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使用组织切除装置或电外科圈套器进行子宫内膜息肉切除术:一项随机对照试验。

Endometrial polypectomy using tissue removal device or electrosurgical snare: a randomised controlled trial.

作者信息

van Gemert J, Herman M C, Beelen P, Geomini P M, Bongers M Y

出版信息

Facts Views Vis Obgyn. 2022 Sep;14(3):235-243. doi: 10.52054/FVVO.14.3.035.

DOI:10.52054/FVVO.14.3.035
PMID:36206798
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10350946/
Abstract

BACKGROUND

Hysteroscopic transcervical resection of endometrial polyps is a widely used method and is increasingly performed in office or outpatient care. To ensure patient comfort is key, smaller instruments are preferred while also achieving a complete resection of the pathology.

OBJECTIVES

To evaluate the effectiveness of the electrosurgical polyp snare (DPS) in comparison with a tissue removal device (TRD).

MATERIALS AND METHODS

This was a randomised controlled non-inferiority trial which included 66 women with symptomatic endometrial polyps who had been referred to the gynaecological outpatient clinic at the Máxima Medical Centre, Veldhoven, the Netherlands. The patients were randomly allocated by using sealed envelopes to treatment with either the DPS (Duckbill®, Cook) or the TRD (Truclear™, Medtronic). Clinicians and patients were not blinded to the treatment performed. An independent observer blindly assessed the results.

MAIN OUTCOME MEASURES

The primary outcome was the complete removal of the endometrial polyp. Secondary outcomes were woman acceptability and pain during the procedure, operating time, peri-operative and immediate postoperative complications.

RESULTS

57% of the polyps in the DPS group and 95% in the TRD group were completely removed (risk difference -0.39; 95% CI: -0.60 to -0.15). Average operating time was longer with DPS compared to the TRD (11.7 min. vs. 6.8 min., p = 0.018). The number of insertions of the hysteroscope was higher with the DPS compared to the TRD (3.9 vs. 1.7, p <0.001). One serious adverse event, a uterine perforation, occurred in the DPS group.

CONCLUSION

The TRD was superior to the DPS in completeness of polyp removal.

WHAT IS NEW?: TRD has a higher rate of complete polyp resection, overall safety and higher patient satisfaction, this instrument should be considered as the preferred option in outpatient and office gynaecology.

摘要

背景

宫腔镜下经宫颈子宫内膜息肉切除术是一种广泛应用的方法,越来越多地在门诊或门诊护理中进行。确保患者舒适是关键,在实现病理完全切除的同时,较小的器械更受青睐。

目的

评估电外科息肉圈套器(DPS)与组织切除装置(TRD)相比的有效性。

材料与方法

这是一项随机对照非劣效性试验,纳入了66名有症状的子宫内膜息肉女性患者,她们被转诊至荷兰费尔德霍芬马克西玛医疗中心的妇科门诊。患者通过使用密封信封随机分配接受DPS(Duckbill®,库克公司)或TRD(Truclear™,美敦力公司)治疗。临床医生和患者对所进行的治疗不设盲。一名独立观察者对结果进行盲法评估。

主要观察指标

主要结局是子宫内膜息肉的完全切除。次要结局包括女性的可接受性、手术过程中的疼痛、手术时间、围手术期和术后即刻并发症。

结果

DPS组57%的息肉和TRD组95%的息肉被完全切除(风险差异-0.39;95%置信区间:-0.60至-0.15)。与TRD相比,DPS的平均手术时间更长(11.7分钟对6.8分钟,p = 0.018)。与TRD相比,DPS的宫腔镜插入次数更多(3.9次对1.7次,p <0.001)。DPS组发生了1例严重不良事件,即子宫穿孔。

结论

在息肉切除的完整性方面,TRD优于DPS。

新发现是什么?:TRD的息肉完全切除率更高、总体安全性更高且患者满意度更高,该器械应被视为门诊和办公室妇科的首选选项。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82d3/10350946/1e0f44625324/FVVinObGyn-14-235-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82d3/10350946/bdcf6049c886/FVVinObGyn-14-235-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82d3/10350946/1e0f44625324/FVVinObGyn-14-235-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82d3/10350946/bdcf6049c886/FVVinObGyn-14-235-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82d3/10350946/1e0f44625324/FVVinObGyn-14-235-g002.jpg

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本文引用的文献

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Mechanical hysteroscopic tissue removal or hysteroscopic morcellator: understanding the past to predict the future. A narrative review.机械性宫腔镜组织切除术或宫腔镜粉碎器:了解过去以预测未来。一篇叙述性综述。
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Intraoperative and Postoperative Clinical Evaluation of the Hysteroscopic Morcellator System for Endometrial Polypectomy: A Prospective, Randomized, Single-blind, Parallel Group Comparison Study.
宫腔镜子宫内膜息肉切除术用旋切器系统的术中及术后临床评估:一项前瞻性、随机、单盲、平行组比较研究
Gynecol Minim Invasive Ther. 2018 Jan-Mar;7(1):16-21. doi: 10.4103/GMIT.GMIT_6_17. Epub 2018 Feb 16.
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Diagnostic workup for postmenopausal bleeding: a randomised controlled trial.绝经后出血的诊断性检查:一项随机对照试验。
BJOG. 2017 Jan;124(2):231-240. doi: 10.1111/1471-0528.14126. Epub 2016 May 26.
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Factors Influencing the Recurrence Potential of Benign Endometrial Polyps after Hysteroscopic Polypectomy.宫腔镜息肉切除术后影响良性子宫内膜息肉复发可能性的因素
PLoS One. 2015 Dec 11;10(12):e0144857. doi: 10.1371/journal.pone.0144857. eCollection 2015.
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Removal of Endometrial Polyps: Hysteroscopic Morcellation versus Bipolar Resectoscopy, A Randomized Trial.子宫内膜息肉切除术:宫腔镜旋切术与双极电切术的随机对照试验
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