NCT00918762已完成1 期
A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Operative time that directly affects operative cost
研究概览
简要总结
RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not yet known whether transoral robotic surgery is more effective than standard surgery in diagnosing and treating larynx and pharynx tumors.
PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared with standard surgery in treating patients with benign or malignant tumors of the larynx or pharynx.
详细描述
OBJECTIVES:
Primary
- Evaluate the potential benefits of using the transoral robotic surgical approach against the conventional open and transoral approaches in patients with benign or malignant disease involving the larynx and pharynx.
Secondary
- Determine the proportion of laryngeal and pharyngeal surgical procedures where the surgical exposure is adequate to allow the successful completion of the surgical resection using the transoral robotic surgical approach.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Operative time that directly affects operative cost
时间窗: post operative
次要结局
- Intra-operative and post-operative complications(during the operation and post operative)
- Margins status(post operative)
- Blood loss(During surgery)
- Length of hospital stay(during time as inpatient)
- Need for reconstruction(post operative)
- Tracheostomy and PEG dependence(post operative)
- Days to oral intake(post operative)
- Speech intelligibility(post operative)
- Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion(post operative)
- Time to locoregional recurrence(post operative)
- Quality of life(3 months and 6 month following completion of surgery)
- Postoperative pain(post operative)
研究者
Ho-Sheng Lin
Principal Investigator
Barbara Ann Karmanos Cancer Institute
研究点 (2)
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