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阴道镜检查与标准治疗对照:一项随机对照试验。

Vaginoscopy Against Standard Treatment: a randomised controlled trial.

机构信息

Institute of Metabolism and Systems Research, College of Medical & Dental Sciences, University of Birmingham, Birmingham, UK.

Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.

出版信息

BJOG. 2019 Jun;126(7):891-899. doi: 10.1111/1471-0528.15665. Epub 2019 Mar 20.

Abstract

OBJECTIVE

To evaluate whether vaginoscopy or standard hysteroscopy was more successful in the outpatient setting.

DESIGN

Randomised controlled multicentre trial.

SETTING

Outpatient hysteroscopy clinics at two UK hospitals.

POPULATION

1597 women aged 16 or older undergoing an outpatient hysteroscopy.

METHODS

Women were allocated to vaginoscopy or standard hysteroscopy using third party randomisation stratified by menopausal status with no blinding of participants or clinicians.

MAIN OUTCOME MEASURES

The primary outcome was 'success', a composite endpoint defined as: a complete procedure, no complications, a level of pain acceptable to the patient, and no sign of genitourinary tract infection 2 weeks after the procedure.

RESULTS

Vaginoscopy was significantly more successful than standard hysteroscopy [647/726 (89%) versus 621/734 (85%), respectively; relative risk (RR) 1.05, 95% CI 1.01-1.10; P = 0.01]. The median time taken to complete vaginoscopy was 2 minutes compared with 3 minutes for standard hysteroscopy (P < 0.001). The mean pain score was 42.7 for vaginoscopy, which was significantly less than standard hysteroscopy 46.4 (P = 0.02). Operative complications occurred in five women receiving vaginoscopy and 19 women receiving standard hysteroscopy (RR 0.26, 95% CI 0.10-0.69).

CONCLUSIONS

Vaginoscopy is quicker to perform, less painful, and more successful than standard hysteroscopy and therefore should be considered the technique of choice for outpatient hysteroscopy.

TWEETABLE ABSTRACT

Vaginoscopy is quicker to perform, less painful, and more successful than standard hysteroscopy.

摘要

目的

评估阴道镜检查与标准宫腔镜检查在门诊环境中的成功率。

设计

随机对照多中心试验。

地点

英国两家医院的门诊宫腔镜诊所。

人群

1597 名年龄在 16 岁及以上的行门诊宫腔镜检查的女性。

方法

采用第三方随机分组,按绝经状态分层,对患者进行分组,分配至阴道镜检查或标准宫腔镜检查,但不对参与者或临床医生进行设盲。

主要观察指标

主要结局为“成功”,定义为:手术完整、无并发症、患者可接受的疼痛程度以及术后 2 周无泌尿生殖系统感染的迹象。

结果

阴道镜检查明显优于标准宫腔镜检查[647/726(89%)与 621/734(85%);相对风险(RR)1.05,95%置信区间(CI)1.01-1.10;P=0.01]。阴道镜检查完成时间中位数为 2 分钟,而标准宫腔镜检查为 3 分钟(P<0.001)。阴道镜检查的平均疼痛评分(42.7)明显低于标准宫腔镜检查(46.4)(P=0.02)。接受阴道镜检查的 5 名女性和接受标准宫腔镜检查的 19 名女性均发生手术并发症(RR 0.26,95%CI 0.10-0.69)。

结论

阴道镜检查比标准宫腔镜检查操作更快、疼痛更小、成功率更高,因此应考虑作为门诊宫腔镜检查的首选技术。

研究结果表明,与标准宫腔镜检查相比,阴道镜检查在门诊环境中更快、更不痛且成功率更高,因此应成为门诊宫腔镜检查的首选技术。

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