Disposable versus reusable gastroscopes: a prospective randomized noninferiority trial

医学 临床终点 外科 随机对照试验
作者
Xiaoya Luo,Ming Ji,Shutian Zhang,Xin Chen,Ye Zong,Xi Zhang,Haiyi Hu,Xiaowen Hao,Linlin Shao,Can Sun,Haiyun Shi,Junxiong Wang,Han Ma,Peng Li
出处
期刊:Gastrointestinal Endoscopy [Elsevier BV]
卷期号:96 (2): 250-261 被引量:15
标识
DOI:10.1016/j.gie.2022.03.024
摘要

Disposable gastroscopes have recently been developed to eliminate the risk of infection transmission from contaminated reusable gastroscopes. We compared the performance of disposable and reusable gastroscopes in patients undergoing gastroscopy.Patients requiring gastroscopy were randomized to either the disposable or reusable digital gastroscope group. The primary endpoint was the success rate of photographing customary anatomic sites, with a noninferiority margin of -8%. Secondary endpoints were technical performance factors such as gastroscope imaging quality, maneuverability, gastroscopy completion rate, device failure/defect rate, operating time, and safety. Data were analyzed using the Newcombe-Wilson score method and Fisher exact 2-tailed t test.Of 110 patients, 55 were treated using disposable gastroscopes and 55 using reusable gastroscopes. The success rate for capturing images of customary anatomic sites was 100% in both groups. The average imaging quality score was significantly lower (37.02 ± 3.09 vs 39.47 ± 1.92, P < .001) and the operating time significantly longer (P < .001) in the disposable gastroscope group. No significant differences in maneuverability, gastroscopy completion rate, device failure/defect rate, operating time, or safety were found between the 2 groups.Given the overall safety profile and similar technical performance, disposable gastroscopes represent an alternative to reusable gastroscopes for routine examination, bedside first aid, and some certain circumstances.
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