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临床试验/NCT04858919
NCT04858919已完成不适用

Transrectal Ultrasound and 3D Transabdominal Ultrasound in Comparison to Vaginoscopy in Virgins With Suspected Genital Tract Lesions

Ain Shams University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Test performance of different diagnostic modalities in Virgins

研究概览

简要总结

This study is to compare the feasibility and test performance of different 3D pelvic ultrasound and Transrectal ultrasound in the detection of local lesions in the uterus , cervix and vagina compared to the final diagnosis confirmed by vaginoscopy as a golden standard modality of diagnosis in Virgin Patients

详细描述

Virginity is a very private issue; saving or losing it is a matter of choice depending on age, ethnicity, religion, or simply personal decision. Post-pubertal teenage girls, religious women such as nuns, and women in some countries tend to be virgin. This situation must be respected by medical professionals. But when a vaginal examination is necessary, virginity might be a limiting factor for the gynecologist in diagnosis and treatment.

Vaginal discharge or bleeding is the symptom most commonly reported by adolescent girls that are referred for gynecologic problems. The most common cause of vaginal discharge at these ages is infection due to a hypo-estrogenized vagina, although other potential causes, such as congenital anomalies of the genitalia, trauma, foreign bodies, sexual abuse, and malignant disease, must also be excluded. With regard to virginity and childbearing possibility in the future, a careful approach is of paramount importance.

Hymenal tissue does not easily tolerate vigorous manipulation and wide movements. When needed, potential hymeneal disruption may be discussed with mature women or with the parents of adolescent girls for the sake of correct diagnosis and treatment; but in general, they are highly resistant to that.

When a reproductive tract examination or transvaginal operation must be arranged for a virgin, the operator faces a challenge and may hesitate to utilize hysteroscopy, which can result in a delayed diagnosis or improper treatment.

The most common indication for hysteroscopy is abnormal vaginal bleeding in virginal patients and has been widely used for uterine cavity examination and management. Although the possibility of hymen preservation is high, virgins are highly resistant to this procedure. This may be due to a belief that the procedure causes disruption of virginity and worries associated with their future partners.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

The sonographers will be blinded to all images obtained from the initial pelvic ultrasound and from the images obtained by the alternative sonographic modality. Also All sonographic images will be concealed from the physicians performing the vaginoscopy procedure .

入排标准

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

入选标准

  • Virgins complaining of Abnormal vaginal bleeding, abnormal discharge , pelvic pain
  • Virgins with Suspected genital tract lesion by examination
  • Virgins with Suspected genital tract lesion by pelvic ultrasound

排除标准

  • Sexually Active Patients
  • Suspected or documented Pregnancy
  • Virgin patients with no suspected uterine, cervical or vaginal lesion by pelvic ultrasound
  • Patients unable to communicate effectively

结局指标

主要结局

Test performance of different diagnostic modalities in Virgins

时间窗: 24 hours to 1 week

diagnostic accuracy of 3D pelvic ultrasound and Transrectal ultrasound in the detection of local lesions in the uterus, cervix and vagina compared to the final diagnosis confirmed by vaginoscopy as a golden standard modality of diagnosis in Virgins.

Feasibility of different diagnostic modalities in Virgins.

时间窗: 1 to 2 hours

By questionnaire to asses the acceptance of patient to undergo different modalities as 3D pelvic ultrasound, Transrectal ultrasound and vaginoscopy is assessed.

次要结局

  • patients' pain(1-2 hours)
  • Patients' satisfaction(1-2 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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