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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06437561
Other study ID # 114099
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 13, 2024
Est. completion date March 15, 2024

Study information

Verified date May 2024
Source Golestan University of Medical sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Venous aneurysms are not common in general, but because of the inherent risk of thrombosis in aneurysms, their timely diagnosis and treatment are recommended in most of the current sources. Ten cases of venous aneurysms were diagnosed and managed in our vascular surgery department from October 2018 to January 2024. Patient information was extracted from their files retrospectively.


Description:

A vascular aneurysm is defined as the focal dilatation of a vessel. Aneurysm is classically used for arterial dilatations, although dilatations can occur in any part of the vascular system including veins. Venous aneurysms are not common in general, but with the increase in the use of duplex ultrasound, the number of cases diagnosed with venous aneurysms has recently increased. Venous aneurysms are more common in the lower limbs, and in the lower limbs, the involvement of the deep venous system is much more than the superficial venous system. According to reports, 77% of venous aneurysms are present in the lower limbs, of which 57% are in the deep venous system and 1.5% in the superficial venous system. Considering their rarity, venous aneurysms may cause diagnostic challenges in some cases. The importance of these aneurysms, especially in the lower limbs, which inherently have relative stasis due to the opposite flow direction of gravity, is that by creating venous stasis and whirlwind blood flow inside the aneurysm, they increase the susceptibility to clotting. Also, due to dysfunction of the pigeon nest valves, they cause chronic venous insufficiency. Although clot formation and subsequent pulmonary embolism are more common in deep venous aneurysms, cases of pulmonary embolism secondary to superficial venous aneurysms of the lower limbs have also been reported. Complications caused by chronic venous insufficiency are more common in aneurysms that occur at the main junctions of superficial and deep veins, including saphenous femoral and saphenous popliteal junctions. Considering the possible complications mentioned about venous aneurysms, these aneurysms need treatment, regardless of their location, and although in the superficial system, surgical resection is the most commonly recommended method, other surgical methods such as aneurysmectomy and primary repair, resection, and graft interposition, and also endovascular methods have been used. Of course, in case of insufficiency in the venous system, specific treatment of the cause of insufficiency (such as stripping of the large saphenous vein) is necessary in addition to the treatment of the aneurysm. Regarding the follow-up after the treatment of aneurysms of the superficial system, most articles have recommended short-term treatment with anticoagulants and control of the superficial and deep systems through color doppler. In this case series, we present 10 cases of venous aneurysms and discuss their presentation, diagnosis, and management.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 15, 2024
Est. primary completion date March 11, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: • Clinical diagnosis of venous aneurysm Exclusion Criteria: • Patient's non-consent

Study Design


Locations

Country Name City State
Iran, Islamic Republic of Pezhman Kharazm, MD Gorgan Golestan

Sponsors (1)

Lead Sponsor Collaborator
Golestan University of Medical sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinical presentation of extremity venous aneurysms different clinical presentations of extremity venous aneurysms and their prevalence 6 years
Primary age distribution of extremity venous aneurysms prevalence of extremity venous aneurysms in different ages 6 years
Primary location distribution of extremity venous aneurysms prevalence of extremity venous aneurysms in upper vs. lower limbs as well as left side vs. right side 6 years
Primary sex distribution of extremity venous aneurysms prevalence of extremity venous aneurysms in both sexes 6 years
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