Background and Aims
Disposable gastroscopes have recently been developed to eliminate the risk of infection
transmission from contaminated reusable gastroscopes. We compared the performance
of disposable and reusable gastroscopes in patients undergoing gastroscopy.
Methods
Patients requiring gastroscopy were randomized to either the disposable or reusable
digital gastroscope group. The primary endpoint was the success rate of photographing
customary anatomic sites, with a noninferiority margin of –8%. Secondary endpoints
were technical performance factors such as gastroscope imaging quality, maneuverability,
gastroscopy completion rate, device failure/defect rate, operating time, and safety.
Data were analyzed using the Newcombe-Wilson score method and Fisher exact 2-tailed
t test.
Results
Of 110 patients, 55 were treated using disposable gastroscopes and 55 using reusable
gastroscopes. The success rate for capturing images of customary anatomic sites was
100% in both groups. The average imaging quality score was significantly lower (37.02
± 3.09 vs 39.47 ± 1.92, P < .001) and the operating time significantly longer (P < .001) in the disposable gastroscope group. No significant differences in maneuverability,
gastroscopy completion rate, device failure/defect rate, operating time, or safety
were found between the 2 groups.
Conclusions
Given the overall safety profile and similar technical performance, disposable gastroscopes
represent an alternative to reusable gastroscopes for routine examination, bedside
first aid, and some certain circumstances.
Abbreviations:
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Article info
Publication history
Published online: April 02, 2022
Accepted:
March 25,
2022
Received:
October 8,
2021
Footnotes
DISCLOSURE: All authors disclosed no financial relationships.
Identification
Copyright
© 2022 by the American Society for Gastrointestinal Endoscopy
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