Success of OperationNCT06803160
Comparative Study of Laparoscopic Combined Trans-vesical and Extravesical Versus Laparoscopic Extravesical Fistula Excision in Uterovesical Fistula Repair: A Retrospective Observational Study
An observational study of Success of Operation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare between laparoscopic combined trans-vesical and extravesical versus laparoscopic extravesical fistula excision in uterovesical fistula repair. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Success of Operation
- What is being tested?
- Laparoscopic Extravesical Fistula Excision of Uterovesical Fistula and Laparoscopic Combined Fistula Excision of Uterovesical Fistula
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2025to 28 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
- The aim of this study is to compare between laparoscopic combined trans-vesical and extravesical versus laparoscopic extravesical fistula excision in uterovesical fistula repair.
- Conditions
- Success of Operation
- Being tested
- Laparoscopic Extravesical Fistula Excision of Uterovesical Fistula, Laparoscopic Combined Fistula Excision of Uterovesical Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Extravesical Fistula Excision of Uterovesical FistulaProcedure or surgery
- 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.
Laparoscopic Combined Fistula Excision of Uterovesical FistulaProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Combined Fistula Excision of Uterovesical Fistula | Patinets who underwent Laparoscopic Combined Fistula Excision of Uterovesical Fistula Receives: Procedure: Laparoscopic Extravesical Fistula Excision of Uterovesical Fistula; Procedure: Laparoscopic Combined Fistula Excision of Uterovesical Fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of operation
Success of operation with excision of fistula in upcoming CT cystogram
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start30 Jan 2025 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Success of OperationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hossam, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803160
- Sponsor's protocol ID
- Lap Uterovesical Fistula
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Laparoscopic Combined Trans-vesical and Extravesical Versus Laparoscopic Extravesical Fistula Excision in Uterovesical Fistula Repair: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06803160
- Acronym / sponsor ID
- Lap Uterovesical Fistula
- Conditions
- Success of Operation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Combined Fistula Excision of Uterovesical Fistula | – | Procedure: Laparoscopic Extravesical Fistula Excision of Uterovesical Fistula, Procedure: Laparoscopic Combined Fistula Excision of Uterovesical FistulaPatinets who underwent Laparoscopic Combined Fistula Excision of Uterovesical Fistula |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- • Pregnant females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Laparoscopic Combined Fistula Excision of Uterovesical Fistula |
| 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. | Procedure or surgery | Laparoscopic Combined Fistula Excision of Uterovesical Fistula |
Primary outcome
success of operation
Time frame: 6 months
Success of operation with excision of fistula in upcoming CT cystogram
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Success of Operation, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of operation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.