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Performance of a disposable colonoscope for routine examination: Pilot randomized controlled noninferiority trial
Xiao-Ling Wang1, Bin-Jia Li1, Huo-Wang Ye1
1Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
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.
Insights
Disposable colonoscopes demonstrated noninferiority to reusable ones in routine colon examinations. While showing some differences in performance, they offer a safe alternative, with experienced endoscopists adapting quickly.
Area of Science:
- Gastroenterology
- Medical Devices
- Infection Control
Background:
- Reusable colonoscopes carry infection risks due to disinfection challenges.
- Disposable colonoscopes offer a potential solution to reduce iatrogenic infections.
- Limited direct comparative data exists between disposable and reusable colonoscope performance.
Purpose of the Study:
- To evaluate the technical performance of disposable colonoscopes versus reusable colonoscopes in routine colon examinations.
- To compare the successful completion rates and safety profiles of both colonoscope types.
- To assess image quality, maneuverability, and other performance metrics.
Main Methods:
- A randomized controlled, noninferiority trial involving 116 patients across two endoscopy centers.
- Patients were randomized to either disposable or reusable colonoscope groups.
- Primary outcome: successful colonoscopy completion rate; Secondary outcomes: imaging, maneuverability, performance measures, adverse events.
Main Results:
- 100% successful colonoscopy completion in both groups, confirming noninferiority.
- Disposable colonoscopes had lower scores for imaging and maneuverability, with longer operating times.
- No significant differences in cecal intubation, polyp detection, or adverse events; rapid learning curve for disposable scopes.
Conclusions:
- Disposable colonoscopes are a safe and viable alternative for routine colon examinations.
- Further technical improvements may enhance disposable colonoscope performance.
- They present a promising option in specific clinical situations, addressing infection control concerns.
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