Study of Two Fasting Procedures Before Gastroscopy: 6 Hours Versus 2 Hours for Clear Fluids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Score for quality of visualization of the esophageal and gastric mucosa
研究概览
简要总结
Upper gastrointestinal endoscopy is the key examination for screening for precancerous and cancerous lesions of the esophagus and stomach. This study aims to describe the quality of the visualization of the esophageal and gastric mucosa, the safety of use of two fasting procedures before gastroscopy and the feeling of patients. The population evaluated here concerns cirrhotic patients, at high risk of developing a precancerous lesion of the upper gastrointestinal tract.
The investigator carries out a prospective, monocentric (Besançon CHRU), interventional and randomized study according to two fasting procedures before gastroscopy: 6 hours (F6 group) versus 2 hours (F2 group) for clear fluids. The primary endpoint was to describe and compare the quality of visualization of the esophageal and gastric mucosa, graded from A (good quality) to C (poor quality) according to a score. developed by Elvas et al. (Endoscopy 2017).
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
- 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
- 否
入选标准
- •Age > 18 years,
- •Male or female
- •Cirrhosis based on radiological, clinical, biological or histological criteria
排除标准
- •Diabetes for more than 10 years;
- •Under 18 years of age;
- •History of inhalation
- •Patients in whom the gastrointestinal anatomy has not been retained
- •Subjects who were unlikely to cooperate with the study and / or in whom poor cooperation was anticipated by the investigator
- •Pregnant women Patients taking drugs that may slow down gastric Emptying such as: anticholinergic drugs, phenothiazines, antidepressants History of esophageal radiotherapy Unsubstituted hypothyroidism
研究组 & 干预措施
Fasting 2 hours
Fasting 2 hours
干预措施: fasting (Procedure)
Fasting 6 hours
Fasting 6 hours
干预措施: fasting (Procedure)
结局指标
主要结局
Score for quality of visualization of the esophageal and gastric mucosa
时间窗: During endoscopy
The score is graded from A (good quality) to C (poor quality) according to a score developed by Elvas et al. (Endoscopy 2017).
次要结局
- Questionnaire concerning security(During endoscopy)
- Questionnaire concerning patient confort during fasting(The day of the endoscopy)