Outcome and Prognostic Factors of Surgical Management of Scalp AVMs.
Primary Purpose
Cirsoid Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
total surgical excision
Sponsored by
About this trial
This is an interventional treatment trial for Cirsoid Aneurysm
Eligibility 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.
Sites / Locations
- Assiut University HospitalsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgical excision
Arm Description
complete surgical excision of the scalp AVMs after identifying feeding arteries, vein and high flew shunts to perform a complete devascularization of the AVM.
Outcomes
Primary Outcome Measures
Occlusion of the feeding arteries and veins confirmation by imaging techniques
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
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
Detect prognostic factors that affect the outcomes: etiology
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: age
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: site and size
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: Primary arterial supply of the AVM, number of feeders
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.
Detect prognostic factors that affect the outcomes: clinical symptoms
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05341336
Brief Title
Outcome and Prognostic Factors of Surgical Management of Scalp AVMs.
Official Title
Outcome and Prognostic Factors of Surgical Management of Scalp Arteriovenous Malformations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirsoid Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical excision
Arm Type
Experimental
Arm Description
complete surgical excision of the scalp AVMs after identifying feeding arteries, vein and high flew shunts to perform a complete devascularization of the AVM.
Intervention Type
Procedure
Intervention Name(s)
total surgical excision
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occlusion of the feeding arteries and veins confirmation by imaging techniques
Description
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.
Time Frame
This will be monitored for a period of 6 months post-operative.
Title
Cosmetic outcome according to the modified Hollandar scale
Description
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.
Time Frame
This will be monitored for a period of 6 months post-operative.
Secondary Outcome Measure Information:
Title
Detect prognostic factors that affect the outcomes: etiology
Description
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.
Time Frame
This will be monitored for a period of 6 months post-operative.
Title
Detect prognostic factors that affect the outcomes: age
Description
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.
Time Frame
This will be monitored for a period of 6 months post-operative.
Title
Detect prognostic factors that affect the outcomes: site and size
Description
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.
Time Frame
This will be monitored for a period of 6 months post-operative.
Title
Detect prognostic factors that affect the outcomes: Primary arterial supply of the AVM, number of feeders
Description
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.
Time Frame
This will be monitored for a period of 6 months post-operative.
Title
Detect prognostic factors that affect the outcomes: clinical symptoms
Description
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.
Time Frame
This will be monitored for a period of 6 months post-operative.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdel-Basset Ali Mahmoud Khallaf, Prof
Phone
00201006071988
Email
khallaf@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Farrag Mohammad Farrag Saad, M.D.
Phone
01065652394
Email
Farragmohammad@aun.edu.eg
Facility Information:
Facility Name
Assiut University Hospitals
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdel-Basset Ali Mahmoud Khallaf, Prof
Phone
00201006071988
Email
khallaf@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Farrag Mohammad Farrag Saad, M.D
Phone
00201065652394
Email
Farragmohammad@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16598510
Citation
Gurkanlar D, Gonul M, Solmaz I, Gonul E. Cirsoid aneurysms of the scalp. Neurosurg Rev. 2006 Jul;29(3):208-12. doi: 10.1007/s10143-006-0023-y. Epub 2006 Apr 6.
Results Reference
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PubMed Identifier
8869152
Citation
Komiyama M, Nishikawa M, Kitano S, Sakamoto H, Imai K, Tsujiguchi K, Mizuno T. Non-traumatic arteriovenous fistulas of the scalp treated by a combination of embolization and surgical removal. Neurol Med Chir (Tokyo). 1996 Mar;36(3):162-5. doi: 10.2176/nmc.36.162.
Results Reference
background
PubMed Identifier
2366088
Citation
Heilman CB, Kwan ES, Klucznik RP, Cohen AR. Elimination of a cirsoid aneurysm of the scalp by direct percutaneous embolization with thrombogenic coils. Case report. J Neurosurg. 1990 Aug;73(2):296-300. doi: 10.3171/jns.1990.73.2.0296.
Results Reference
background
PubMed Identifier
30149169
Citation
Albuquerque Sousa LH, Maranha Gatto LA, Demartini Junior Z, Koppe GL. Scalp Cirsoid Aneurysm: An Updated Systematic Literature Review and an Illustrative Case Report. World Neurosurg. 2018 Nov;119:416-427. doi: 10.1016/j.wneu.2018.08.098. Epub 2018 Aug 24.
Results Reference
background
PubMed Identifier
31384940
Citation
Sofela A, Osunronbi T, Hettige S. Scalp Cirsoid Aneurysms: Case Illustration and Systematic Review of Literature. Neurosurgery. 2020 Feb 1;86(2):E98-E107. doi: 10.1093/neuros/nyz303. Erratum In: Neurosurgery. 2019 Dec 1;85(6):861.
Results Reference
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PubMed Identifier
33373833
Citation
Furtado SV, Srinivasa R, Vala K, Mohan D. Contemporary management of scalp cirsoid aneurysm: A dual-trained neurosurgeon's perspective. Clin Neurol Neurosurg. 2021 Feb;201:106437. doi: 10.1016/j.clineuro.2020.106437. Epub 2020 Dec 15.
Results Reference
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PubMed Identifier
17379525
Citation
Li F, Zhu S, Liu Y, Chen Y, Chi L, Chen G, Zhang J, Qu F. Traumatic arteriovenous fistula of the superficial temporal artery. J Clin Neurosci. 2007 Jun;14(6):595-600. doi: 10.1016/j.jocn.2006.04.011. Epub 2007 Mar 26.
Results Reference
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PubMed Identifier
22570590
Citation
Mohamed WN, Abdullah NN, Muda AS. Scalp arteriovenous malformation : a case report. Malays J Med Sci. 2008 Jul;15(3):55-7.
Results Reference
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PubMed Identifier
4682507
Citation
Khodadad G. Arteriovenous malformations of the scalp. Ann Surg. 1973 Jan;177(1):79-85. doi: 10.1097/00000658-197301000-00015. No abstract available.
Results Reference
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Outcome and Prognostic Factors of Surgical Management of Scalp AVMs.
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