Comparison of effectiveness, safety and results of short saphenous vein varicose veins with two methods of intravenous thermal ablation (EVTA) and foam sclerotherapy under ultrasound guidance
Design
A parallel-group, double-blind, randomized trial study on 40 patients
Excel software will be used for randomization
Settings and conduct
Patients with varicose veins in the path of the short saphenous vein referred to the Vascular Surgery Clinic of Shahada Tajrish Hospital were included in the study and after obtaining consent, they were randomly assigned to one of the two treatment groups. Patients in the operating room will not know the type of surgery.
Participants/Inclusion and exclusion criteria
Adults aged 18 years and older who have been diagnosed with short saphenous varices through clinical examination and Doppler ultrasound and experience associated symptoms are candidates for intravenous thermal treatments. are people who have already undergone treatments, people with significant co-morbidities that may complicate the treatment process, pregnant or lactating women, people with known allergies to the materials used in these procedures, people with active infections, patients with anatomical changes Significant will not be included in the study
Intervention groups
Endovenous Thermal Ablation Therapy
Main outcome variables
Persistence of reflux؛ Recurrence of reflux؛ Repetition of treatment؛ sural nerve injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170614034531N2
Registration date:2024-12-25, 1403/10/05
Registration timing:prospective
Last update:2024-12-25, 1403/10/05
Update count:0
Registration date
2024-12-25, 1403/10/05
Registrant information
Name
Niki Tadayon
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 1144
Email address
ntadayon@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2026-01-21, 1404/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of safety, efficacy and outcomes of EVTA and sono guided foam sclerotherapy for treating lesser saphenous vein varices.
Public title
Safety, efficacy of EVTA and sono guided foam sclerotherapy for treating lesser saphenous vein varices.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical and sonographic findings compatible with lesser saphenous varices
Exclusion criteria:
Prior surgery or intervention on varicose veins
History of deep vein thrombosis
Concurrent varicose veins in greater saphenous domain
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Single-digit random numbers were generated using Excel software. The order of these random numbers was considered as the number of people entering the study. If these generated numbers were between 1-4, the patient was assigned to the first group and between 5-9 to the second group. In the continuation of the work of each of the groups to which 20 patients were allocated, the generated numbers related to that group were removed from the random number generation chain.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants are not aware of the type of therapy
The physician who examines the patient after the operation and collects the data is also blind to the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
7th Floor, Bldg No.2 Shahid Beheshti University of Medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-08-08, 1403/05/18
Ethics committee reference number
IR.SBMU.LASER.REC.1402.018
Health conditions studied
1
Description of health condition studied
Varicose of the short saphenous vein
ICD-10 code
S85.4
ICD-10 code description
Injury of lesser saphenous vein at lower leg level
Primary outcomes
1
Description
Re-channeling
Timepoint
a week, 6 months, and a year later
Method of measurement
Sonography
2
Description
Persistence of reflux
Timepoint
a week, 6 months, and a year later
Method of measurement
sonography
3
Description
Recurrence of reflux
Timepoint
a week, 6 months, and a year later
Method of measurement
sonography
4
Description
Repeated treatment
Timepoint
a week, 6 months, and a year later
Method of measurement
sonography
5
Description
sural nerve injury
Timepoint
a week, 6 months, and a year later
Method of measurement
sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (laser): Intravenous laser ablation. Doppler ultrasound is performed on the patient while standing. Varicose veins, as well as the junction of the short saphenous vein with the pubic vein and the path of the short saphenous vein were marked on the skin with the help of Doppler ultrasound. The diameter of the short saphenous vein in the area behind the knee and 10 cm above the heel is measured and recorded by sonography. Then the patient lies down and using ultrasound, the location of the short saphenous vein in the ankle is identified. Using a micropuncture needle, a vascular sheet is placed inside the varicose vein. In relation to the cannulation site for the small saphenous vein, usually the most distal inferior segment is used, which is often in the middle of the cuff. Sometimes we will enter the short saphenous vein from a turbinate vein. The short saphenous vein is located in the vicinity of the sural nerve and is chosen to enter the short saphenous vein to reduce the possibility of injury to the median nerve of the leg. Then the laser probe is guided through the sheet into the varicose vein and goes to the saphenous popliteal area. In order to minimize the possibility of nerve damage from perivenous injection of tumescent solution (1000 ml saline 0.9%, 50 ml lidocaine 2%, 1 ml epinephrine 1:1000, 10 mEq NaHCO3) in the amount of at least 10 cc per Segman Darid is used. This solution is injected into the fascia of the short saphenous vein along the entire length of the vessel that is supposed to be destroyed under the ultrasound guide. This reduces the pain and bleeding, and by separating the varicose veins from the surrounding tissue, it reduces the possibility of thermal damage to the adjacent elements (skin and nerve). 1470 nm is released and destroys the vessel. At the end of the work, ultrasound is performed again in terms of DVT, and the patient is covered with a class 2 sock.
Category
Treatment - Surgery
2
Description
Intervention group (foam sclerotherapy): In the foam sclerotherapy group, a substance called sclerosant (1% tetradecyl sodium) is prepared in the form of foam using ambient air. Then a few scallops are placed from bottom to top in the path of the short funnel. In this method, the lowest place of cannulation is the ankle vein. While the saphenous pubic valve is kept closed by the ultrasound probe and the blood is drawn from the patient's leg by placing him in the Trendelenburg position, 2 cc of prepared foam is injected from the lower vein scope each time. . And it is removed from the upper scalp vein with a 10 cc syringe. A maximum of 10 cc of foam is injected in one session. At the end of the work, ultrasound is performed again in terms of DVT and class 2 socks are put on the patient
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Medical center
Full name of responsible person
Niki Tadayyon
Street address
Shohada Tajrish Hospital, Shahrdari st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
laser.cntr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shohada Tajrish Hospital, Shahrdari st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
laser.cntr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niki Tadayyon
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shohada Tajrish Hospital, Shahrdari st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
laser.cntr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niki Tadayyon
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shohada Tajrish Hospital, Shahrdari st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 912 947 1323
Email
laser.cntr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niki Tadayyon
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shohada Tajrish Hospital, Shahrdari st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD