Stopped early
Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland
NCT02743442 · Fondation Ophtalmologique Adolphe de Rothschild · Updated 29 March 2021
- What is being tested
- da Vinci® Si™
- For
- Pituitary Neoplasms
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 8 people. The full rules are on the registry page.
- Where
- France
- When
- Starts or started March 2016, ends Sept 2018. Registered 19 April 2016.
- Results
- Posted on the registry on 29 March 2021.
In the researchers' words
Over the past 30 years, endoscopic transnasal techniques have gained a major interest, and anatomic limits have been widened in order to extend neurosurgical applications. For many years, robotic-assisted surgery using the da Vinci system (Intuitive Surgical Inc, Sunnyvale, California, USA) has been greatly developed, especially in urology and gynecology. Robotic-assisted surgery has been performed for pharyngeal and laryngeal cancers in a minimally invasive perspective. A robot-assisted preliminary series demonstrated the ability to approach the sella via oral approach without traumatic injury of nasal or oral cavity. Transoral approach avoids the complications of the endonasal resection: synechia, rhinitis sicca anterior, primary and secondary atrophican rhinitis, and empty nose syndrome. The investigators recently published a cadaveric study of transoral robotic-assisted skull base surgery to approach the sella turcica (Neurosurgical Rev. 2014; 37:609-17). In this study, the investigators will propose a new minimally invasive technique of pituitary surgery by transoral approach assisted by the da Vinci robot in patients with pituitary adenoma.
Sites
- Fondation Ophtalmologique Adolphe de RothschildParis, France
