Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland

Study Overview
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Brief Summary
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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
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Pituitary Neoplasms

Intervention / Treatment
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* Device: da Vinci® Si™


Participation Criteria
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Eligibility Criteria
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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: Insufficient buccal opening Intercurrent pathology of oropharyngeal and nasopharyngeal Complicated forms of adenoma pituitary adenoma (invasive adenoma) Hemostasis disorder Phlebitis or active pulmonary embolism

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transoral surgery<br> | Device: da Vinci® Si™<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Surgery | Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure | 3 hours | 
| Number of Severe Adverse Events | 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. | 6 months | 
| Duration of Hospitalization | Duration of hospitalization after surgery | 1 month |