Laparoscopic versus open repair for genitovesical fistula in women
Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females :ِ A Prospective Comparative Non Randomized Study
This study will test whether laparoscopic or open surgery works better to repair genitovesical fistulas in women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 25 Years to 70 Years |
| Sex | Female |
| Sponsor | South Valley University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Qina) |
| Trial ID | NCT07043062 on ClinicalTrials.gov |
What this trial studies
This interventional study compares two surgical approaches—laparoscopic and open repair—for genitovesical fistula in female patients. Eligible women typically present 2–6 months after symptom onset and undergo one of the two surgical procedures at the enrolling center. The trial excludes malignant, recurrent, or post-radiation fistula and patients with congenital pelvic anomalies or prolapse, with outcomes focused on fistula closure, complications, and recovery. Procedures and follow-up are conducted at South Valley University Hospital with standardized perioperative care.
Who should consider this trial
Good fit: Women with vesicovaginal or vesicouterine fistula who present 2–6 months after symptom onset and do not have prior radiation, recurrent disease, or congenital pelvic anomalies.
Not a fit: Patients with malignant, recurrent, or post-radiation genitovesical fistula, congenital bladder/uterine/vaginal abnormalities, or significant vaginal/uterine prolapse are excluded and unlikely to benefit from the procedures tested here.
Why it matters
Potential benefit: If one approach proves superior, patients could experience higher rates of fistula closure, fewer complications, and faster recovery.
How similar studies have performed: Open surgical repair is an established treatment and case series report that laparoscopic repair can be effective, but randomized comparative data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Qina
- South Valley University Hospital — Qina, Egypt (Recruiting)
Study contacts
- Study coordinator: Hassan Elshazly Khodary Hassanein, MSC
- Email: hassanelshazly67@gmail.com
- Phone: +201006769357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.