Impact of Supine Position on Colonoscopy Insertion: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 1
- 主要终点
- cecal intubation time
研究概览
简要总结
The purpose of this study is to determine whether the supine position is better than the left lateral horizontal body position to decrease cecal intubation time, patients' pain and the difficulty of colonoscopy insertion.
详细描述
Left lateral position is conventionally performed to initiate colonoscopy, yet no evidence has demonstrated its efficacy and advantages. Left lateral position for insertion, which results in air rising away from the left colon and producing acute bends in the sigmoid,might increase the risk of colonoscopy loop formation.When there is difficulty advancing the colonoscope, supine position can be employed to ensure cecal intubation. Therefore, we perform a randomized controlled trial to compares supine position with left lateral position for the safety and efficacy of colonoscopy insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 18-75 years
- •underwent screening, surveillance, and diagnostic colonoscopy
排除标准
- •<18 or >75 years old
- •major psychiatric disorders, colonic resection, pregnancy, presence of any contraindications for colonoscopy (eg, severe heart failure, renal insufficiency)
- •Patients with severe cardiopulmonary and renal disease
- •Patients who are unwilling or unable to consent
研究组 & 干预措施
supine position group
干预措施: supine position (Procedure)
left lateral position
结局指标
主要结局
cecal intubation time
时间窗: 2 hour
Cecal intubation time is the insertion time taken from first visualization of rectal mucosa to cecum and cecal intubation was confirmed by identifying the characteristic anatomical landmarks of the triradiate fold, appendiceal orifice, and ileocecal valve.
次要结局
- patients' acceptance to unsedated or sedated colonoscopy in the future screening or examination(3 hour)
- patients' pain score(3 hour)
- descending colon intubation time(1 hour)
研究者
Zhaoshen Li
Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor
Changhai Hospital