The Effectiveness of Improved Use of Chewing Gum in Influencing Capsule Endoscopy Transit Time: A Prospective Randomized, Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- gastric transit time
研究概览
简要总结
The purpose of this study is to determine the effect of chewing gum, during the first one hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of cases with complete small bowel examination and gastroscopy intervention.
详细描述
The participants will include patients who need to a capsule endoscopy (CE) in this unit. The investigators will include 200 participants who had a CE at our centre based on the gastric transit times. These will be randomly divided into two groups. The participants (chew chewing gum) and the controls (do not chew chewing gum).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The patients were instructed not to tell the endoscopist or the investigators about whether or not they used chewing gum before, during, or after the SBCE procedure.
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years and <80 years old presenting for capsule endoscopy. Obtained of written informed consent before the procedure.
排除标准
- •Patients on motility enhancing and/or slowing drugs(narcotics/prokinetics) should stop these at least 7 days prior to the procedure.
- •Patients, who have proven or suspected obstruction of the bowel.
- •Patients, who have had prior small bowel and/or gastric surgery.
- •Patients, who have a dysphagia prohibiting.
- •Patients with diabetes mellitus and/or hypo-/hyper-thyroidism.
结局指标
主要结局
gastric transit time
时间窗: 1 hour
the time interval between the first gastric image and the first duodenal image
small bowel transit time
时间窗: 8 hour
The time interval between the first duodenal images and the first caecal image
次要结局
- Diagnostic yield(9 hours)
- Completion rate(9 hours)
- Intervention rate(1 hours)