MyelomeningoceleNCT06405698
Role of Perforator Flaps in Back Defects Reconstruction
A study testing surgical closure of myelomeningocele defects by perforator flaps and surgical closure of myelomeningocele defects by perforator-plus flaps in people with Myelomeningocele, run by Assiut University.
Trial summary
evaluation of perforator flaps versus perforator plus flaps Read more about this study
- Who is it for?
- Ages 2 days to 1 year
- Conditions the study is for
- Myelomeningocele
- What is being tested?
- surgical closure of myelomeningocele defects by perforator flaps and surgical closure of myelomeningocele defects by perforator-plus flaps
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 days to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants up to one year,
- dorso-lumbar myelomeningocele.
- moderate to large myelomeningocele defects. (25 - 39 cm2 ) .
Who cannot join
- cervical myelomeningocele
- very large defects (more than 40 cm2 )
- preterm newborn patients.
- hematological disease
- any problem against prone position of the patient
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Comparison Between Perforator Flap vs Perforator Plus Flap in Myelomeningocele Defect Repair
evaluation of perforator flaps versus perforator plus flaps
Read the detailed description
One of the neural tube defects, myelomeningocele, is a congenital anomaly developing in the fourth gestational week. It is characterized by insertion of neural elements into a pouch floored by meninx through a vertebral defect.
The aetiology is multifactorial. causes are genetic properties, geographic factors, and deficiency of folic acid.
Meningomyelocele incidence range between 1 and 2/1000 live births. The defect location can reside anywhere between the cervical region and the sacrum.
surgical closure of the defect is performed to prevent cerebrospinal fluid leakage and central nervous system infections. it is a combined work between neurosurgery and plastic surgery. Fascial turnover flaps, muscle flaps, local fasciocutaneous flaps.
With the emerging concepts of perforator flaps in the last three decades, the reconstruction of myelomeningocele defects has completely changed since the anatomy of the dorsal intercostal artery perforators (DIAP) and lumbar artery perforators(LAP) has been fully studied.
Despite utilizing perforator flaps having greatly improved the outcome of myelomeningocele reconstruction, venous compromise remained a major concern associated with complications.
By preserving, the perforator vessels and minimizing the amount of tissue that is removed, the Perforator Plus technique can improve blood flow and decrease the risk of venous congestion.
Preoperative perforator mapping may be executed by a multitude of diagnostic modalities. Hand-held Doppler (HHD), color-coded duplex sonography (CCDS), computed tomography angiography (CTA), magnetic resonance angiography (MRA) and others may be applied.
Systematic reviews of the literature revealed that CCDS has the highest sensitivity and positive predictive value to identify perforators for flaps.
- Conditions
- Myelomeningocele
- Being tested
- surgical closure of myelomeningocele defects by perforator flaps, surgical closure of myelomeningocele defects by perforator-plus flaps
- Keywords
- myelomeningocele, perforator flaps, infants
- Medical subject headings
- Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical closure of myelomeningocele defects by perforator flapsProcedure or surgery
closure of myelomeningocele defect by perforator island flap after complete incision of the flap all around based on perforator vessel .
surgical closure of myelomeningocele defects by perforator-plus flapsProcedure or surgery
closure of myelomeningocele defect by perforator-plus island flap harvesting leaving skin bridge connecting to the flap and dissection of the perforator vessel
| Study group | Role | What they receive |
|---|---|---|
| closure of the myelomeningocele defect by perforator flap. | Experimental | fifteen patient with myelomeningocele defect Receives: Procedure: surgical closure of myelomeningocele defects by perforator flaps |
| closure of the myelomeningocele defect by perforator plus flap . | Experimental | fifteen patient with myelomeningocele defect Receives: Procedure: surgical closure of myelomeningocele defects by perforator-plus flaps |
What is being measured
The primary outcome is the main question the study is designed to answer.
changing complication rate
evaluate of different flaps modalities in back defects closure
Measured: baseline and 3 months
changing hospital stay time
Measured: baseline and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study startMay 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MyelomeningoceleStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed elsayed tawfik, Assiut University
- Investigators
- mahmoud Abdelaal, doctor, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405698
- Sponsor's protocol ID
- flaps in myelomeningiocele
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Isik D, Tekes L, Eseoglu M, Isik Y, Bilici S, Atik B. Closure of large myelomeningocele defects using dorsal intercostal artery perforator flap. Ann Plast Surg. 2011 Aug;67(2):159-63. doi: 10.1097/SAP.0b013e3181f3e0cf.
PubMed 21301309Cologlu H, Ozkan B, Uysal AC, Cologlu O, Borman H. Bilateral propeller flap closure of large meningomyelocele defects. Ann Plast Surg. 2014 Jul;73(1):68-73. doi: 10.1097/SAP.0b013e31826caf5a.
PubMed 24918736Basterzi Y, Tenekeci G. Dorsal Intercostal Artery Perforator Propeller Flaps: A Reliable Option in Reconstruction of Large Meningomyelocele Defects. Ann Plast Surg. 2016 Apr;76(4):434-7. doi: 10.1097/SAP.0000000000000417.
PubMed 26010351Kehrer A, Heidekrueger PI, Lonic D, Taeger CD, Klein S, Lamby P, Sachanadani NS, Jung EM, Prantl L, Batista da Silva NP. High-Resolution Ultrasound-Guided Perforator Mapping and Characterization by the Microsurgeon in Lower Limb Reconstruction. J Reconstr Microsurg. 2021 Jan;37(1):75-82. doi: 10.1055/s-0040-1702162. Epub 2020 Feb 28.
