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临床试验/NCT05341336
NCT05341336招募中不适用

Outcome and Prognostic Factors of Surgical Management of Scalp Arteriovenous Malformations

Assiut University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Occlusion of the feeding arteries and veins confirmation by imaging techniques

研究概览

简要总结

Scalp arteriovenous malformations (AVMs) are rarely encountered vascular scalp anomalies that represent 8% of all AVMs. Different terms are being used to describe the vascular anomalies of the scalp include cirsoid aneurysm, racemosum aneurysm, plexiform angioma, arteriovenous fistula and arteriovenous malformation. Derived from the Greek language, kirsos, the term cirsoid aneurysm is used to describe the AVM as it resembles varix. Case studies reported approximately 200 cases with increased prevalence during the last 15 years. The etiology of scalp AVMs remains controversial, it can be spontaneous or traumatic. They generally develop in the trauma background and in patients over 30-year-old while spontaneous scalp AVM may present at birth and remains asymptomatic until adulthood.

详细描述

Patients with scalp AVMs are usually presented with scalp swelling, and cosmetic concerns along with other presentations including headache, pain, tinnitus, audible bruits, palpable thrills, and hemorrhage. Neuro-radiological diagnosis is the cornerstone for the surgical procedure to be performed, and cranial angiography is of great significance for diagnosis and treatment selection. MRA is also of significance for establishing a diagnosis as scalp AVMs are confused with hemangioma and cavernomas. Treatment of the cirsoid aneurysm is difficult due to the abnormal fistulous communications between the feeding arteries and veins and high shunt flow. Management protocols for scalp AVMs include various options including surgical excision, endovascular embolization, ligation, and intralesional injections. Operative blood loss, postoperative cosmetic complications are significant concerns when treating scalp AVMs, thus various methods are used pre and postoperatively in order to control these concerns. A thorough analysis of scalp AVMs regarding anatomy, feeder vessels, size, and other different variables is required for a better understanding of the problem in order to improve the outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with scalp AVMs confirmed by various imaging techniques. AVMs of the scalp will include: cirsoid aneurysm, serpentinum aneurysm, racemosum aneurysm, plexiform angioma, arteriovenous fistula, high flow shunts and arteriovenous malformations.
  • Age group: any age group.
  • Aetiology: congenital, traumatic, or any.

排除标准

  • High risk patients or unfit for surgery.
  • Patients refused surgery, or scheduled for endovascular intervention.

结局指标

主要结局

Occlusion of the feeding arteries and veins confirmation by imaging techniques

时间窗: This will be monitored for a period of 6 months post-operative.

identifying the occluded arteries and vein of the excised AVM through the use of diagnostic radiology including CT angiography and conventional angiography to evaluate the results of a well planned surgical excision of scalp AVM. This will be monitored for a period of 6 months post operative.

Cosmetic outcome according to the modified Hollandar scale

时间窗: This will be monitored for a period of 6 months post-operative.

Following up the cosmetic outcome according to the modified Hollandar scale to achieve better prognosis and higher patient satisfaction. The modified Hollandar scale: 0 score represents the best score, and an overall score of 6 points represents the worst outcome. the use of the modified Hollander scale would be used for post-operative evaluation and a period of 6 month-follow-up.

次要结局

  • Detect prognostic factors that affect the outcomes: site and size(This will be monitored for a period of 6 months post-operative.)
  • Detect prognostic factors that affect the outcomes: age(This will be monitored for a period of 6 months post-operative.)
  • Detect prognostic factors that affect the outcomes: clinical symptoms(This will be monitored for a period of 6 months post-operative.)
  • Detect prognostic factors that affect the outcomes: etiology(This will be monitored for a period of 6 months post-operative.)
  • Detect prognostic factors that affect the outcomes: Primary arterial supply of the AVM, number of feeders(This will be monitored for a period of 6 months post-operative.)

研究者

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

Antonios Bakheet Henis Soliman

Principal Investigator

Assiut University

研究点 (2)

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