NCT02743442

Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pituitary Neoplasms

Interventions

Type	Name	Description
DEVICE	da Vinci® Si™

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-03-01
• Completion: 2018-09-01
• First posted: 2016-04-19
• Last updated: 2021-03-29
• Results posted: 2021-03-29

Locations

1 site across 1 country: France