A Prospective Comparative Study to Improve Preoperative Ultrasound Diagnosis of Rectal Fistulas in the Formation of Topical Diagnosis Using B-mode and Three-dimensional Image Reconstruction.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Sensitivity
研究概览
简要总结
Prospective comparative parallel ultrasound diagnostic transrectal study in the diagnosis of cryptogenic fistulas of the rectum
详细描述
It is planned to investigate 150 patients with cryptogenic fistulas. Patients will be divided into two groups: complete and incomplete internal fistulas of the rectum. Patients of the first group will undergo preoperative examination in the framework of transrectal ultrasound in B-mode, three-dimensional reconstruction of the image with a contrast of the fistula course with a solution of 1.5% hydrogen peroxide. Patients with incomplete internal fistulas of the rectum will also undergo transrectal ultrasound examination in B-mode and with three-dimensional image reconstruction. The results obtained in the two groups will be compared with the intraoperative revision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Patients diagnosed with "fistula of the rectum"
- •Patients diagnosed with cryptogenic fistulas
- •Patients who have signed informed consent
排除标准
- •Patients with perianal complications of Crohn's disease
- •Рatients with post-traumatic fistulas
- •Рatients with fistulas, drain pararectal cysts
- •Рatients with anal fissures, complicated by rectal fistula
- •Рatients who refused to participate in the study of their own free will
结局指标
主要结局
Sensitivity
时间窗: 14 days
Sensitivity in the diagnosis of cryptogenic fistulas of the rectum
次要结局
未报告次要终点