Colonoscopy Using Motorized Spiral Enteroscope: Prospective Bi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- evaluate the feasibility of motorized PowerSpiral enteroscopy for difficult colonoscopies
研究概览
简要总结
The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy.
详细描述
Cecal intubation rate represents a key procedural quality parameter in diagnostic colonoscopy. However, even in experienced hands, a significant percentage of colonoscopies (1.6-16.7%) remain incomplete because of a failure to intubate the cecum. The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy. The study aim was to evaluate the feasibility and safety of motorized Spiral enteroscopy for difficult colonoscopies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Indications for Spiral colonoscopy as a rescue procedure because of incomplete antecedent colonoscopy
排除标准
- •Age under 18 years
- •Known pregnancy
- •Poor health status (ASA classification ≥ 4)
- •Contraindication for sedation or standard colonoscopy
- •Known coagulopathy (INR ≥ 2.0, platelets < 70 /nl) or anticoagulants other than aspirin
- •Medical history of chronic inflammatory bowel disease or suspected bowel obstruction
结局指标
主要结局
evaluate the feasibility of motorized PowerSpiral enteroscopy for difficult colonoscopies
时间窗: during procedure
achieving cecum intubation in difficult colons
evaluate the safety of motorized PowerSpiral enteroscopy for difficult colonoscopies
时间窗: 7 days
Registering adverse events
次要结局
- Endoscopic mucosal resection(during procedure)
研究者
Abdulbaqi Al-Toma
Principal investigator
St. Antonius Hospital