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临床试验/NCT06405698
NCT06405698尚未招募不适用

A Randomized Comparison Between Perforator Flap vs Perforator Plus Flap in Myelomeningocele Defect Repair

Assiut University0 个研究点目标入组 30 人开始时间: 2024年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
changing hospital stay time

研究概览

简要总结

evaluation of perforator flaps versus perforator plus flaps

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
2 Days 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

changing hospital stay time

时间窗: baseline and one month

changing complication rate

时间窗: baseline and 3 months

evaluate of different flaps modalities in back defects closure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed elsayed tawfik

assistant lecturer

Assiut University

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