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随机研究阴道镜检查和 H Pipelle 与传统宫腔镜检查和标准 Pipelle 的比较。

Randomized study of vaginoscopy and H Pipelle vs traditional hysteroscopy and standard Pipelle.

机构信息

Department of Obstetrics and Gynecology, Queen Mary Hospital, University of Hong Kong, Hong Kong, China.

出版信息

J Minim Invasive Gynecol. 2012 Mar-Apr;19(2):206-11. doi: 10.1016/j.jmig.2011.12.007. Epub 2012 Jan 20.

DOI:10.1016/j.jmig.2011.12.007
PMID:22265052
Abstract

STUDY OBJECTIVE

To compare the use of vaginoscopic vs traditional hysteroscopy in evaluation of the endometrial cavity.

DESIGN

Prospective, randomized, single blinded, clinical trial (Canadian Task Force classification I).

SETTING

University-affiliated hospital in Hong Kong.

PATIENTS

Ninety women scheduled to undergo diagnostic hysteroscopy without anesthesia.

INTERVENTIONS

Women were randomized to undergo either vaginoscopic hysteroscopy using the H Pipelle for endometrial sampling (n = 45) or traditional hysteroscopy using the standard Pipelle (n = 45). Both procedures were performed without anesthesia and using a rigid 4.5-mm hysteroscope. Main outcome measures analyzed were pain scores using a 10-point visual analog scale during hysteroscopy, endometrial biopsy, and overall pain score of the procedure, success and duration of each procedure, and adequacy of the endometrial sample obtained.

MEASUREMENTS AND MAIN RESULTS

The success rates for vaginoscopic and traditional hysteroscopy were 93.33% and 100%, respectively (p = .24). There was no significant difference in the mean pain score and procedure duration between the 2 hysteroscopic approaches. Endometrial sampling using the H Pipelle was significantly quicker by about 45 seconds compared with use of the standard Pipelle (mean [SD] duration, 1.46 [0.72] min vs 2.20 [1.19] min, respectively; p = .001), with similar biopsy adequacy. Most women (95.5% in both approaches) found the procedure acceptable. There were no intraoperative or postoperative complications.

CONCLUSIONS

Vaginoscopic and traditional hysteroscopic approaches are similar in safety, feasibility, and associated pain. Although the time needed to obtain an endometrial sample using the H Pipelle was quicker than with the standard Pipelle, there is no difference in overall procedure duration.

摘要

研究目的

比较阴道镜与传统宫腔镜检查在评估子宫内膜腔中的应用。

设计

前瞻性、随机、单盲、临床试验(加拿大任务组分类 I)。

设置

香港大学附属医院。

患者

90 名计划在无麻醉下接受诊断性宫腔镜检查的女性。

干预措施

将患者随机分为两组,分别使用 H Pipelle 进行阴道镜宫腔镜检查进行子宫内膜取样(n = 45)或使用标准 Pipelle 进行传统宫腔镜检查(n = 45)。两种方法均在无麻醉和使用刚性 4.5mm 宫腔镜下进行。主要观察指标为宫腔镜检查、子宫内膜活检和整个手术过程中的疼痛评分(使用 10 分视觉模拟评分)、两种方法的成功率和手术时间以及获得的子宫内膜样本的充足性。

测量和主要结果

阴道镜和传统宫腔镜检查的成功率分别为 93.33%和 100%(p =.24)。两种宫腔镜方法的平均疼痛评分和手术时间无显著差异。使用 H Pipelle 进行子宫内膜取样比使用标准 Pipelle 快约 45 秒(平均[标准差]持续时间分别为 1.46[0.72]min 和 2.20[1.19]min,p =.001),但活检充足度相似。大多数女性(两种方法均为 95.5%)认为该手术可接受。无术中或术后并发症。

结论

阴道镜和传统宫腔镜检查在安全性、可行性和相关疼痛方面相似。虽然使用 H Pipelle 获得子宫内膜样本所需的时间比使用标准 Pipelle 快,但总手术时间没有差异。

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