关键词: 一次性使用电子宫腔镜, 重复使用宫腔镜, 宫腔镜检查

Abstract: Objective To compare the efficacy and safety of single-use digital hysteroscope and reusable hysteroscope for outpatient hysteroscopy．Methods A parallel randomized control method was used in three clinical trials institutions．Eighty-two cases of outpatient patients who used single-use digital hysteroscope for hysteroscopy were included in experimental group,and 82 cases who underwent hysteroscopy by reusable hysteroscope（Storz Bettochi）were included in control group．The clinical diagnosis coincidence rate,performance score and incidence of adverse events of uterine imaging were recorded in the two groups．Results The coincidence rate of clinical diagnosis in the experimental group was 98.8%（80/82）,1.22% lower than the 100%（82/82）in control group．And the difference of lower limit of 95% confidence interval between the experimental group and the control group was-3.60%,which was greater than the non-inferiority margin-10.00%．There was no significant difference in performance scores between the experimental group and the control group（P>0.05）．The incidence of adverse events in the experimental group was 11.0%（9 cases,9 events）,and serious adverse events incidence was 1.2%（1 case,1 event）．In the control group,the incidence of adverse events was 9.8%（8 cases,9 events）,and no serious adverse events occurred（0 cases,0 events）．There was no significant difference in the incidence of adverse events or serious adverse events between two groups．Conclusions The overall performance of single-use digital hysteroscope for providing intrauterine images,observation and diagnosis is comparable to that of reusable hysteroscope,and the safety is also comparable．The performance of the single-use digital hysteroscope can meet the needs of outpatient hysteroscopy,and it can be an effective supplementary hysteroscopy technology．

Key words: single-use digital hysteroscope, reusable hysteroscope, hysteroscopy