Patient-posture and Ileal-intubation During Colonoscopy (PIC): a Randomized Controlled Open-label Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Ileal intubation achieved or not
研究概览
简要总结
During colonoscopy, the colonoscopist employs various maneuvers, including changing the patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic examination. Posture change has also been reported to increase the success rate of ileal intubation. However, there has been no randomized trial which has shown that a particular posture of the patient increases the success rate of ileoscopy. The present study will be carried out to determine the impact of the patient's posture (left lateral vs supine position) on success rate of ileal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult (> 12y old) patients referred for colonoscopy
排除标准
- •Acute fulminant colitis
- •Acute Intestinal obstruction
- •Suspected intestinal perforation
- •Peritonitis
- •Pregnancy
- •Severe cardio-respiratory disease (ASA grade...)
- •Decompensated liver disease
- •Recent pelvic or colonic surgery (in last 6 months)
- •Large aortic or ileac artery aneurysm
- •Human Immunodeficiency Virus Infection
- •Uncooperative patients
结局指标
主要结局
Ileal intubation achieved or not
时间窗: After confirmation of cecal intubation for no more than 6 minutes
After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Two points will be assessed: success in ileal intubation and time taken to intubate the ileum. If ileum is not intubated within 6 minutes, it will be considered as failed attempt.
次要结局
- Time taken to intubate the ileum after cecal intubation(6 minutes after cecal intubation and randomisation)
- Depth of ileal intubation(2 minutes)
- Influence of endoscopist experience on successful ileal intubation(6 minutes)
- Abnormal ileal findings(2 minutes)