Early Esophagogastroduodenoscopy Performed Bedside Using Single-use Disposable Endoscope - A Prospective Non-randomized Controlled Single Centre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Time from the indication/decision for early endoscopy to procedure
研究概览
简要总结
We aim to evaluate whether the use of single-use gastroscopes at the bedside can reduce the time from clinical indication to procedure compared to reusable gastroscopes used in the endoscopy unit for patients referred for subacute gastroscopy.
Participants in the first period will be scheduled for gastroscopy with a reusable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the hospital department (bed-side) with a single-use gastroscope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients of any gender, 18 years of age or older
- •Diagnostic EGD without general anaesthesia
排除标准
- •ASA-score of 4 or higher
- •Unstable patient
- •Suspicion of active bleeding
- •Anticoagulants not withheld due to regional guidelines
结局指标
主要结局
Time from the indication/decision for early endoscopy to procedure
时间窗: From indication to procedure, up to two weeks
Endoscopists' rating of the gastroscope
时间窗: Immediately after procedure
The endoscopists' rating of the gastroscope
次要结局
- Time from admission to procedure(From admission to procedure, up to 3 months)
- Time from procedure to discharge(From procedure to discharge, up to 3 months)
- Duration of the procedure(During the procedure)
- Did the patient need sedation or local anaesthetic throat spray?(During the procedure)
- Technical success(From admission to discharge, up to 3 months)
- Complications to gastroscopy(24 and 72 hour follow-up after procedure)
- Need for converting to general anaesthesia or reusable gastroscope(During admission, up to 3 months)
- Findings during the procedure(During the procedure)
研究者
Camilla Kjelkvist-Born
Principal Investigator
Zealand University Hospital