Our aim in this study is to investigate and compare the success rate in the closure of the small saphenous vein reflux in these two methods and also to investigate the complications (such as infection, thrombophlebitis, deep vein thrombosis, pulmonary embolism, bleeding, hyperpigmentation, improving the quality of life).
Design
The study is a clinical trial with parallel groups. The patients are selected from those with varicosis insufficiency of small saphenous veins. 50 patients with inclusion criteria are selected through the available sampling method then they are divided into one of two groups foam sclerotherapy and radiofrequency ablation randomly by using a random number table. The trial phase is not applied in this study. The intervention groups are parallel and there is no possibility of blinding.
Settings and conduct
The goal of this study is the comparison of two type modality in varicose vein treatment in Tehran City. 50 patients in two groups are treated with radiofrequency ablation and foam sclerotherapy. In group 1 radiofrequency ablation is performed by thermal ablation of the small saphenous vein. In group 2 the foam sclerotherapy is performed by chemical ablation of the small saphenous vein. In the end, these two groups are compared based on the results of the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent of patient patients with primary varicosis following insufficiency of small saphenous vein Exclusion criteria: failure to collaborate for follow up
Intervention groups
In this study, the patients are divided into two groups: Group 1: treated with foam sclerotherapy which is chemical ablation of endothelium Group 2: treated with radiofrequency ablation which is thermal ablation of the endothelium.
Main outcome variables
The rate of disease recurrence, The quality of life, deep vein thrombosis, infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230721058865N1
Registration date:2023-08-05, 1402/05/14
Registration timing:prospective
Last update:2023-08-05, 1402/05/14
Update count:0
Registration date
2023-08-05, 1402/05/14
Registrant information
Name
Razieh Niazkeykha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9256
Email address
niazkeykha.r@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Thermal ablation versus foam sclerotherapy for treatment of small saphenous vein
Public title
Comparative study of radiofrequency ablation & foam sclerotherapy for treatment patients suffering from varicose veins
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious patient consent to enter the study; patients who have 18 years old and suffering from lesser saphenous varicose veins.
Exclusion criteria:
Failure to collaborate for follow-up
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method is used, in which the randomization unit is individual, and random sequence generation software (Random Number Generator software) is used. For concealment, non-transparent sealed envelopes with a random sequence are used. In this method, each random number created is recorded on a card and the cards are placed inside the envelopes in order. To maintain the random sequence of the envelopes on the outer surface, the numbering is done in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
North Kargar, Amirabad, Tehran heart center, The rate of disease recurrence, The quality of life, deep vein thrombosis, infection
City
Tehran
Province
Tehran
Postal code
13138-14117
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.TUMS.THC.REC.1402.041
Health conditions studied
1
Description of health condition studied
Small saphenous vein reflux
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Recurrence of Varicose Veins
Timepoint
six weeks after treatment
Method of measurement
Color Doppler Ultrasonography
Secondary outcomes
1
Description
Quality of life
Timepoint
Before and a week after treatment
Method of measurement
SF-12 questionnaire
Intervention groups
1
Description
Intervention group: Interventional Group 1: This group was treated with radiofrequency ablation. Treatment includes segmental thermal ablation of a small saphenous vein through a catheter by a seven-centimeters element. In each segment, the temperature remains at about 120 degrees centigrade for 20 seconds.
Category
Treatment - Devices
2
Description
Intervention group: Intervention group 2 (Foam sclerotherapy): This group will be treated with Foam sclerotherapy. The foam was injected into the vein Under ultrasound guidance. It causes ablation in the vein Endothelium by chemical inflammation.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Raziyeh Niazkeykha
Street address
North kargar, Amirabad
City
Tehran
Province
Tehran
Postal code
1313814117
Phone
+98 21 8802 9600
Fax
Email
thc@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Haleh Ashraf
Street address
North kargar, Amirabad
City
Tehran
Province
Tehran
Postal code
1313814117
Phone
+98 21 8802 9600
Email
thc@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Niazkeykha
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Northkargar, Amirabad, Tehran heart center
City
Tehran
Province
Tehran
Postal code
1313814128
Phone
+98 21 8002 9600
Email
niazkeykha.r@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Yaser Jenab
Position
Associate profesor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
North kargar, Amirabad, Tehran heart center
City
Tehran
Province
Tehran
Postal code
1313814117
Phone
+98 21 8002 9600
Email
yasjenab@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh niazkeykha
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
North kargar, Amirabad
City
Tehran
Province
Tehran
Postal code
131314117
Phone
+98 21 8002 9600
Email
niazkeykha.r@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In the case of the participant's data file, three months after the publication of the article and after the un-identification of the persons, the request can be sent by email.
When the data will become available and for how long
Three months after the publication of the article, upon request, by email, there is a possibility to post.
To whom data/document is available
Only scholars working in academic and scientific institutions
Under which criteria data/document could be used
The name of the first author of the study is required in an extracted article from the study data. In this case, it is possible to perform any statistical analysis.
From where data/document is obtainable
Correspondence by e-mail with the Doctor Yaser Jenab yasjenab@gmail.com
What processes are involved for a request to access data/document
Up to one week after receipt of the email, the requested documentation is sent.