Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland

Not Applicable

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Pituitary adenoma with a surgical indication : visual compression and chiasmal syndrome, intracranial hypertension , hormonal syndrome (hypopituitarism and hypersecretion ) , failure of medicamentous treatments for prolactinoma
No pituitary apoplexy (requiring emergency surgery)
Spontaneous oral opening greater than 35 mm

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Transoral surgery	da Vinci® Si™	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Operated Via da Vinci Robot	1 day	Number of patients in which the entire sella turcica (including its anterior face) is seen during surgery and reached by the robotic arms

Secondary Outcome Measures

Name	Time	Method
Duration of Hospitalization	1 month	Duration of hospitalization after surgery
Number of Severe Adverse Events	6 months	An adverse event occurring after the procedure is serious if it causes death, endangers the life of the person who is suitable for research, requires or prolongs hospitalization, causes a significant handicap, results in a congenital malformation, or is considered medically significant.
Duration of Surgery	3 hours	Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure