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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.
ClinicalTrials.gov, NCT02743442

Sites

  • Fondation Ophtalmologique Adolphe de RothschildParis, France