Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females

NCT ID: NCT07043062

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Genitovesical Fistula

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Open surgical Interference

Intervention Type PROCEDURE

to compare the outcomes of Laparoscopic repair versus Open surgical repair of Genitovesical fistula in females.

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.

Group Type ACTIVE_COMPARATOR

Open surgical Interference

Intervention Type PROCEDURE

to compare the outcomes of Laparoscopic repair versus Open surgical repair of Genitovesical fistula in females.

Interventions

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Open surgical Interference

to compare the outcomes of Laparoscopic repair versus Open surgical repair of Genitovesical fistula in females.

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic Repair

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Hassan Elshazly Khodary

Resident at Urology Department, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Aboalyosr Mohamed, Professor

Role: STUDY_CHAIR

Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt

Locations

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South Valley University Hospital

Qina, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hassan Elshazly Khodary Hassanein, MSC

Role: CONTACT

+201006769357

Ahmed Mahmoud Hassan, Assist.prof

Role: CONTACT

+201069611961

Facility Contacts

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Mostafa AbdelRazek Ahmed, Assist.Prof

Role: primary

+201004116386

Other Identifiers

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Female Genitovesical fistula

Identifier Type: -

Identifier Source: org_study_id

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