电子宫腔镜在宫腔内诊断和辅助手术中的应用

Application of hysteroscopic electroscopy in intrauterine diagnosis and assisted surgery

摘要

目的 评价一次性电子宫腔镜用于宫腔内诊断和辅助手术的有效性及安全性。方法 本试验于2021年1月至5月在苏州市立医院、浙江大学医学院附属妇产科医院、泰州市人民医院入组136例受试者,1∶1随机分配到试验组或对照组.试验组使用一次性电子宫腔镜进行宫腔内诊断和辅助手术,对照组使用市售宫腔镜进行宫腔内诊断和辅助手术.评价两组图像质量,记录手术情况、试验用器械与手术器械兼容性等。结果 试验组和对照组图像质量优良率差异无统计学意义(P＞0.05),两组对宫颈管、宫腔形态、宫底、宫壁均具有良好成像效果;两组器械均能顺利完成诊断或辅助手术,试验组和对照组试验器械与手术器械的兼容性满意率无统计学差异(91.7% vs. 95.7%, P_Fisher＞0.05);试验组具有良好的进出水性能、摄像性能、图像同步到主机显示器的性能,并具有良好的稳定性,与对照组相比差异无统计学意义(P＞0.05);试验组和对照组不良事件发生率差异无统计学意义(16.2% vs. 10.3%, χ²＝1.024, P＞0.05),且不良事件均与试验器械无关,未发生严重不良事件及器械缺陷。结论 本研究使用的一次性电子宫腔镜能够满足临床诊断和辅助手术需要,且安全性良好.

Abstract

Objective To evaluate the efficacy and safety of single-use electronic hysteroscopy for intrauterine diagnosis and assisted surgery. Methods This trial was conducted from January to May 2021 at Suzhou Municipal Hospital, Women's Hospital School of Medicine Zhejiang University, and Taizhou People's Hospital. A total of 136 participants were enrolled and randomly assigned in a 1:1 ratio to the experimental group or the control group. The experimental group underwent intrauterine diagnosis and assisted surgery using a single-use electronic hysteroscope, while the control group used a commercially available hysteroscope for the same procedures. Image quality was assessed in both groups, and surgical details, as well as the compatibility between the trial device and surgical instruments, were recorded. Results There was no statistically significant difference in excellent image quality rate between the experimental and control groups (P ＞ 0.05). Both groups achieved good imaging of the cervical canal, uterine cavity morphology, fundus, and uterine walls. The diagnostic and assisted surgical procedures were successfully completed in both groups, with no significant difference in the compatibility satisfaction rate between the trial device and surgical instruments (91.7% vs. 95.7%, P_Fisher ＞ 0.05). The experimental group demonstrated good performance in terms of irrigation and suction capabilities, imaging quality, synchronization of images with the main monitor, and overall stability, with no statistically significant differences compared to the control group (P ＞ 0.05). The incidence of adverse events did not significantly differ between the experimental and control groups (16.2% vs. 10.3%, χ² ＝ 1.024, P ＞ 0.05). All adverse events were unrelated to the trial device, and no serious adverse events or device defects occurred. Conclusion The single-use electronic hysteroscope used in this study meets the clinical needs for intrauterine diagnosis and assisted surgery while demonstrating good safety.

关键词

宫腔镜 / 宫腔内诊断 / 辅助手术 / 有效性 / 安全性

Key words

hysteroscopy / intrauterine diagnosis / assisted surgery / efficacy / safety

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基金资助

苏州市科学技术局科研立项项目(SYS2020174)