Outcome and Prognostic Factors of Surgical Management of Scalp AVMs.

Not Applicable

Recruiting

• Conditions: Cirsoid Aneurysm
• Interventions: Procedure: total surgical excision

• Registration Number: NCT05341336
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-22
• Study Start: 2022-07-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical excision	total surgical excision	complete surgical excision of the scalp AVMs after identifying feeding arteries, vein and high flew shunts to perform a complete devascularization of the AVM.

Primary Outcome Measures

Name	Time	Method
Occlusion of the feeding arteries and veins confirmation by imaging techniques	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	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.

Secondary Outcome Measures

Name	Time	Method
Detect prognostic factors that affect the outcomes: site and size	This will be monitored for a period of 6 months post-operative.	By identifying the important factors affecting the outcome including: site and size: the site and size of the scalp AVM and how the site affects the prognosis post-operative.
Detect prognostic factors that affect the outcomes: age	This will be monitored for a period of 6 months post-operative.	By identifying the important factors affecting the outcome including: age Studying how age variation can affect the outcome of surgical excision of scalp AVMs and compare different age groups to prognosis.
Detect prognostic factors that affect the outcomes: clinical symptoms	This will be monitored for a period of 6 months post-operative.	By identifying the important factors affecting the outcome including: clinical symptoms: how pre-operative symptoms could be indicative for prognosis compared to post-operative symptoms in case of any residuals.; Studying various symptoms compared with post-operative residuals, if any, and how they can affect the outcome of surgical excision of scalp AVMs.
Detect prognostic factors that affect the outcomes: etiology	This will be monitored for a period of 6 months post-operative.	By identifying the important factors affecting the outcome including: etiology: congenital, traumatic or idiopathic. Studying how etiology can affect the outcome of surgical excision of scalp AVMs.
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.	By identifying the important factors affecting the outcome including: Primary arterial supply of the AVM, number of feeders: through the use of imaging techniques, determine the primary feeding arteries and their numbers and hw it will affect the prognosis and recurrence rate.; Studying the distribution of the AVMs and their primary arterial supply and the number of feeding arteries and how this can affect the outcome of surgical excision of scalp AVMs.; based on the anatomy of arterial supply.

Trial Locations

Locations (1)

Assiut University Hospitals; 🇪🇬 Assiut, Egypt