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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transoral surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci® Si™ | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Surgery | Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure | 3 hours |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondation Ophtalmologique Adolphe de Rothschild | Paris | 75019 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transoral Surgery | da Vinci® Si™ single arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients were included between 2016 and 2018. The median age was 48 (minimum: 22 years, maximum: 69 years).
The median follow-up (time between the inclusion date and the end of the follow-up) was 6 months and 10 days.
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| ID | Title | Description |
|---|---|---|
| BG000 | Transoral Surgery | The study is a single arm : all patients were treated with da Vinci surgical procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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). | Posted | Number | participants | 1 day |
|
|
6 months
Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates.
Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transoral Surgery | Surgery of the pituitary adenoma via a transoral approach assisted by the da Vinci® Si™ robot |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complication of neurological intervention | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment | Rhinorrhea with cerebrospinal fluid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes insipidus | Endocrine disorders | MedDRA (19.0) | Systematic Assessment | polyuro-polydipsic syndrome |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Amélie Yavchitz (deputy head of the clinical research unit) | Fondation Ophtalmologique A. de Rothschild | +33148036454 | ayavchitz@for.paris |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2019 | Mar 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| 6 months |
| Duration of Hospitalization | Duration of hospitalization after surgery | 1 month |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Size of the lesion before surgery | Mean | Standard Deviation | millimeters |
|
| Participants |
|
|
| Secondary | Duration of Surgery | Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure | Not Posted | 3 hours | Participants |
| 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. | Not Posted | 6 months | Participants |
| Secondary | Duration of Hospitalization | Duration of hospitalization after surgery | Not Posted | 1 month | Participants |
| 0 |
| 8 |
| 4 |
| 8 |
| 7 |
| 8 |
|
| Injury, poisoning and complications of interventions | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment | Resumption of surgery |
|
| Injuries and complications related to an intervention | Cardiac disorders | MedDRA (19.0) | Systematic Assessment | Acute coronary syndrome during anesthesia (surgery of excision of the adenoma canceled) |
|
| Stroke | Vascular disorders | MedDRA (19.0) | Systematic Assessment | Stroke post surgical revision |
|
|
| Headaches | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nausea/vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Laryngeal pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Visual trouble | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fever | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Post-lumbar puncture syndrome | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pneumocephalus | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Corticotropin deficiency | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Paralysis of the nerve III | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pain at the incision site | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
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| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |