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比较三种活检钳在绝经后患者宫腔镜子宫内膜活检中的应用(HYGREB-1):一项多中心、单盲、随机临床试验。

Comparison of three biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal patients (HYGREB-1): A multicenter, single-blind randomized clinical trial.

机构信息

Obstetrics and Gynecology Unit, Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.

Department of Obstetrics and Gynecology, "Filippo Del Ponte" Hospital, University of Insubria, Varese, Italy.

出版信息

Int J Gynaecol Obstet. 2021 Dec;155(3):425-432. doi: 10.1002/ijgo.13669. Epub 2021 Apr 4.

Abstract

OBJECTIVE

To compare three types of biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal women.

METHODS

Postmenopausal women undergoing operative hysteroscopy with endometrial biopsy for abnormal uterine bleeding or endometrial thickness (≥5 mm) were included. Operative hysteroscopy with endometrial biopsy was performed by hysteroscopic forceps. Women were randomized (1:1:1 ratio) in three groups and allocated to undergo endometrial biopsy by hysteroscopy using spoon, alligator, or snake forceps.

RESULTS

Seventy-five women were included in the study, 25 in each group. The duration of the biopsy was comparable between the three groups (P = 0.334) with a median of 180 seconds (range 20-480 seconds). No differences were observed about the number of attempts (P = 0.602), the use of another instrument (P = 0.276), and the biopsy appropriateness (P = 0.592). The spoon forceps group reported higher levels of pain compared to the alligator and snake forceps groups (P < 0.001). The spoon forceps received significantly lower scores by the operator compared to the alligator and snake forceps (P < 0.001). The alligator and snake forceps reported wider biopsy than the spoon forceps (P < 0.001).

CONCLUSION

Snake and alligator hysteroscopic forceps may be considered the first choice to perform an endometrial biopsy in postmenopausal women. ClinicalTrials.gov: NCT03427957.

摘要

目的

比较三种活检钳在绝经后妇女宫腔镜子宫内膜活检中的应用。

方法

纳入因异常子宫出血或子宫内膜厚度(≥5mm)而行手术性宫腔镜检查并同时进行子宫内膜活检的绝经后妇女。采用宫腔镜活检钳进行手术性宫腔镜检查和子宫内膜活检。将患者按 1:1:1 的比例随机分为三组,分别采用宫腔镜勺状、鳄嘴状和蛇状活检钳进行子宫内膜活检。

结果

本研究共纳入 75 例患者,每组 25 例。三组间活检持续时间无差异(P=0.334),中位数为 180 秒(范围 20-480 秒)。三组间尝试次数(P=0.602)、使用其他器械(P=0.276)和活检适宜性(P=0.592)均无差异。与鳄嘴状和蛇状活检钳组相比,勺状活检钳组报告的疼痛程度更高(P<0.001)。与鳄嘴状和蛇状活检钳组相比,操作者对勺状活检钳的评分明显较低(P<0.001)。与勺状活检钳相比,鳄嘴状和蛇状活检钳的活检范围更宽(P<0.001)。

结论

在绝经后妇女中,蛇状和鳄嘴状宫腔镜活检钳可能是进行子宫内膜活检的首选。ClinicalTrials.gov:NCT03427957。

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