PubMed 32110822
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between Perforator Flap vs Perforator Plus Flap in Myelomeningocele Defect Repair
- ClinicalTrials.gov ID
- NCT06405698
- Acronym / sponsor ID
- flaps in myelomeningiocele
- Conditions
- Myelomeningocele
- Keywords
- myelomeningocele, perforator flaps, infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 8 May 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.
evaluation of perforator flaps versus perforator plus flaps
Detailed description
One of the neural tube defects, myelomeningocele, is a congenital anomaly developing in the fourth gestational week. It is characterized by insertion of neural elements into a pouch floored by meninx through a vertebral defect.
The aetiology is multifactorial. causes are genetic properties, geographic factors, and deficiency of folic acid.
Meningomyelocele incidence range between 1 and 2/1000 live births. The defect location can reside anywhere between the cervical region and the sacrum.
surgical closure of the defect is performed to prevent cerebrospinal fluid leakage and central nervous system infections. it is a combined work between neurosurgery and plastic surgery. Fascial turnover flaps, muscle flaps, local fasciocutaneous flaps.
With the emerging concepts of perforator flaps in the last three decades, the reconstruction of myelomeningocele defects has completely changed since the anatomy of the dorsal intercostal artery perforators (DIAP) and lumbar artery perforators(LAP) has been fully studied.
Despite utilizing perforator flaps having greatly improved the outcome of myelomeningocele reconstruction, venous compromise remained a major concern associated with complications.
By preserving, the perforator vessels and minimizing the amount of tissue that is removed, the Perforator Plus technique can improve blood flow and decrease the risk of venous congestion.
Preoperative perforator mapping may be executed by a multitude of diagnostic modalities. Hand-held Doppler (HHD), color-coded duplex sonography (CCDS), computed tomography angiography (CTA), magnetic resonance angiography (MRA) and others may be applied.
Systematic reviews of the literature revealed that CCDS has the highest sensitivity and positive predictive value to identify perforators for flaps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| closure of the myelomeningocele defect by perforator flap. | Experimental | Procedure: surgical closure of myelomeningocele defects by perforator flapsfifteen patient with myelomeningocele defect |
| closure of the myelomeningocele defect by perforator plus flap . | Experimental | Procedure: surgical closure of myelomeningocele defects by perforator-plus flapsfifteen patient with myelomeningocele defect |
Who may qualify
- Ages
- 2 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- infants up to one year,
- dorso-lumbar myelomeningocele.
- moderate to large myelomeningocele defects. (25 - 39 cm2 ) .
Key exclusion criteria (5 listed)
- cervical myelomeningocele
- very large defects (more than 40 cm2 )
- preterm newborn patients.
- hematological disease
- any problem against prone position of the patient
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 |
|---|---|---|
| surgical closure of myelomeningocele defects by perforator flapsclosure of myelomeningocele defect by perforator island flap after complete incision of the flap all around based on perforator vessel . | Procedure or surgery | closure of the myelomeningocele defect by perforator flap. |
| surgical closure of myelomeningocele defects by perforator-plus flapsclosure of myelomeningocele defect by perforator-plus island flap harvesting leaving skin bridge connecting to the flap and dissection of the perforator vessel | Procedure or surgery | closure of the myelomeningocele defect by perforator plus flap . |
Primary outcome
changing complication rate
Time frame: baseline and 3 months
evaluate of different flaps modalities in back defects closure
changing hospital stay time
Time frame: baseline and one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 21301309Isik D, Tekes L, Eseoglu M, Isik Y, Bilici S, Atik B. Closure of large myelomeningocele defects using dorsal intercostal artery perforator flap. Ann Plast Surg. 2011 Aug;67(2):159-63. doi: 10.1097/SAP.0b013e3181f3e0cf.
- Background: PubMed 24918736Cologlu H, Ozkan B, Uysal AC, Cologlu O, Borman H. Bilateral propeller flap closure of large meningomyelocele defects. Ann Plast Surg. 2014 Jul;73(1):68-73. doi: 10.1097/SAP.0b013e31826caf5a.
- Background: PubMed 26010351Basterzi Y, Tenekeci G. Dorsal Intercostal Artery Perforator Propeller Flaps: A Reliable Option in Reconstruction of Large Meningomyelocele Defects. Ann Plast Surg. 2016 Apr;76(4):434-7. doi: 10.1097/SAP.0000000000000417.
- Background: PubMed 32110822Kehrer A, Heidekrueger PI, Lonic D, Taeger CD, Klein S, Lamby P, Sachanadani NS, Jung EM, Prantl L, Batista da Silva NP. High-Resolution Ultrasound-Guided Perforator Mapping and Characterization by the Microsurgeon in Lower Limb Reconstruction. J Reconstr Microsurg. 2021 Jan;37(1):75-82. doi: 10.1055/s-0040-1702162. Epub 2020 Feb 28.
- Individual participant dataSharing planned: No
Related trials for Myelomeningocele
Active, not recruitingPhase 1
Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study
Neural Tube Defects
Recruiting
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
Spina Bifida
Recruiting
tSCS in Children With Spina Bifida
Spina Bifida, Myelomeningocele
Active, not recruiting
Fetoscopic NEOX Cord 1K® Spina Bifida Repair
Spina Bifida, Myelomeningocele
Enrolling by invitation
Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges
Cerebral Palsy, Myelomeningocele
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.
mahmoud Abdelaal, doctor study director
professor
Questions about this trial
What is this clinical trial studying?
A study testing surgical closure of myelomeningocele defects by perforator flaps and surgical closure of myelomeningocele defects by perforator-plus flaps in people with Myelomeningocele, run by Assiut University.
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 5 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed tawfik, doctor (01029980167, mtawfik206@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changing complication rate (time frame: baseline and 3 months). 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 NCT06405698, which also lists 4 linked publications.
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 8 May 2024.