Clinical trial · Interventional
Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Neoplasms | Pituitary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| da Vinci® Si™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transoral surgery
- interventionNames
- Device: da Vinci® Si™
Primary outcomes (1)
- measure
- Number of Patients Operated Via da Vinci Robot
- timeFrame
- 1 day
- description
- Number of patients in which the entire sella turcica (including its anterior face) is seen during surgery and reached by the robotic arms
Secondary outcomes (3)
- measure
- Duration of Surgery
- timeFrame
- 3 hours
- description
- Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available