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Clinical Trials/NCT05586919
NCT05586919
Completed
Not Applicable

Treatment of Venous Malformation by Direct Puncture Repair: Ethanol Versus Polidocanol

Al-Azhar University1 site in 1 country20 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous Malformation
Sponsor
Al-Azhar University
Enrollment
20
Locations
1
Primary Endpoint
Disfigurement questionnaire
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
March 1, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Walied Khereba

Principal Investigator

Al-Azhar University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Disfigurement questionnaire

Time Frame: 6 months post operative

Disfigurementof the affected part may be unchanged, or decreased or disppeared, or relapsed

Heaviness questionnaire

Time Frame: 6 months post operative

Heaviness of the affected part may be unchanged, or decreased or disppeared, or relapsed

size of venous malformation

Time Frame: 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

Time Frame: 6 months post operative

It may be; Very satisfied, or satisfied, or not satisfied, or Dissatisfied.

Study Sites (1)

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