Evaluation of the safety and effectiveness of the disposable endoscope for endoscopic rubber band ligation of internal hemorrhoids: A prospective randomised controlled trial

Abstract

Purpose We aimed to compare not only the safety and effectiveness of endoscopic rubber band ligation (ERBL) for treating grade II-III internal hemorrhoids using disposable endoscopes versus reusable endoscopes, but also maintenance cost of them. Method This was a prospective randomised controlled trial with 42 patients who underwent ERBL for grade II-III internal hemorrhoids using either a disposable endoscope (n = 21) or a reusable endoscope (n = 21). Safety was assessed by postoperative infection rate, in-procedure vital stability, and incidence of device-related adverse events. Effectiveness was assessed by endoscopic image clarity, flexibility, matching between the endoscope and surgical instrument, and therapeutic effect. Cost accounting of maintenance was also estimated. Results In terms of safety, although neutrophil count on a postoperative day (POD) 1 in the disposable endoscope group was significantly higher than in the reusable endoscope group (P = 0.008), no patients in either group had a postoperative infection. No life-threatening events, equipment failure or device-related adverse effects occurred during the procedures in either group. In terms of effectiveness, image clarity (P = 0.599) and endoscopic flexibility (P = 0.057) were mildly inferior in disposable endoscope group, but no significant differences were found. Matching between the endoscope and ligating device was 100% in both groups. The therapeutic effects on POD 30 were similar in both groups (P = 0.611). The maintenance cost of reusable endoscope was 214.74RMB per case when disposable endoscope was 0. Conclusion Compared with reusable endoscopes, disposable endoscopes are equally safe, feasible, and reliable in ERBL for internal hemorrhoids, and maintenance cost can be totally saved. Clinical trial registration was completed (ChiCTR2200060014) on May 14, 2022.