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.
Elective or subacute gastroscopy in the endoscopy unit
Age ≥ 18 years
Surveillance gastroscopy for Barrett's esophagus
Parallel
Ambu aScope Gastro
DeviceCE-marked single-use gastroscopes from Ambu are used in the single-use group.
Reusable diagnostic gastroscopes (Olympus)
DeviceReusable diagnostic gastroscopes from Olympus are used in the reusable group.
Endoscopist-rated composite usability score
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
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.
Technical success of single-use gastroscopes vs reusable gastroscopes
Technical success will be determined by retrospective review of the endoscopy report and medical record using predefined study criteria. Technical success is defined as successful advancement of the gastroscope to the second part of the duodenum and the ability to identify or exclude the suspected diagnosis. In procedures with an impassable stenosis or tumor, technical success is defined as successful identification of the lesion and obtaining biopsies sufficient for diagnostic evaluation when clinically indicated. The outcome will be reported as the proportion of procedures meeting the predefined criteria for technical success.
Cross-over rate
Frequency of gastroscopies requiring cross-over to another gastroscope
Frequency of predefined endoscopic findings
Endoscopic findings will be determined by retrospective review of the endoscopy report using predefined study categories. The frequency of each predefined endoscopic finding will be compared between the single-use and reusable gastroscope groups.
Complications
Complications related to gastroscopy
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