Perianal Operating Scope Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Visual assessment of operative field dimensions measured in centimeters
研究概览
简要总结
This protocol will test a new prototype of a peri-anal access device, with increased flexible length and a captured operative field, for feasibility in patients immediately prior to their scheduled peri-anal procedure.
详细描述
Research Methods: The insertion of the modified access device in five patients before their planned peri-anal procedure, which will subsequently be performed with standard instruments, will allow us to observe the ease of insertion, the expansion of the blades, and the creation of the operative field achieved. If necessary, we will modify our design based on these findings. When a successful, operating room prototype is established, the device will be suitable for clinical use and the stated benefits thereof.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range 18 to 80
- •In good health status
- •Patients scheduled for a transanal procedure other than for anal lesions, e.g., hemorrhoids, fissures, abscesses
排除标准
- •Patients with physical characteristics that distort the rectal sigmoid anatomy, e.g., spinal lesions.
- •Patients considerable unsuitable for inclusion in the study by their colorectal surgeon.
- •Patients considered too frail or ill by their physician to undergo a 5-10 minute prolongation of their procedure.
- •Patients with known rectosigmoid infections.
- •Patients with known rectosigmoid wall fragility.
- •Patients with known rectosigmoid perforations.
结局指标
主要结局
Visual assessment of operative field dimensions measured in centimeters
时间窗: Baseline
The Outcome Measure Title implies the visual measurement that will be used to describe the potential operative field delineated by our experimental perianal access device. The description will, therefore, be primarily a qualitative visual assessment with the addition of estimated dimensions measured in centimeters for the length of the longitudinal and transverse fields encompassed by the blades of the access device. The collected measurement data will be aggregated, the numerical data averaged, and the visual perceptions integrated. The Time Frame for the individual study of each insertion will be two minutes or less. There is no chronic component to this feasibility analysis.
次要结局
未报告次要终点