Outcome and Prognostic Factors of Surgical Management of Scalp AVMs.

NCT ID: NCT05341336

Last Updated: 2023-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Cirsoid Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

total surgical excision

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Antonios Bakheet Henis Soliman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Hospitals

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Abdel-Basset Ali Mahmoud Khallaf, Prof

Role: CONTACT

00201006071988

Farrag Mohammad Farrag Saad, M.D.

Role: CONTACT

01065652394

Facility Contacts

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Mohamed Abdel-Basset Ali Mahmoud Khallaf, Prof

Role: primary

00201006071988

Farrag Mohammad Farrag Saad, M.D

Role: backup

00201065652394

References

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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.

Reference Type BACKGROUND
PMID: 16598510 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8869152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2366088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30149169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31384940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33373833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17379525 (View on PubMed)

Mohamed WN, Abdullah NN, Muda AS. Scalp arteriovenous malformation : a case report. Malays J Med Sci. 2008 Jul;15(3):55-7.

Reference Type BACKGROUND
PMID: 22570590 (View on PubMed)

Khodadad G. Arteriovenous malformations of the scalp. Ann Surg. 1973 Jan;177(1):79-85. doi: 10.1097/00000658-197301000-00015. No abstract available.

Reference Type BACKGROUND
PMID: 4682507 (View on PubMed)

Other Identifiers

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OPFSMSAM

Identifier Type: -

Identifier Source: org_study_id

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