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移除 Essure 绝育装置:荷兰的一项回顾性队列研究。

Removal of Essure Sterilization Devices: A Retrospective Cohort Study in the Netherlands.

机构信息

Department of Obstetrics and Gynecology, Meander Medisch Centrum, Amersfoort, Netherlands (Dr. Maassen).

Department of Obstetrics and Gynecology, Jeroen Bosch Ziekenhuis, 's Hertogenbosch, Netherlands (Dr. van Gastel).

出版信息

J Minim Invasive Gynecol. 2019 Sep-Oct;26(6):1056-1062. doi: 10.1016/j.jmig.2018.10.009. Epub 2018 Oct 16.

Abstract

STUDY OBJECTIVE

To analyze short-term effectiveness and symptom resolution after surgical removal of Essure (Bayer AG, Leverkusen, Germany) sterilization devices.

DESIGN

A single-center retrospective cohort study (Canadian Task Force classification III).

SETTING

A large secondary care teaching hospital in the Netherlands.

PATIENTS

All patients who underwent surgical removal of Essure devices between January 2009 and December 2015.

INTERVENTIONS

Surgical removal of Essure devices was predominantly performed by laparoscopic surgery. In the majority of patients, Essure devices were removed by performing bilateral salpingectomy (66.6%).

MEASUREMENTS AND MAIN RESULTS

Data regarding patient characteristics, symptoms, the insertion procedure, the removal procedure, results of the pathological assessment, and follow-up were extracted from patient files. A total of 93 patients had Essure devices removed in the selected period. The onset of symptoms after Essure sterilization was variable. The most frequently reported symptom was abdominal pain (69.9%) followed by lower back pain and fatigue. Most patients reported multiple symptoms; 39.8% of women reported complete relief of symptoms after removal surgery, whereas 15.1% did not notice any relief in symptoms.

CONCLUSION

Six weeks after removal surgery, 39.8% of patients reported complete resolution of symptoms. Further research to reported symptoms after Essure sterilization and symptom resolution after removal surgery is necessary to inform both patients and gynecologists in order to make a well-considered decision about taking the risks of (major) surgery and the expected benefits of removal.

摘要

研究目的

分析经手术移除 Essure(拜耳公司,德国勒沃库森)绝育装置后的短期疗效和症状缓解情况。

设计

单中心回顾性队列研究(加拿大任务组分类 III 级)。

地点

荷兰一家大型二级保健教学医院。

患者

2009 年 1 月至 2015 年 12 月期间接受 Essure 装置手术取出的所有患者。

干预措施

Essure 装置的手术取出主要通过腹腔镜手术进行。在大多数患者中,通过双侧输卵管切除术(66.6%)取出 Essure 装置。

测量和主要结果

从患者档案中提取了有关患者特征、症状、插入程序、取出程序、病理评估结果和随访的数据。在选定的时间段内,共有 93 名患者取出了 Essure 装置。Essure 绝育后的症状发作时间各不相同。报告最多的症状是腹痛(69.9%),其次是下腰痛和疲劳。大多数患者报告有多种症状;39.8%的女性在取出手术后症状完全缓解,而 15.1%的女性没有注意到症状有任何缓解。

结论

取出手术后 6 周,39.8%的患者报告症状完全缓解。需要进一步研究 Essure 绝育后报告的症状和取出手术后的症状缓解情况,以便为患者和妇科医生提供信息,以便对(重大)手术的风险和预期的获益做出明智的决策。

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