The Role of Left Lateral Tilt-down Position During Colonoscopy Insertion: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- cecal colon insertion time
研究概览
简要总结
The purpose of this study is to determine whether the left lateral tilt-down position, which includes procedures that involve placing patients on their left lateral side at an angle to make their heads lower than their feet, is more beneficial than the left lateral horizontal body position (patient horizontally laying on their left side, traditionally used for colonoscopies) to decrease descending colon insertion time, the difficulty of colonoscopy procedure and patients' pain.
详细描述
Supine with tilt-down position (trendelenburg position) is used in abdominal and gynecological surgery to allow better access to the pelvic organs, as gravity pulls the bowel out of the pelvic cavity and the rectosigmoid angle straightens, which may also be favorable for colonoscopy insertion. However, few published studies have explored the value of tilt-down position in the colonoscopy (left lateral horizontal body position are usually used) and there is consequently little evidence to support left lateral tilt-down position or left lateral horizontal body position. So the investigators perform a randomized controlled trial of left lateral tilt-down position versus left lateral horizontal position for colonoscopy to investigate the safety and efficacy of lateral tilt-down position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Patients whose age is between 18-75
- •Patients who have indications for diagnostic or therapeutic colonoscopy .
- •Patients who have signed inform consent form
排除标准
- •Patients who have undergone colonic resection
- •Patients with glaucoma
- •Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
- •Patients with severe chronic cardiopulmonary and renal disease.
- •Patients with uncontrolled acid reflux disease or active nausea/vomiting.
- •Patients who are unwilling or unable to consent.
- •Patients who are not suitable for colonoscopy
研究组 & 干预措施
left lateral tilt-down position
patients will be positioned on left lateral tilt-down position during colonoscopy until sigmoid-descending junction were examined, and then patients will be positioned on the left lateral horizontal position during colonoscopy
干预措施: left lateral tilt-down position (Procedure)
left lateral horizontal body position
patients will be positioned on the left lateral horizontal position during colonoscopy insertion
干预措施: left lateral horizontal position (Procedure)
结局指标
主要结局
cecal colon insertion time
时间窗: This outcome is measured when cecal colon is intubated during a colonoscopy
次要结局
- decending insertion time(This outcome is measured when decending colon is intubated during a colonoscopy)
- patients' discomfort of colonoscopy(2 hours)
- endoscopists' perception of difficulty of colonoscopy(2 hours)
研究者
Zhaoshen Li
Director of Gastroenterology Dept and Digestive Endoscopy Center
Changhai Hospital