Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Patients Operated Via da Vinci Robot
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Insufficient buccal opening
- •Intercurrent pathology of oropharyngeal and nasopharyngeal
- •Complicated forms of adenoma pituitary adenoma (invasive adenoma)
- •Hemostasis disorder
- •Phlebitis or active pulmonary embolism
结局指标
主要结局
Number of Patients Operated Via da Vinci Robot
时间窗: 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
次要结局
- Duration of Hospitalization(1 month)
- Number of Severe Adverse Events(6 months)
- Duration of Surgery(3 hours)