Treatment of Venous Malformation

Not Applicable

Completed

• Conditions: Venous Malformation
• Interventions: Procedure: Direct Puncture Repair / Ethanol; Procedure: Direct Puncture Repair / Polidocanol

• Registration Number: NCT05586919
• Lead Sponsor: Al-Azhar University

Brief Summary

Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-03-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-01
• Study First Submitted QC: 2022-10-16
• Last Update Submitted: 2022-10-16
• Study First Posted: 2022-10-19
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients diagnosed with venous malformation of both genders and age above one year.

Exclusion Criteria

• Age below one year.
• Patients had any other vascular malformations.
• Indication for contrast material or Alcohol and polidocanol injection.
• Unfit for general anesthesia. 5) Pregnancy. 6) Skin infection, inflammation, and ulcers.
• Pulmonary embolism.
• Acute Ischemia, and acute DVT.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Puncture Repair / Ethanol	Direct Puncture Repair / Ethanol	-
Direct Puncture Repair / Polidocanol	Direct Puncture Repair / Polidocanol	-

Primary Outcome Measures

Name	Time	Method
Disfigurement questionnaire	6 months post operative	Disfigurementof the affected part may be unchanged, or decreased or disppeared, or relapsed
Heaviness questionnaire	6 months post operative	Heaviness of the affected part may be unchanged, or decreased or disppeared, or relapsed
size of venous malformation	6 months post operative	it assess the size of malformations after injection; which may be unchanged, or decreased or disppeared, or relapsed
Degree of satisfaction	6 months post operative	It may be; Very satisfied, or satisfied, or not satisfied, or Dissatisfied.

Trial Locations

Locations (1)

Walied Khereba; 🇪🇬 Zagazig, Egypt