Treatment of Venous Malformation by Direct Puncture Repair: Ethanol Versus Polidocanol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Disfigurement questionnaire
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Months to 36 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Walied Khereba
Principal Investigator
Al-Azhar University