Bladder ExstrophyNCT06717386
Pelvic Osteotomy in Bladder Exstrophy
A study testing diagonal pelvic osteotomy in people with Bladder Exstrophy, run by Sohag University at 1 site in Egypt.
Trial summary
The study focuses on the surgical treatment of bladder exstrophy, a congenital condition where the bladder is located outside the body. It examines the use of modified diagonal pelvic osteotomy combined with an external fixator as a treatment approach. Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Exstrophy
- What is being tested?
- diagonal pelvic osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2024to 2 Feb 2026
- Phase
- Interventional
- 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 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age: all cases of delayed exstrophy repaior
- sex : both gender
- children who received no operative treatment befor
Who cannot join
- previous pelvic surgery
- sever comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University
Sohag
Ali Bakheet, assistant lecturer, 02001010505552, ali.mohamed@med.sohag.edu.eg
About this study
Official title: Modified Diagonal Pelvic Osteotomy and External Fixator in the Surgical Treatment of Bladder Exstrophy
The study focuses on the surgical treatment of bladder exstrophy, a congenital condition where the bladder is located outside the body. It examines the use of modified diagonal pelvic osteotomy combined with an external fixator as a treatment approach. This method aims to improve pelvic support and facilitate proper bladder reconstruction. The study likely evaluates the outcomes, complications, and overall effectiveness of this surgical technique in enhancing patient quality of life and functional results. Key findings may include insights into recovery times, rates of successful bladder closure, and potential long-term benefits for patients.
- Conditions
- Bladder Exstrophy
- Being tested
- diagonal pelvic osteotomy
- Medical subject headings
- Bladder Exstrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagonal pelvic osteotomyProcedure or surgery
supraacetabular pelvic osteotomy in oblique shape
| Study group | Role | What they receive |
|---|---|---|
| bladder epithpidius complex | Other | diagonal pelvic osteotomy in bladder exstrophy Receives: Procedure: diagonal pelvic osteotomy |
| bladder exstrophy | Other | horizontal pelvic osteotomy Receives: Procedure: diagonal pelvic osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
symphyseal diastaisis
radiological
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start2 Dec 2024 (estimated)
- Primary completion2 Dec 2025 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder ExstrophyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Abdelaal Bakheet, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717386
- Sponsor's protocol ID
- Soh-Med-24-11-1MD
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Diagonal Pelvic Osteotomy and External Fixator in the Surgical Treatment of Bladder Exstrophy
- ClinicalTrials.gov ID
- NCT06717386
- Acronym / sponsor ID
- Soh-Med-24-11-1MD
- Conditions
- Bladder Exstrophy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Dec 2024 (estimated)
- Primary completion
- 2 Dec 2025 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 5 Dec 2024 (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 study focuses on the surgical treatment of bladder exstrophy, a congenital condition where the bladder is located outside the body. It examines the use of modified diagonal pelvic osteotomy combined with an external fixator as a treatment approach. This method aims to improve pelvic support and facilitate proper bladder reconstruction. The study likely evaluates the outcomes, complications, and overall effectiveness of this surgical technique in enhancing patient quality of life and functional results. Key findings may include insights into recovery times, rates of successful bladder closure, and potential long-term benefits for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bladder epithpidius complex | Other | Procedure: diagonal pelvic osteotomydiagonal pelvic osteotomy in bladder exstrophy |
| bladder exstrophy | Other | Procedure: diagonal pelvic osteotomyhorizontal pelvic osteotomy |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age: all cases of delayed exstrophy repaior
- sex : both gender
- children who received no operative treatment befor
Key exclusion criteria (2 listed)
- previous pelvic surgery
- sever comorbidities
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 |
|---|---|---|
| diagonal pelvic osteotomysupraacetabular pelvic osteotomy in oblique shape | Procedure or surgery | bladder epithpidius complex, bladder exstrophy |
Primary outcome
symphyseal diastaisis
Time frame: 1 year
radiological
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 5 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagonal pelvic osteotomy in people with Bladder Exstrophy, run by Sohag 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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 5 Dec 2024. 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?
Contact Ali abdel aal Bakheet, assistant lecturer (02001010505552, ali.mohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symphyseal diastaisis (time frame: 1 year). 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 5 Dec 2024.