Pituitary Neoplasms
Conditions
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.
Interventions
DEVICEda Vinci® Si™
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Surgery | 3 hours | Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure |
| 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 Hospitalization | 1 month | Duration of hospitalization after surgery |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transoral Surgery The study is a single arm : all patients were treated with da Vinci surgical procedure. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Transoral Surgery |
|---|---|
| Age, Continuous | 46.25 years STANDARD_DEVIATION 15.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment France | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
| Size of the lesion before surgery | 30.75 millimeters STANDARD_DEVIATION 6.14 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 7 / 8 |
| serious Total, serious adverse events | 4 / 8 |
Outcome results
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
Time frame: 1 day
Population: Among the 8 patients enrolled in this study, 7 were operated using the Vinci robot. The surgery was canceled for one patient with acute coronary syndrome (a serious adverse event not related to the study).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transoral Surgery | Number of Patients Operated Via da Vinci Robot | 7 participants |
Secondary
Duration of Hospitalization
Duration of hospitalization after surgery
Time frame: 1 month
Secondary
Duration of Surgery
Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure
Time frame: 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.
Time frame: 6 months