Performance of a disposable colonoscope for routine examination: Pilot randomized controlled noninferiority trial (with video).

Objectives: Reusable colonoscopes pose a risk of iatrogenic infections due to improper disinfection and maintenance, prompting the development of disposable colonoscopes. However, direct comparisons between disposable and reusable colonoscopes remain limited. This pilot study aimed to evaluate the technical performance of disposable colonoscopes compared to reusable ones for routine colon examinations.

Methods: This randomized controlled, noninferiority study was conducted at two endoscopy centers. Patients requiring colonoscopy were randomly assigned to either the disposable or reusable colonoscope group. The primary outcome was the successful completion rate of colonoscopy between the groups, with a noninferior margin of -10%. Secondary outcomes included image characteristics, technical maneuverability, colonoscopy performance measures, and adverse events.

Results: A total of 116 patients underwent colonoscopy (58 in each group). The successful completion rate of colonoscopy was 100% in both groups (difference: 0% [95% confidence interval -6.21% to 6.21%]), confirming noninferiority. Although the disposable colonoscope group had lower performance scorings in imaging characteristics, technical maneuverability, and longer operating time compared to the reusable colonoscope group, no significant differences were observed in cecal intubation rate, polyp detection rate, polyp characteristics, or adverse event rate. Additionally, experienced endoscopists achieved proficiency with disposable colonoscopes after approximately 10 cases, requiring minimal training.

Conclusion: With further technical advancements, disposable colonoscopes may serve as a safe and viable alternative to reusable colonoscopes for routine colon examinations in certain clinical scenarios.