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

Abstract

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. 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. 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. Compared with reusable endoscopes, disposable endoscopes are equally safe, feasible, and reliable in ERBL for internal hemorrhoids.