Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- To see if robotic surgery is technically feasible for patients with inflammatory bowel disease measured during intra-operative procedure that includes: estimated blood loss in mL.
研究概览
简要总结
To determine if robotic surgery can be performed for inflammatory bowel disease (IBD) patients, to ascertain the optimal robotic set up for multi-quadrant IBD operations and evaluate clinical outcomes in robotic compared to laparoscopic surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or over
- •Undergoing IBD surgery using MIS (minimally invasive surgery) techniques
- •Histological/radiological evidence of inflammatory bowel disease
排除标准
- •Planned open surgical approach
- •Lacks capacity to provide informed consent
结局指标
主要结局
To see if robotic surgery is technically feasible for patients with inflammatory bowel disease measured during intra-operative procedure that includes: estimated blood loss in mL.
时间窗: 12 months
Port placement using position of ports on the abdomen marked in a diagram during surgical procedure.
时间窗: 12 months
Docking of robotic arm in robotic surgery using number of times the docking was done with start and end docking time in HH:MM.
时间窗: 12 months
Operative time using time of surgery performed in HH:MM.
时间窗: 12 months
次要结局
未报告次要终点