跳至主要内容
临床试验/NCT05381584
NCT05381584Unknown不适用

Balloon Vaginoplasty; Fully Monitored Entry Versus Fractionated Intraumbilical Microports for Treatment of Vaginal-aplasia; A Quasi Randomized Controlled Trial

Assiut University0 个研究点目标入组 60 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
The Operative time

研究概览

简要总结

Vaginal aplasia is a congenital anomaly characterized by congenital absence of the vagina with an incidence approximately 1:4,500-6,000. It carries an emotional, sexual, and social embarrassing effect on those women, The primary aim of treatment is creation of a neo vagina for restoration of the ability for vaginal intercourse. There are several techniques for neo vaginal construction with variable satisfaction rates. Most of these procedures are either invasive and technically demanding or require long duration in a very motivated patient

详细描述

Numerous surgical and nonsurgical procedures with varying degrees of success have been described for correction of the vaginal aplasia, but none have proved to be universally accepted.

Balloon vaginoplasty was first introduced in 2003 by El Saman et al for construction of a naturally lined neo vagina through a laparoscopic.

Technique hosts the triad of a perfect management modality; namely: simplicity, safety and success. The technique acts via mechanical expansion of the vaginal epithelium and underlying tissues at the pre-existing vaginal dimple Being a relatively new modality of management, it went through many refinements to make it much easier and feasible. The cornerstone of refinement always ran around the access to the peritoneal cavity. The latest of which was the fractionated intra umbilical micro ports which have the merits of totally hidden scar at the bottom the umbilicus consequently the best cosmetic outcomes. However, during its insertion process a troublesome partially unmonitored insertion was inevitably observed

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Married Females with vaginal aplasia scheduled for balloon vaginoplasty.

排除标准

  • Females who refused to consent for participation in the study.
  • Unstable marital relationship.

结局指标

主要结局

The Operative time

时间窗: 1 hour

duration of surgery will be calculated from start of laparoscopy

次要结局

未报告次要终点

研究者

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

Alshimaa Hassan Hosney Eeraqi

principal investigator

Assiut University

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