Prune Belly SyndromeNCT06928974
Functional Abdominal Wall Reconstruction
An observational study of Prune Belly Syndrome, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
Assessement of outcomes of functional reconstruction of underdeveloped abdominal muscles with the use od pedicled Vastus Lateralis Muscle flaps. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Prune Belly Syndrome
- What is being tested?
- Bilateral Pedicled Vastus Lateralis Muscle Flaps Transposition
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2017to 30 Sep 2026
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients diagnosed with Prune Belly syndrome suffering from symptoms related to abdominal wall insufficiency
Who may be able to join
- Patients diagnoes with Prune Belly Syndrome
- severe underdevelopment of rectus abdomini muscles
- patients who underwent microsurgical bipedicled vastus lateralis muscle flaps transposition
- patient undery 18 y.o.
Who cannot join
- Patient over the age of 18
- Patients who did not agreed for proposed microsurgical reconstruction of the abdominal wall
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Abdominal Wall Reconstruction in Patients With Prune Belly Syndrome
Assessement of outcomes of functional reconstruction of underdeveloped abdominal muscles with the use od pedicled Vastus Lateralis Muscle flaps.
- Conditions
- Prune Belly Syndrome
- Being tested
- Bilateral Pedicled Vastus Lateralis Muscle Flaps Transposition
- Medical subject headings
- Prune Belly Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Pedicled Vastus Lateralis Muscle Flaps TranspositionProcedure or surgery
Bilateral Pedicled Vastus Lateralis Muscle Flaps Transposition to restore the function of underdeveloped or absent rectus abdomini muscles
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography
To assess the proper function of transposed muscles the electromyographic tests were used to assess the proper electroactivity of transposed vastus lateralis muscles. The measured values of amplitude (mV) and conduction velocity(ms) were analyzed.
Measured: followup reached 96months
Motor tests - performance of ''sit-up''-like movement
Patients were asked to perform situp-like movement with legs fasetned before surgical transposition of muscles and then 12 months postoperatively. It was assessed in 0/1 manner. 0 - patient not able to do the sit-up, 1 - patient able to do the sit-up
Measured: Followup reached 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Jan 2017
- Primary completion1 Mar 2024
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prune Belly SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Górnośląskie Centrum Zdrowia Dziecka
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928974
- Sponsor's protocol ID
- 2017/01/01GCZD
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopes RI, Baker LA, Denes FT. Modern management of and update on prune belly syndrome. J Pediatr Urol. 2021 Aug;17(4):548-554. doi: 10.1016/j.jpurol.2021.04.010. Epub 2021 Apr 24.
PubMed 34016542
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Abdominal Wall Reconstruction in Patients With Prune Belly Syndrome
- ClinicalTrials.gov ID
- NCT06928974
- Acronym / sponsor ID
- 2017/01/01GCZD
- Conditions
- Prune Belly Syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Górnośląskie Centrum Zdrowia Dziecka
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Apr 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.
Assessement of outcomes of functional reconstruction of underdeveloped abdominal muscles with the use od pedicled Vastus Lateralis Muscle flaps.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients diagnosed with Prune Belly syndrome suffering from symptoms related to abdominal wall insufficiency
Key inclusion criteria (4 listed)
- Patients diagnoes with Prune Belly Syndrome
- severe underdevelopment of rectus abdomini muscles
- patients who underwent microsurgical bipedicled vastus lateralis muscle flaps transposition
- patient undery 18 y.o.
Key exclusion criteria (3 listed)
- Patient over the age of 18
- Patients who did not agreed for proposed microsurgical reconstruction of the abdominal wall
- -
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 |
|---|---|---|
| Bilateral Pedicled Vastus Lateralis Muscle Flaps TranspositionBilateral Pedicled Vastus Lateralis Muscle Flaps Transposition to restore the function of underdeveloped or absent rectus abdomini muscles | Procedure or surgery | – |
Primary outcome
Electromyography
Time frame: followup reached 96months
To assess the proper function of transposed muscles the electromyographic tests were used to assess the proper electroactivity of transposed vastus lateralis muscles. The measured values of amplitude (mV) and conduction velocity(ms) were analyzed.
Motor tests - performance of ''sit-up''-like movement
Time frame: Followup reached 96 months
Patients were asked to perform situp-like movement with legs fasetned before surgical transposition of muscles and then 12 months postoperatively. It was assessed in 0/1 manner. 0 - patient not able to do the sit-up, 1 - patient able to do the sit-up
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 15 Apr 2025.
- Background: PubMed 34016542Lopes RI, Baker LA, Denes FT. Modern management of and update on prune belly syndrome. J Pediatr Urol. 2021 Aug;17(4):548-554. doi: 10.1016/j.jpurol.2021.04.010. Epub 2021 Apr 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Prune Belly Syndrome, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 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 Poland. 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?
Electromyography (time frame: followup reached 96months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06928974, which also lists 1 linked publication.
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 15 Apr 2025.