NCT01257633已完成不适用
Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
Centre Hospitalier Universitaire de Nīmes3 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2011年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors
研究概览
简要总结
The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has signed consent
- •The subject must be a member or beneficiary of a health insurance plan
- •The patient is available for 12 months of follow-up
- •The subject has a cancer of the larynx:
- •classified T1 or T2 in the TNM
- •glottic localization and / or supraglottic regardless of node status
- •with or without a history of head and neck cancer
- •The subject does not have distant metastasis (M0)
- •A decision for endoscopic robot-assisted surgery is retained in multidisciplinary meeting
排除标准
- 未提供
结局指标
主要结局
The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors
时间窗: 1 day
次要结局
- Time to prepare the surgical setting (min)(1 day)
- Time necessary to dock the robot (min)(1 day)
- Total surgical time (console time) (min)(1 day)
- Intervention time taking into account cervical ganglions (min)(1 day)
- Was a tracheotomy necessary? yes/no(1 day)
- Presence / absence of bleeding complications(1 day)
- Was a conversion to an open procedure necessary? yes/no(1 day)
研究者
研究点 (3)
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