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新型手动式宫腔镜组织切除器械 Resectr 5fr 在局麻下切除子宫内膜息肉的临床评估。

Clinical evaluation of a new hand-driven hysteroscopic tissue removal device, Resectr 5fr, for the resection of endometrial polyps in an office setting.

机构信息

Women's Clinic, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.

Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.

出版信息

Arch Gynecol Obstet. 2023 Sep;308(3):893-900. doi: 10.1007/s00404-023-06995-w. Epub 2023 Mar 15.

DOI:10.1007/s00404-023-06995-w
PMID:36920533
Abstract

PURPOSE

A first clinical evaluation of a new hand-driven hysteroscopic tissue removal device, Resectr 5fr, for office polypectomy without any anesthesia.

METHODS

Women with at least one small endometrial polyp were eligible. Hysteroscopic polypectomy was performed using the Resectr 5fr in an office setting, without any anesthesia.

RESULTS

One hundred and two hysteroscopic polypectomies were included in the analysis. The median installation time was 1.9 min (95% confidence interval (CI) 1.6-2.1). The median time to complete polyp removal was 1.2 min (95% CI 0.8-1.6). The median surgeon's safety, practical, and comfort scores on a 5-point Likert scale were high (5 (5-5), 5 (4-5), and 5 (4-5), respectively). Women's pain score was low (median 1 (0-3)), whereas the satisfaction rate was high (median 5 (5-5)), both on a 5-point Likert scale. There were two conversions (hysteroscopic scissors (n = 1), a new Resectr 5fr device (n = 1)). There was one incomplete procedure (tissue hardness).

CONCLUSION

Hysteroscopic removal of small polyps, using the [Formula: see text] 5fr in an office setting is feasible in terms of installation and resection time. Surgeon's practical, comfort, and safety scores are high, whereas women report low pain scores and high satisfaction rates.  TRIAL REGISTRATION: Dutch Clinical Trial Registry (NTR 7119, NL6923): https://www.trialregister.nl/trial/6923 . Date of registration: 27/03/2018.

摘要

目的

评估一种新型手动式宫腔内组织切除装置 Resectr 5fr 在无需任何麻醉的情况下于门诊行宫腔镜息肉切除术的初步临床效果。

方法

纳入至少有一个小子宫内膜息肉的女性。在门诊环境下使用 Resectr 5fr 行宫腔镜息肉切除术,无需任何麻醉。

结果

共纳入 102 例宫腔镜息肉切除术,分析装置安装中位时间为 1.9 分钟(95%置信区间 1.6-2.1),切除息肉中位时间为 1.2 分钟(95%置信区间 0.8-1.6)。5 分制 Likert 量表中,医生对安全性、实用性和舒适度的评分均较高(5(5-5)、5(4-5)和 5(4-5))。女性疼痛评分为低(中位数 1(0-3)),满意度评分较高(中位数 5(5-5))。共 2 例(宫腔镜剪刀 1 例,新 Resectr 5fr 装置 1 例)中转开腹,1 例(组织硬度)手术未完成。

结论

Resectr 5fr 装置在门诊用于切除小息肉时,安装和切除时间均具有可行性。医生对实用性、舒适度和安全性的评分较高,而女性疼痛评分较低,满意度评分较高。

试验注册

荷兰临床试验注册中心(NTR7119,NL6923):https://www.trialregister.nl/trial/6923。注册日期:2018 年 3 月 27 日。

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