A Validation Study of the 3D-CoPS and 3D-CoRS and Its Relationship With an International Acknowledged Assessment Tool (ETS) in Simulated Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 3D-Colonoscopy Retraction Score
研究概览
简要总结
A cross validation study comparing an international acknowledged assessment tool "Endoscopy Training System" (ETS) and movement analysis of the colonoscope based on raw data from coils within the scope.
24 physicians are recruited and divided based on experience (novices and experienced). All participants are to perform twice on the ETS that is based on four tasks; Scope manipulation, tool targeting, loop management and mucosal inspection. The movement of the colonoscope will be gathered during the tasks and correlated to the scores of the ETS.
详细描述
24 physicians are recruited on a voluntarily basis, and will be divided into two groups, based on experience;
- 12 Novices (0-50 colonoscopies)
- 12 Experienced (> 140 colonoscopies). The groups are to perform twice on the Endoscopy Training System that is based on four tasks; Scope manipulation, tool targeting, loop management and mucosal inspection. Data for 3D-Colonoscopy Retraction Score (3D-CoRS) will be gathered during the task of mucosal inspection and data for 3D-Colonoscopy Progression Score (3D-CoPS) are collected during loop management.
Novice group:
Any physician who has no experience of endoscopies or has done no more than 50 colonoscopies.
Experienced group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
This is a vialidation study of a computerized analysis of the colonoscope movements during a simulated procedure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physicians
排除标准
- •Non physicians
研究组 & 干预措施
Novices
Any physician who has no experience of endoscopies or has done no more than 50 colonoscopies.
Each subject included are to perform on the Endoscopy Training System (ETS) during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.
干预措施: 3D-Colonoscopy Progression Score (Other)
Novices
Any physician who has no experience of endoscopies or has done no more than 50 colonoscopies.
Each subject included are to perform on the Endoscopy Training System (ETS) during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.
干预措施: Endoscopy Training System (Other)
Experienced
Includes any physician who have succeeded more than 140 colonoscopies. Professional backgrounds include surgeons and gastroenterologists.
Each subject included are to perform on the ETS during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.
干预措施: 3D-Colonoscopy Progression Score (Other)
Novices
Any physician who has no experience of endoscopies or has done no more than 50 colonoscopies.
Each subject included are to perform on the Endoscopy Training System (ETS) during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.
干预措施: 3D-Colonoscopy Retraction Score (Other)
Experienced
Includes any physician who have succeeded more than 140 colonoscopies. Professional backgrounds include surgeons and gastroenterologists.
Each subject included are to perform on the ETS during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.
干预措施: Endoscopy Training System (Other)
Experienced
Includes any physician who have succeeded more than 140 colonoscopies. Professional backgrounds include surgeons and gastroenterologists.
Each subject included are to perform on the ETS during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.
干预措施: 3D-Colonoscopy Retraction Score (Other)
结局指标
主要结局
3D-Colonoscopy Retraction Score
时间窗: 3 months
The score is based on a movement analysis of the colonoscope from cecum to the anus. It is scaled from 0-1000. A score of zero equals a very poor score, Increasing score represents better technical performance with a maximum score of 1000.
3D-Colonoscopy Progression Score
时间窗: 3 months
The score is based on a movement analysis of the colonoscope from anus until max insertion(cecum). It is scaled from 0-1000 .A score of zero equals an incomplete procedure and a score of 1 is a very poor score but the cecum was reached. Increasing score represents better technical performance with a maximum score of 1000.
次要结局
- Relationship to other variables(3 months)
研究者
Andreas Slot Vilmann
MD. Andreas Slot Vilmann
Rigshospitalet, Denmark