Clinical Trial: Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title:
Brief 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.
Detailed Summary:
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Current Primary Outcome: Number of patients in which the entire sella turcica (including its anterior face) is seen during surgery and reached by the robotic arms. [ Time Frame: 1 day ]
Original Primary Outcome: Number of patients in which the entire sella turcica (including its anterior face) is seen during surgery and reached by the robotic arms. [ Time Frame: End of surgery ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Fondation Ophtalmologique Adolphe de Rothschild
Dates:
Date Received: April 4, 2016
Date Started: March 2016
Date Completion:
Last Updated: August 9, 2016
Last Verified: August 2016
