Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females

South Valley University

Status: Enrolling

Conditions: Genitovesical Fistula

Treatments: Procedure: Open surgical Interference

Study type: Interventional

Funder types: Other

Identifiers

NCT07043062

Female Genitovesical fistula

Details and patient eligibility

About

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.

Full description

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.

Vesicouterine fistulae (VUF) are not as common as VVF. In 1908, the first case was reported by Knipe , and later in 1957, Youssef reported on the classic symptoms of VUF. These symptoms included amenorrhea and cyclic hematuria, or menouria; known afterward as Youssef's syndrome. The prevalence of these fistulae is estimated to be 1-4% of all genitourinary fistulae.

Several options for the management of such fistulae have been discussed; these include conservative treatment with prolonged catheterization , open surgery, cysto-fulguration, endourology, and laparoscopy/robotic surgery. The decision-making is guided by the patient characteristics, etiology, and the experience of the treating surgeon.

Laparoscopy is of great advantage when compared to open surgery, including safe, effective, minimally invasive procedure, less postoperative pain, smaller incisions, lower blood loss, a shorter hospital stay, and faster recovery. It is associated with a lower incidence of postoperative complications, including infections and improper wound healing

Enrollment: 50 estimated patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females with Vesicovaginal fistula or Vesicouterine fistula.
• Timing of repair after 2-6 months of beginning of symptoms and signs of fistula.

Exclusion criteria

• Malignant , Recurrant or Post Radiation Genitovesical fistula.
• Females with congenital disease in Bladder ,Uterus or Vagina.
• Females with Vaginal or Uterine prolapse.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group of Laparoscopic Repair

Active Comparator group

Description:

About 25 female patients suffering from Vesicovaginal fistula or Vesicouterine fistula and will be subjected to Laparoscopic repair of the fistula

Treatment:

Procedure: Open surgical Interference

Group of Open Surgical Repair

Active Comparator group

Description:

About 25 female patients suffering from Vesicovaginal fistula or Vesicouterine fistula and will be subjected to surgical repair of the fistula.

Treatment:

Procedure: Open surgical Interference