NCT05652361招募中不适用
Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system
研究概览
简要总结
The aim of the study is to evaluate the technical feasibility and applicability of a surgical assistance system based on image recognition algorithms in a first-in-human pilot study. In addition, this study will provide preliminary data on the oncological outcome of the assistance system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with rectal cancer scheduled for robot-assisted rectal resection
- •Intact preoperative urogenital/rectal function
- •Full capability of consent
排除标准
- •Previous/Second malignant disease <5 years before diagnosis of rectal cancer
- •Previous abdominal surgery, except for laparoscopic appendectomy, laparoscopic cholecystectomy or Cesarean section
- •Pregnant or breastfeeding women
- •Addiction or illness that prevent the person concerned from assessing the nature and scope of the clinical trial and its possible consequences
- •indication that the participant is unlikely to comply with the trial protocoll (e.g. lack of compliance)
- •official or court order for involuntary hospitalization
研究组 & 干预措施
Additional visualisation of surgical assistance during surgery
Experimental
干预措施: Additional visualisation of surgical assistance during surgery (Other)
结局指标
主要结局
Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system
时间窗: 72 hours after Surgery
System discrepancy score quantifying major misspecifications of the CoBot system in comparison to the surgeon's action
次要结局
- Operating time [min](During Surgery)
- Assessment of the difficulty of the preparation(48 hours after surgery)
- Duration of postoperative hospital stay [days](At day of discharge, assessed up to 5 days)
- Duration of postoperative intermediate/intensive care unit stay [days](At day of discharge, assessed up to 5 days)
- Frequency of peri-operative morbidity after resection(At day of discharge, assessed of up to 5 days)
- Kind of peri-operative morbidity after resection(At day of discharge, assessed of up to 5 days)
- Assessment of the circumferential resection margin (CRM)(At day of discharge, assessed up to 5 days)
- Number of resected lymphnodes(During surgery)
- Assessment of pelvic function before and after rectal resection(15 months)
- Rectal sphincter function before and after rectal resection(15 months)
- Assessment of usability of guidance system(Through study completion, an average of 6 months)
研究者
研究点 (1)
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