Repetitive Position Change After Dimethicone Premedication Improves Gastric Cleanliness for Magnetically Controlled Capsule Endoscopy: a Single-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Image Cleanliness of Gastric Cavity
研究概览
简要总结
By comparing dimethicone administration with/without subsequent repetitive position change before magnetically controlled capsule endoscopy (MCE) examination, the investigators aim to determine the efficacy of repetitive position change in improving gastric cleanliness for MCE examination.
详细描述
This is a single-blind, randomized controlled trial. Subjects receiving magnetically controlled capsule endoscopy at the institution will be randomly allocated into positional change group and conventional group before the procedure. Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination. Gastric cleanliness will be rated by two physicians independently.
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
- Single (Outcomes Assessor)
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
- •Adult patients aged more than 18 years, who were scheduled to undergo a magnetically controlled capsule endoscopy, were eligible for this study.
排除标准
- •Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation;
- •Congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, artificial heart valves;
- •Pregnancy or suspected pregnancy;
- •Exclusion criteria for standard magnetic resonance imaging (MRI) examination such as the presence of surgical metallic devices, even though its low magnetic field would technically not interfere with such devices;
- •Currently participating in another clinical study.
研究组 & 干预措施
Conventional group
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination.
Position change group
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively before undergoing MCE examination.
干预措施: Position change group (Behavioral)
结局指标
主要结局
Image Cleanliness of Gastric Cavity
时间窗: 30 minutes
The image cleanliness of gastric cavity of six primary anatomical landmarks of stomach (cardia, fundus, body, angulus, antrum, and pylorus) were recorded for evaluation. A 4-point grading scale was introduced to define the cleanliness as excellent (no adherent mucus and foam: score 4), good (mild mucus and foam but does not obscure vision: score 3), fair (considerable amount of mucus or foam present precluding a completely reliable examination: score 2) and poor (large amount of mucus or foam residue needing water to clear it: score 1)
次要结局
- The Type of Positive Findings Detected by Magnetically Controlled Capsule Gastroscopy(30 minutes)
- Number of Participants With Adverse Events(2 weeks)
研究者
Zhuan Liao
M.D., Associate Professor, Associate Chief Physician
Changhai Hospital