跳至主要内容
临床试验/NCT07043062
NCT07043062招募中不适用

Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females :ِ A Prospective Comparative Non Randomized Study

South Valley University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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

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

Hassan Elshazly Khodary

Resident at Urology Department, Faculty of Medicine

South Valley University

研究点 (1)

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