics in head and neck surgery. J Laparoendosc Adv Surg Tech A. 2005 Dec;15(6):647-52. doi: 10.1089/lap.2005.15.647. |
| 17011430 | Background | Tanna N, Joshi AS, Glade RS, Zalkind D, Sadeghi N. Da Vinci robot-assisted endocrine surgery: novel applications in otolaryngology. Otolaryngol Head Neck Surg. 2006 Oct;135(4):633-5. doi: 10.1016/j.otohns.2006.07.003. No abstract available. |