Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes in the Endoscopy Unit for Subacute Patients

What this Trial Is About

This research investigates whether using single-use gastroscopes at the bedside can reduce the time from the decision to perform an early gastroscopy compared to using reusable gastroscopes in the endoscopy unit. The study focuses on patients referred for subacute gastroscopy and aims to assess performance and technical outcomes of these two approaches. It is sponsored by Zealand University Hospital and involves adult patients admitted to the surgical department. Participants will be divided into two groups based on the study period. In the first period, gastroscopies are performed in the endoscopy unit using reusable Olympus gastroscopes. In the second period, gastroscopies are conducted at the patient's bedside using CE-marked single-use Ambu aScope Gastro gastroscopes. Both procedures are done without general anesthesia, and the study is non-randomized. During the study, researchers will measure the time from indication to procedure, procedure duration, technical success, sedation needs, complications, and patient outcomes such as discharge timing and readmissions. Additional assessments include biopsy targeting ability, endoscopist ratings, and nurse learning curves. Follow-up will cover up to three months post-procedure, with safety monitoring at 24, 72 hours, and 30 days. The total duration depends on timing from indication to discharge and follow-up periods.

Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients