Role of Perforator Flaps in Back Defects Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Myelomeningocele
• Interventions: Procedure: surgical closure of myelomeningocele defects by perforator-plus flaps; Procedure: surgical closure of myelomeningocele defects by perforator flaps

• Registration Number: NCT06405698
• Lead Sponsor: Assiut University

Brief Summary

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 Timeline

• Study First Submitted: 2024-04-29
• Status Verified: 2024-05
• Study Start: 2024-05
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-11
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• infants up to one year,
• dorso-lumbar myelomeningocele.
• moderate to large myelomeningocele defects. (25 - 39 cm2 ) .

Exclusion Criteria

• cervical myelomeningocele
• very large defects (more than 40 cm2 )
• preterm newborn patients.
• hematological disease
• any problem against prone position of the patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
closure of the myelomeningocele defect by perforator plus flap .	surgical closure of myelomeningocele defects by perforator-plus flaps	fifteen patient with myelomeningocele defect
closure of the myelomeningocele defect by perforator flap.	surgical closure of myelomeningocele defects by perforator flaps	fifteen patient with myelomeningocele defect

Primary Outcome Measures

Name	Time	Method
changing hospital stay time	baseline and one month
changing complication rate	baseline and 3 months	evaluate of different flaps modalities in back defects closure