Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females :ِ A Prospective Comparative Non Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Treatment of Genitourinary fistula
研究概览
简要总结
Fistula is an abnormal passway that connects two organs or vessels that do not connect normally.
Genitourinary fistula refers to a fistula that occurs between reproductive tract organs (vagina, cervix, and uterus), and lower urinary tract (bladder, urethra, and pelvic ureters).
It is a serious condition which can significantly influence the biological and psychological condition of women, with a negative impact on the quality of life.
详细描述
Fistula is an abnormal passway that connects two organs or vessels that do not connect normally.
Genitourinary fistula refers to a fistula that occurs between reproductive tract organs (vagina, cervix, and uterus), and lower urinary tract (bladder, urethra, and pelvic ureters).
It is a serious condition which can significantly influence the biological and psychological condition of women, with a negative impact on the quality of life.
In developed countries, iatrogenic injury during hysterectomy or pelvic surgery is the primary cause of fistulae . However, the etiology differs in developing countries, being secondary to prolonged, obstructed, complicated labor.
Genitovesical fistulae are one of the most devastating complications in the urogynecology setting. The commonest type of these fistulae is the vesicovaginal fistula (VVF);the patients Suffering from continuous urinary leakage through the vagina and urinary smell, patients with VVF face hygienic, social, infectious, psychological, and sexual problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with Vesicovaginal fistula or Vesicouterine fistula.
- •Timing of repair after 2-6 months of beginning of symptoms and signs of fistula.
排除标准
- •Malignant , Recurrant or Post Radiation Genitovesical fistula.
- •Females with congenital disease in Bladder ,Uterus or Vagina.
- •Females with Vaginal or Uterine prolapse.
研究组 & 干预措施
Group of Laparoscopic Repair
About 25 female patients suffering from Vesicovaginal fistula or Vesicouterine fistula and will be subjected to Laparoscopic repair of the fistula
干预措施: Open surgical Interference (Procedure)
Group of Open Surgical Repair
About 25 female patients suffering from Vesicovaginal fistula or Vesicouterine fistula and will be subjected to surgical repair of the fistula.
干预措施: Open surgical Interference (Procedure)
结局指标
主要结局
Treatment of Genitourinary fistula
时间窗: From base line to 2 Months from the starting of the operation
To examine the female patients whom suffering fromGenitourinary fistula, either by surgical interference or Laparoscopy
次要结局
未报告次要终点
研究者
Hassan Elshazly Khodary
Resident at Urology Department, Faculty of Medicine
South Valley University
