Robot Based Tympanic Tube Placement
Keywords
Abstract
Description
Description of the population to be studied and justification of its choice:
This study is going to include a single group of patients presenting a vestibular schwannoma that will benefit from an removal by translabyrinthine approach with exclusion from the middle ear under general anesthesia. During this surgery, the tympanic membrane is systematically sacrificed and the inner ear opened with as consequence a complete loss of residual hearing and vertigo for a few days. In this protocol research, the patients will participate by accepting an robot based placement of a tympanic ventilation drain during the surgery before the sacrifice of the tympanic membrane.
All the patients will be adults, living in France, benefiting from the cover of the French health care system. The people participating to the research will have to give their consent to participate to the study.
Name and brief description of one or several experimental medical devices:
The concept of the device RobOtol® is based on a teleoperated system with 6 degrees of freedom.
The medical device is European Conformity (CE) marked since in June, 2016. The team of Ear, Nose and Throat (ENT) of Pitié-Salpêtrière (PSL) university hospital will lead this project.
Description and justification of the methods and the duration of study:
The studied device is a drain mounted on a trocar placed by means of the teleoperated system RobOtol.
The gold standard device and procedure is a drain inserted by the surgeon with forceps after incision of the eardrum.
The equipment RobOtol will be driven by the surgeon. The procedure will be conducted under general anesthesia.
Summarize of predictable and known benefits and risks for the people participating to the study:
There is no individual expected benefit considering the choice of the included population in the protocol. The population was chosen to eliminate the risks of unwanted effect during the installation of the drain by the robot (in particular the risks for the tympanic membrane).
The patients presenting an indication of tympanic ventilation drain placement (ex: serous otitis), have the exceptional risks, a hearing loss, a secondary infection of the drain or vertigo, or facial palsy.
The population chosen in this study has to benefit from a removal of a vestibular schwannoma. Within the procedure of this surgery, a total loss of the hearing, a sacrifice of the tympanic membrane and vertigo are expected and predictable consequences of the surgical technique. For that reason, there is no additional risk of complication.
The only risk is the fact that the general anesthesia will be prolonged for the study, for approximately 15 min on a surgery requiring an average duration of anesthesia of 5,5 hours (1 hour of perioperative anesthesia, 4,5 hours of surgery).
PROGRESS OF THE SEARCH
Modalities(Methods) of recruitment:
Fifteen adults presenting a vestibular schwannoma that will benefit from a removal by translabyrinthine approach with exclusion from the middle ear under general anesthesia will be included after information and obtaining of their written consent.
1. Visit of selection and inclusion The recruitment of the patients will be made from the line of the new patients by the investigators for the consultation of ENT of PSL.
Visit of selection / inclusion in the study by the ENT ( D0):
O Clinical examination: otoscopy, check of the diameter of the external auditory canal o Check of the criteria of inclusion and non inclusion o Information of the patient o Signature of the informed consent by the patient o Collection clinical data: sex, age, operated side (left / right), previous otological history, diameter of the external auditory canal
2. Visit of follow-up of the study
The intervention by the ENT (D14):
The intervention will take place in the operating room of the building Babinski and the service of ENT;
3. Visit of the end of the research There is no visit of post-operative follow-up nor visit of the end of planned research.
The patient sees his participation in the research ending after the removal of the tympanic membrane at D0.
Dates
| Last Verified: | 03/31/2019 |
| First Submitted: | 06/14/2018 |
| Estimated Enrollment Submitted: | 06/14/2018 |
| First Posted: | 06/25/2018 |
| Last Update Submitted: | 04/25/2019 |
| Last Update Posted: | 04/28/2019 |
| Actual Study Start Date: | 01/02/2019 |
| Estimated Primary Completion Date: | 12/31/2019 |
| Estimated Study Completion Date: | 02/27/2020 |
Condition or disease
Intervention/treatment
Device: Robotol
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Robotol | Device: Robotol Placement of a transtympanic drain with a robot based device assistance called RobOtol |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Patient candidate for exclusion of the middle ear when performing a translabyrinthine approach during a vestibular schwannoma surgery - Patient over 18 years old Exclusion Criteria: - Patient with psychomotor retardation or behavioral problems that preclude clinical examination - Patient with an external auditory canal diameter of less than 3 mm - Patient participating in another interventional clinical trial - Breastfeeding or pregnant woman - Patient not residing in France - Patient under tutorship / guardianship or under security measure - Patient who has not signed a written consent - Patient not benefiting from french national health insurance system |
Outcome
Primary Outcome Measures
1. Drain position on the tympanic membrane [one day]
Secondary Outcome Measures
1. The occurence of a bleeding intraoperative from the eardrum or from the external auditory canal [one day]
2. The occurence of a lesion of the tympanic membrane except the section necessary for the placement of the drain (tympanic perforation, accidental tear) [one day]
3. The number of contact between the cutaneous cover of the external auditory canal and the instrument of the robot [one day]
4. Duration of installation of the robot and the procedure [one day]
