Comparative Study of Laparoscopic Combined Trans-vesical and Extravesical Versus Laparoscopic Extravesical Fistula Excision in Uterovesical Fistula Repair: A Retrospective Observational Study

January 26, 2025 updated by: Mahmoud Hossam, Ain Shams University
• The aim of this study is to compare between laparoscopic combined trans-vesical and extravesical versus laparoscopic extravesical fistula excision in uterovesical fistula repair.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11865
        • Ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • This is a retrospective study involving the retrieval and analysis of medical records of uterovesical patients who were managed at the Urology and Gynecology departments at Ain Shams University Hospitals.

  • Patient's records that were included in the study satisfied the following criteria:

    • The patient was diagnosed with uterovesical fistula.
    • The patient had laparoscopic surgery with either approach at the Urology and Gynecology departments at Ain Shams University Hospitals.
    • The fistulous track was confirmed and had been repaired.

Description

Inclusion Criteria:

Patients diagnosed with uterovesical fistula with history of uterine cesarean section or any urogenital surgery complaining of amenorrhea, cyclic hematuria, with or without urinary incontinence.

Exclusion Criteria:

  • • Pregnant females.

    • Patients who refuse to participate in the study.
    • Patients with concomitant pathology that could affect symptoms e.g., polycystic ovary disease, stress incontinence, bladder cancer or overactive bladder.
    • Patients with malignant fistula.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Laparoscopic Combined Fistula Excision of Uterovesical Fistula
Patinets who underwent Laparoscopic Combined Fistula Excision of Uterovesical Fistula
Procedure: Laparoscopic Extravesical Fistula Excision of Uterovesical Fistula
• In extravesical approach, the posterior bladder wall and the anterior uterine wall around the fistula will be dissected. Scar tissue around the orifice of the fistula will be removed and trimmed. After suturing uterine and bladder wall, intervening omentum will be placed in-between.
Procedure: Laparoscopic Combined Fistula Excision of Uterovesical Fistula
• In the combined approach, bladder will be opened bivalved till the site of the fistula. Scar tissue around the orifice of the fistula will be removed and trimmed. Careful dissection around the bladder and uterus will be done to suture both walls and place an intervening omentum in-between.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success of operation
Time Frame: 6 months
Success of operation with excision of fistula in upcoming CT cystogram
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2025

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

January 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lap Uterovesical Fistula

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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