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临床试验/NCT02705222
NCT02705222已完成不适用

Comparison Between Dilatation and Curettage and Hysteroscopy in Management of Abnormal Uterine Bleeding in Perimenopausal Women

Mohamed Sayed Abdelhafez2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Percentage of abnormal endometrial patterns

研究概览

简要总结

The aim of this study is to compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding and outlining a mode of treatment-specific to the cause.

详细描述

Perimenopausal women complaining of abnormal uterine bleeding will be selected for assessment through detailed history taking, general and abdominal examination, local gynecological examination, transvaginal sonography (TVS) scanning and routine blood investigations. Eligible participants in our study will be those who complain of menorrhagia, metrorrhagia, polymenorrhoea or polymenorrhagia without local gynecological cause with failure of medical treatment for at least 3 months. All women participating in the study will be randomly allocated into two groups; dilatation and curettage (D&C) group and hysteroscopy group. For women in the D&C group, cervical dilatation and fractional endometrial curettage will be done under total intravenous (IV) anesthesia in operation theater and the curetting will be sent for histopathological examination. For women in the hysteroscopy group, hysteroscopy will be done under total IV anesthesia in operation theater hysteroscopic-guided curettings will also be taken and sent for histopathological examination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Perimenopausal women complaining of abnormal uterine bleeding (menorrhagia, metrorrhagia, polymenorrhoea or polymenorrhagia) without local gynecological cause.
  • Failure of medical treatment for at least 3 months.

排除标准

  • Age < 45 or > 55 years.
  • Blood disorders or coagulopathy.
  • Diagnosed or suspected local gynecologic lesion (polyp, adenomyosis, myoma, malignancy or cervical pathology).
  • Use intrauterine contraceptive device.
  • Pregnancy related conditions.

研究组 & 干预措施

D&C group

Active Comparator

Women will undergo D&C

干预措施: D&C (Procedure)

Hysteroscopy group

Active Comparator

Women will undergo hysteroscopy

干预措施: Hysteroscopy (Procedure)

结局指标

主要结局

Percentage of abnormal endometrial patterns

时间窗: One week after the procedure

Number of patients diagnosed to have abnormal endometrial patterns after histopathological examination of the curretings per total number of patients underwent the procedure

次要结局

  • Improvement rate(3 months after the procedure)

研究者

发起方
Mohamed Sayed Abdelhafez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Sayed Abdelhafez

Dr

Mansoura University

研究点 (2)

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