Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland (ROBOPHYSE)
Primary Purpose
Pituitary Neoplasms
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
da Vinci® Si™
Sponsored by
About this trial
This is an interventional treatment trial for Pituitary Neoplasms
Eligibility Criteria
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
Sites / Locations
- Fondation Ophtalmologique Adolphe de Rothschild
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transoral surgery
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration of Surgery
Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure
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.
Duration of Hospitalization
Duration of hospitalization after surgery
Full Information
NCT ID
NCT02743442
First Posted
April 4, 2016
Last Updated
March 3, 2021
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT02743442
Brief Title
Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland
Acronym
ROBOPHYSE
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Study Start Date
March 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transoral surgery
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
da Vinci® Si™
Primary Outcome Measure Information:
Title
Number of Patients Operated Via da Vinci Robot
Description
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
Secondary Outcome Measure Information:
Title
Duration of Surgery
Description
Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure
Time Frame
3 hours
Title
Number of Severe Adverse Events
Description
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.
Time Frame
6 months
Title
Duration of Hospitalization
Description
Duration of hospitalization after surgery
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland
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