Targeted Abdominal Lymph nodE Dissections Randomized for Surgical NavigaTion (TALENT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Number of failed procedures
研究概览
简要总结
Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. In this study we will randomize patients which will undergo an abdominal lymph node dissection in order to evaluate the actual technical and clinical benefit of navigation
详细描述
In the study patients will be randomized between the use of a surgical navigation system or not. The operation itself will be performed according to current clinical practice, and the navigation system will be used for better localization and orientation during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan
排除标准
- •Metal implants in the pelvic area
- •Contra-indication for contrast enhanced CT scanning
结局指标
主要结局
Number of failed procedures
时间窗: 3 months
Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging
次要结局
- Surgical time to remove lymph node(After surgery)
- LN success(3 months)