Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol. An Equivalence Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 630
- 主要终点
- Adenoma detection rate
研究概览
简要总结
The Efficacy and safety of Non-anesthesiologist administered propofol (NAAP) for gastrointestinal endoscopy have been widely documented although there is not information which has evaluated the outcomes of colonoscopy it self when the endoscopist has to fulfill the additional task of supervising the sedation.
Objective: To determine the equivalence of adenoma detection rate (ADR) in colorectal cancer (CRC) screening colonoscopies performed with NAAP and performed with monitored anesthesia care (MAC).
Method: Single blind non-randomized controlled equivalence trial. Patients: Adults between 50 - 69 years old from National CRC screening program (CRCSP). Intervention: The patients are blindly assigned to undergo either colonoscopy with NAAP or MAC according to the arrival of fecal occult blood test, patient's suitability for colonoscopy date and availability of places at endoscopy schedule (with NAAP or MAC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients -
排除标准
- •Patients with familial colorectal cancer history
结局指标
主要结局
Adenoma detection rate
时间窗: 30 days
Percentage of patients aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed
次要结局
未报告次要终点
研究者
Marco Alburquerque
Head of Gastroenterology Department
Serveis de Salut Integrats Baix Empordà