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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02743442
Other study ID # DCT-2015-043
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date September 2018

Study information

Verified date March 2021
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 information / eligibility

Status Terminated
Enrollment 8
Est. completion date September 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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: - Insufficient buccal opening - Intercurrent pathology of oropharyngeal and nasopharyngeal - Complicated forms of adenoma pituitary adenoma (invasive adenoma) - Hemostasis disorder - Phlebitis or active pulmonary embolism

Study Design


Related Conditions & MeSH terms


Intervention

Device:
da Vinci® Si™


Locations

Country Name City State
France Fondation Ophtalmologique Adolphe de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Duration of Surgery Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure 3 hours
Secondary 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
Secondary Duration of Hospitalization Duration of hospitalization after surgery 1 month
See also
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