Pituitary Neoplasms Clinical Trial
— ROBOPHYSENCT 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 |
Verified date | March 2021 |
Source | Fondation Ophtalmologique Adolphe de Rothschild |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Fondation Ophtalmologique Adolphe de Rothschild | Paris |
Lead Sponsor | Collaborator |
---|---|
Fondation Ophtalmologique Adolphe de Rothschild |
France,
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 |
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