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临床试验/NCT03024242
NCT03024242已完成2 期

Tight Vaginoscopy: a Simplified Novel Technique for a Better Vaginal Surgery

Assiut University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
34
试验地点
2
主要终点
The success rate of the procedure

研究概览

简要总结

Bivalve vaginal speculum insertion is a basic final step of vaginal examination. Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow vagina, women with vaginismus or patients with a history of previous vaginal surgery. In such cases, the value of vaginoscopy (examination of the vagina without speculum) is evident. Indications of vaginoscopy are expanding. In addition to confirmation of suspected vaginal masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal wall in girls due to foreign body , traumatic injuries or sexual abuse. In a systematic review, the effectiveness and feasibility of using hysteroscopy for exploration of the immature genital tract (vaginoscopy) were documented.It may help in the diagnosis and treatment of gynecologic disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow vagina. Another recent systematic review highlighted the importance of Vagino-hysteroscopy as an easy way to gain access to the cervical canal and an important tool with which to diagnose and treat vaginal lesions.

In practice, we notice leakage of excessive irrigating fluid per vagina with poor visualization during vaginoscopy. To the best of our knowledge, no study addressed a solution to improve visualization and success of vaginoscopic surgery. This study aims to test feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy if compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic surgery in patients with vaginal or cervical lesions.

研究设计

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

入排标准

年龄范围
10 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Symptomatizing women with suspected narrow vagina.
  • Nulliparous women or virgin w
  • Vaginal or cervical lesion or foreign body.

排除标准

  • Multiparous women
  • Nulliparous women with patulous or lax vaginae were excluded.

结局指标

主要结局

The success rate of the procedure

时间窗: 20 minutes

次要结局

  • The satisfaction rate by satisfaction score(20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Lecturer

Assiut University

研究点 (2)

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