Randomized Cross-Over Comparing Clinical Performance of Novice Trainee Endoscopists Using Conventional Air Insufflation Versus Warm Water Infusion Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- adenoma detection rate
研究概览
简要总结
Hypothesis: Novice trainees will achieve significantly higher clinical competence and patient satisfaction scores with the use of warm water infusion method when compared with traditional air insufflation
Primary outcome: adenoma detection rate
Secondary outcomes: (1) independent cecal intubation rate, (2) trainer assessment of trainee's colonoscopy skills, (3) trainee's assessment of clinical confidence, (4) procedural medication requirement, (5) patient pain level during procedure, (6) patient satisfaction at procedure completion, and (7) patient willingness to repeat procedure'
Specific Aim: To demonstrate the stated hypothesis via above outcome measures. The long term goal is to provide evidence to influence other training institutions to consider education in the warm water infusion method'
详细描述
Study Design: Prospective randomized cross-over study in a university based setting (University of California Davis, Sacramento, California) with a diverse patient population.
Participants: Total of 6 first year gastroenterology trainees (3 enrollees per year from July 2011 to July 2012)
Recruitment: Trainees' names and contact information will be acquired via the program director. They will be contacted in person on the first day of their fellowship orientation and provided information regarding the study.
Randomization: A sealed envelope containing the randomized method (conventional air insufflation or warm water infusion) will be opened at the time of signed consent for study participation.
Cross-over Design: Trainees will perform colonoscopies using the randomized method with a dedicated attending physician who uses air and/or water method as part of standard clinical practice for 6 months, at which point they will cross-over to the alternate method of colonoscopy with another dedicated attending for the remaining 6 months of their first year of fellowship.
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
- 是
入选标准
- •Novice endoscopists without prior colonoscopy experience
排除标准
- •Trainees who do not meet the basic prerequisites as stated above, or who are not willing to participate in the study
结局指标
主要结局
adenoma detection rate
时间窗: two years
次要结局
- independent cecal intubation rate(two years)