Ultrafine Endoscope for Unsedated Colonoscopy is an Effective Method to Reduce Abdominal Pain:a Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VAS abdominal pain scores
研究概览
简要总结
This study is the evaluation of ultrafine endoscope (with small caliber and turning radius )for colonoscopy in decreasing abdominal pain of patients . 60 patients will be accepted in this trial.
详细描述
The aim of this study is to investigate the advantages of an endoscope with smaller turning radius and softer insert section in reducing patients' abdominal pain in colonoscopy. Transnasal gastroscope was selected in this study , because of its small caliber (5.9mm) and small turning radius . Visual analogue scale(VAS),cecum intubation time and cecum intubation rate were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Patients diagnostic colonoscopy;
- •Subjects able to provide informed consent
排除标准
- •Patients with poor bowel preparation;
- •Contraindications of the colonoscopy;
- •Prior partial or complete colectomy
结局指标
主要结局
VAS abdominal pain scores
时间窗: up to two months
VAS abdominal pain scores include pain scores in the insertion phase of splenic flexure,hepatic flexure,and ileocecal junction.(0=no pain and 10=most severe pain imaginable).
次要结局
- Cecum intubation time(up to two months)
- The time to reach the splenic flexure(up to two months)
- The time to reach the hepatic flexure(up to two months)
- The success rate of the cecal intubation within 15 minutes(up to two months)
研究者
Youlin Yang ,MD
Professor
First Affiliated Hospital of Harbin Medical University