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Outcome and Prognostic Factors of Surgical Management of Scalp AVMs.

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ClinicalTrials.gov Identifier: NCT05341336
Recruitment Status : Recruiting
First Posted : April 22, 2022
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
Antonios Bakheet Henis Soliman, Assiut University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cirsoid Aneurysm Procedure: total surgical excision Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome and Prognostic Factors of Surgical Management of Scalp Arteriovenous Malformations
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Procedure: total surgical excision

patients will be operated under general anesthesia. Pressure is applied along the incision line while staying away from the palpable margin of the AVM lesion and used Raney clips to control bleeding.

Once the skin flap was raised, the lesion could be seen through the galea. The galea around the lesion is incised, and the lesion will be separated from the underlying skin using a combination of bipolar diathermy and sharp dissection.

The nidus is often located in galeal aponeurosis. Dilated arteries and veins extended into subcutaneous tissue, which was separated with special care to prevent accidental nidus rupture and avoid excessive cauterization to prevent postoperative scalp necrosis.

Ligation is applied on feeder arteries, then applied to veins with total excision of the lesion.

After excision of the lesion, the skin flap was replaced with interrupted stitches.

The wound was allowed to heal primarily along with intravenous administration of antibiotics.


Outcome Measures
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Primary Outcome Measures :
  1. Occlusion of the feeding arteries and veins confirmation by imaging techniques [ Time Frame: 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.


  2. Cosmetic outcome according to the modified Hollandar scale [ Time Frame: 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 :
  1. Detect prognostic factors that affect the outcomes: etiology [ Time Frame: 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.


  2. Detect prognostic factors that affect the outcomes: age [ Time Frame: 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.


  3. Detect prognostic factors that affect the outcomes: site and size [ Time Frame: 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.


  4. Detect prognostic factors that affect the outcomes: Primary arterial supply of the AVM, number of feeders [ Time Frame: 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.


  5. Detect prognostic factors that affect the outcomes: clinical symptoms [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05341336


Contacts
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Contact: Mohamed Abdel-Basset Ali Mahmoud Khallaf, Prof 00201006071988 khallaf@aun.edu.eg
Contact: Farrag Mohammad Farrag Saad, M.D. 01065652394 Farragmohammad@aun.edu.eg

Locations
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Egypt
Assiut University Hospitals Recruiting
Assiut, Egypt, 71515
Contact: Mohamed Abdel-Basset Ali Mahmoud Khallaf, Prof    00201006071988    khallaf@aun.edu.eg   
Contact: Farrag Mohammad Farrag Saad, M.D    00201065652394    Farragmohammad@aun.edu.eg   
Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Antonios Bakheet Henis Soliman, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT05341336    
Other Study ID Numbers: OPFSMSAM
First Posted: April 22, 2022    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases