NCT01059357已完成不适用
A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
研究概览
简要总结
The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
详细描述
Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).
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
- •Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
- •Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
排除标准
- •Unexplained fever and/or untreated, active infection
- •Patient pregnancy
- •Previous head and neck surgery precluding transoral/robotic procedures
- •The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
研究组 & 干预措施
Transoral Robotic Surgery (TORS)
Experimental
Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System
干预措施: Da Vinci Robotic Transoral Robotic Surgical System (Device)
结局指标
主要结局
The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
时间窗: At time of surgery, lasting up to 3 hours. Assessed for up to 6 months
In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis
次要结局
- Operative Time(At time of surgery, up to 3 hours)
- Number of Participants With Blood Loss and Complications(6 months)
- Average Time to Set up and Perform Procedures(At time of surgery, up to 3 hours)
- Number of Correctly Predicted Success of TORS Preoperatively(preoperative)
- QOL(6 months)
研究者
研究点 (2)
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