Evaluation of a novel disposable endoscope for retroflexed endoscopic rubber band ligation of internal hemorrhoids: a randomized pilot study

Wen Xu,Guili Xia, Laihe Li, Ge Cao, Xianhuan Yan, Ling Dong,Ying Zhu

POSTGRADUATE MEDICAL JOURNAL(2024)

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摘要
Purpose Retroflexed endoscopic rubber band ligation (ERBL) for treating Grade II and III internal hemorrhoids using disposable endoscopes has not been previously assessed. We therefore compared the safety and effectiveness of ERBL for internal hemorrhoids using novel disposable endoscopes versus traditional reusable endoscopes.Methods This prospective randomized controlled trial involved 42 patients who underwent ERBL for Grade II and III internal hemorrhoids using either a disposable endoscope (n = 21) or a reusable endoscope (n = 21). Safety was assessed by the incidence of equipment failure, device-related adverse events, and in-procedure stability of vital signs. Effectiveness was assessed by the postoperative therapeutic effect, feasibility of retroflexed ERBL, and incidence of complications.Results In terms of safety, no life-threatening events, equipment failure, or device-related adverse effects occurred during the procedures in either group. The rate of diastolic blood pressure stability was significantly different between the two groups (P = .049), but the rates of systolic blood pressure and heart rate stability were similar. In terms of effectiveness, the therapeutic effects on postoperative Day 30 were similar in both groups. Image clarity and endoscopic flexibility in the disposable endoscope group were mildly inferior to those in the reusable endoscope group, but without statistical significance. Matching between the endoscope and ligating device was 100% in both groups. The incidence of complications on postoperative Days 1 and 10 was not significantly different between the two groups.Conclusion Compared with reusable endoscopes, disposable endoscopes are equally safe, feasible, and reliable in ERBL for internal hemorrhoids. What is already known on this topic Reusable endoscopes cannot be completely sterile even after standard disinfection. Disposable endoscopes can avoid the procedures of sterilizing. What this study adds Retroflexed ERBL for Grade II and III internal hemorrhoids can be performed by disposable endoscopes, as safe and effective as traditional reusable endoscopes. How this study might affect research, practice or policy Disposable endoscopes can be used for retroflexed ERBL for internal hemorrhoids especially in some circumstances such as endemic area or emergency bedside endoscopy.
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关键词
endoscopes,effectiveness,hemorrhoids,ligation,safety
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