One-Scope II: Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- intraprocedural technical success
研究概览
简要总结
Controlled-randomized trial evaluating single-use versus reusable gastroscopes in patients with upper gastrointestinal bleeding.
详细描述
Acute upper gastrointestinal bleeding is a common medical emergency. According to guidelines, endoscopic evaluation should be performed within 24 hours. With an overall high incidence and an overall high number of diagnostic and therapeutic endoscopic procedures, the introduction of new endoscopic concepts may have a profound impact on outcomes as well as cost-effectiveness in upper gastrointestinal bleeding. For this purpose, the use of single-use gastroscopes represents an interesting possibility. Hygiene issues in the emergency situation are also relevant. The previous feasibility study One-Scope I demonstrated that the diagnosis as well as the therapy of upper gastrointestinal bleeding is possible with single-use gastroscopes. In this follow-up study, the investigators compare the use of single-use versus reusable gastroscopes in participants with suspected upper gastrointestinal bleeding in a randomized controlled trial.
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
- 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
- •Glasgow-Blatchford score (GBS) >2
- •Clinical signs of upper bleeding
排除标准
- •pregnancy
- •Unable to provide consent
结局指标
主要结局
intraprocedural technical success
时间窗: Up to 20 minutes
defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site
次要结局
- Length of intervention(Up to 60 minutes)
- blood transfusions(Up to 30 days)
- re-bleeding rate(Up to 30 days)
- Length of Stay(Up to 30 days)
- intraprocedural clinical success(Up to 45 Minutes)
- Adverse events(Up to 30 days)
- cross over to reusable gastroscope(Up to 60 Minutes)