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宫腔镜下 Essure(®)绝育术的并发症:单中心 4306 例手术报告。

Complications of hysteroscopic Essure(®) sterilisation: report on 4306 procedures performed in a single centre.

机构信息

Department of Obstetrics and Gynaecology, 'Reina Sofía' University Hospital, Córdoba, Spain.

出版信息

BJOG. 2012 Jun;119(7):795-9. doi: 10.1111/j.1471-0528.2012.03292.x. Epub 2012 Feb 23.

DOI:10.1111/j.1471-0528.2012.03292.x
PMID:22360159
Abstract

OBJECTIVE

To analyse the short-, medium- and long-term complications in women undergoing hysteroscopic tubal sterilisation with the Essure(®) device.

DESIGN

Retrospective 7-year study.

SETTING

Office hysteroscopic unit in a teaching hospital.

SAMPLE

A total of 4306 women whoe underwent the Essure(®) sterilisation procedure from 2003 to 2010.

METHODS

Data on the success of the procedure and complications arising from outpatient hysteroscopic sterilisation using the Essure(®) system were collected from consecutive women undergoing the procedure over a 7-year period.

MAIN OUTCOME MEASURES

Placement rate, successful bilateral tubal occlusion, perioperative adverse events, early postoperative (during the first 3 months of follow-up) and late complications (after the initial 3 months of follow-up).

RESULTS

A total of 4108 (96.8%) women completed the standard 3-month follow-up protocol. Only 534 (13%) women had undergone the procedure within the previous year. There were 115 (out of 4306; 2.7%) recorded complications, none of which resulted in the need for hospitalisation or discharge later than 2 hours after the procedure. Vasovagal syncope was the most frequently encountered adverse event, occurring in 85 (2.0%) of 4306 cases. In 19 cases, one device was expelled, with most expulsions (14 out of 19) being detected before or during the 3-month follow-up.

CONCLUSIONS

Outpatient hysteroscopic sterilisation using the Essure(®) system is safe, with a low rate of complications.

摘要

目的

分析行宫腔镜输卵管绝育术的妇女在短期、中期和长期的并发症。

设计

回顾性 7 年研究。

地点

教学医院门诊宫腔镜室。

样本

共 4306 名于 2003 年至 2010 年间行 Essure(®)绝育术的妇女。

方法

收集连续接受 Essure(®)系统门诊宫腔镜绝育术的妇女在 7 年内的手术成功率和并发症数据。

主要观察指标

放置率、双侧输卵管闭塞成功、围手术期不良事件、早期术后(随访前 3 个月内)和晚期并发症(随访初始 3 个月后)。

结果

共 4108 名(96.8%)妇女完成了标准的 3 个月随访方案。仅有 534 名(13%)妇女在过去 1 年内接受了该手术。共记录到 115 例(4306 例中的 13%)并发症,无一例需要住院治疗或在手术后 2 小时内出院。血管迷走神经性晕厥是最常见的不良事件,发生在 4306 例中的 85 例(2.0%)。19 例中有 1 个器械被排出,其中大多数(14 例)在 3 个月随访前或随访期间被发现。

结论

使用 Essure(®)系统行门诊宫腔镜绝育术安全,并发症发生率低。

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