Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Endoscopist-rated composite usability score
研究概览
简要总结
The aim of this clinical trial is to investigate whether single-use gastroscopes perform comparably to reusable gastroscopes when used in an endoscopy unit during a period of reduced endoscope reprocessing capacity.
The main question the study aims to answer is:
- How do endoscopists evaluate the performance of single-use gastroscopes compared with reusable gastroscopes in elective and subacute patients undergoing gastroscopy in the endoscopy unit?
Researchers will compare single-use and reusable gastroscopes to determine whether they provide comparable clinical performance. In addition, the study will evaluate the economic consequences of temporarily implementing single-use gastroscopes during a period of reduced reprocessing capacity, as well as compare selected clinical outcomes, including technical success, procedural complications, and the frequency of endoscopic findings.
Participants undergoing gastroscopy during the first study period will be examined using a single-use gastroscope. Participants undergoing gastroscopy during the second study period will be examined using a reusable 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
- 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
- •Elective or subacute gastroscopy in the endoscopy unit
- •Age ≥ 18 years
排除标准
- •Surveillance gastroscopy for Barrett's esophagus
研究组 & 干预措施
Single-use gastroscope
During the first study period, all gastroscopies performed in the endoscopy unit between 11:00 and 15:00 will be carried out using single-use gastroscopes.
干预措施: Ambu aScope Gastro (Device)
Reusable gastroscope
During the second study period, all gastroscopies performed in the endoscopy unit between 11:00 and 15:00 will be carried out using reusable gastroscopes.
干预措施: Reusable diagnostic gastroscopes (Olympus) (Device)
结局指标
主要结局
Endoscopist-rated composite usability score
时间窗: Procedure day (immediately after completion of the procedure)
Comparison of the composite endoscopist-rated performance score of single-use and reusable gastroscopes. The composite score will be calculated as the mean of all items rated on a 5-point Likert-scale questionnaire.
Cost per gastroscopy during the single-use period compared with the reusable period
时间窗: During the gastroscopy procedure and completion of all procedure-related activities (same day).
Cost per gastroscopy (EUR) will be calculated for each study period using hospital administrative and procedural data. The calculation will include: * Diagnosis-Related Group (DRG) reimbursement value for gastroscopy * Purchase cost of the single-use gastroscope * Reprocessing cost of reusable gastroscopes * Staff time required for preparation and post-procedure work for each gastroscope type * Additional hospital costs associated with transferring patients to other hospitals or private providers due to reduced endoscope reprocessing capacity.
次要结局
- Technical success of single-use gastroscopes vs reusable gastroscopes(During the procedure)
- Cross-over rate(During the procedure)
- Frequency of predefined endoscopic findings(During the procedure)
- Complications(24 hours and 72 hours follow-up after the procedure)
- 30-day mortality(30 days after the procedure)
- Duration of procedure(During the procedure)
- Technical success rate of therapeutic endoscopic procedures(During the procedure)
- Diagnostic adequacy rate of endoscopic biopsies(After completion of the pathology examination (up to 2 months after the procedure))
研究者
Camilla Kjelkvist-Born
Principal Investigator
Zealand University Hospital