TriangleNCT02743442 · REGISTRY CONDITION SEARCH
Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- TERMINATED
- Registry last update
- 2021-03-29
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Device: da Vinci® Si™
- label
- Transoral surgery
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Transoral surgery
- name
- da Vinci® Si™
- type
- DEVICE
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 8
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Number of patients in which the entire sella turcica (including its anterior face) is seen during surgery and reached by the robotic arms
- measure
- Number of Patients Operated Via da Vinci Robot
- time Frame
- 1 day
- secondary Outcomes
- description
- Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure
- measure
- Duration of Surgery
- time Frame
- 3 hours
- 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.
- measure
- Number of Severe Adverse Events
- time Frame
- 6 months
- description
- Duration of hospitalization after surgery
- measure
- Duration of Hospitalization
- time Frame
- 1 month
Full 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.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-7ab42c20a361178c2622
- requested nct id
- NCT02743442
- primary nct id
- NCT02743442
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- 3ef78ce4ecba793eb2b9932bd51babe9d6d7cee15aba0d82d9e98002353b720a
- payload sha256
- a50193ac319bae03b7bcfb64a115bc796cc93ce3509907b0b9424a6b20e5a3af
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-7ab42c20a361178c2622
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT02743442
- occurrences
- context exact
- NCT02743442
- end
- 11
- exact text
- NCT02743442
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Pituitary Tumors
- query disease state id
- ds-pituitary-tumors
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-pituitary-tumors-000.json
- source file sha256
- 3ef78ce4ecba793eb2b9932bd51babe9d6d7cee15aba0d82d9e98002353b720a
- source json pointer
- /studies/34/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- e22b8d3bb2c260d0780fef0eb2c943c89c882c438b7c7d845dbaec7b9a5d1df0
Preserved source evidence · Not medical advice