Balloon Vaginoplasty; Fully Monitored Entry Versus Fractionated Intraumbilical Microports for Treatment of Vaginal-aplasia; A Quasi Randomized Controlled Trial
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
- 否
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
Alshimaa Hassan Hosney Eeraqi
principal investigator
Assiut University
