The measurement of the rate of recurrence, the period of return to daily activities, the rate of pain relief, the cost of spent , and the quality of life improvement in the two groups under treatment by foam sclerotherapy and radiofrequency ablation.
Design
The study is a clinical trial with parallel groups.The patients are selected from those with varicosis secondary to primary insufficiency of great saphenous vein. 60 patients with inclusion criteria are selected through available sampling method then they are divided in one of two groups foam sclerotheraphy and radiofrequency ablation randomly by using 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 Kermanshah City. 60 patients in two groups are treated with radiofrequency ablation and foam sclerotherapy. In group 1 radiofrequency ablation is performed by thermal ablation of the great saphenous vein . In group 2 the foam sclerotherapy is performed by chemical ablation of the great saphenous vein. At the end, these two groups are compared based on results of the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent of patient
patients with primary varicosis following insufficiency of great saphenous vein
Exclusion criteria: failure to collaboration for follow up
Intervention groups
In this study ,the patients are divided into two groups:
Group 1: treated with foam sclerotherapy that is chemical ablation of endothelium
Group 2: treated with radiofrequency ablation that is thermal ablation of endothelium
Main outcome variables
The rate of disease recurrence
The recovery time
The cost of spent
The quality of life
The compression of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180223038837N1
Registration date:2018-12-08, 1397/09/17
Registration timing:registered_while_recruiting
Last update:2018-12-08, 1397/09/17
Update count:0
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
Mohammad Reza Sobhiyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6333
Email address
mohammadreza.sobhieh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of radiofrequency ablation & foam sclerothrapy for treatment patients suffering from great saphenous varicose 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
The patient suffers from great saphenous varicose vein
No history of varicose vein
The diameter of the great saphenous vein at 3 cm below the saphenophemoral junction in Doppler sonography is between 10 to 20 mm.
No duplication of varicose vein
Non-use of anti-coagulans and antiplatelet drugs
No history of vascular insufficiency
Exclusion criteria:
Failure to collaborate for follow-up
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 60 patients with entering criteria were selected by available sampling. Then, randomly using a random number table, they are placed in one of two groups of foam sclerotherapy and RFA
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 Kermanshah University of Medical Sciences
Street address
Imam Reza Hospital, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.KUMS.REC.1397.493
Health conditions studied
1
Description of health condition studied
Varicose veins of lower extremities
ICD-10 code
I83
ICD-10 code description
Varicose veins of lower extremities
Primary outcomes
1
Description
Recurrence of Varicose Veins
Timepoint
One week, one month, three months, six months and 12 months 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-36 questionnaire
2
Description
Intensity of pain
Timepoint
Before and a week after treatment
Method of measurement
Visual Analoge Scale
3
Description
Condition of Varicose veins
Timepoint
Before and a week after treatment
Method of measurement
Aberdeen Varicose Veins Questionnaire
4
Description
The interval between the treatment process and the return to usual life
Timepoint
after treatment
Method of measurement
The patient is asked
5
Description
The cost of treatment
Timepoint
After treatment
Method of measurement
Documentation file
Intervention groups
1
Description
Interventional Group 1: This group treated with radiofrequency ablation .Treatment includes segmental thermal ablation of great saphenous vein through a catheter by seven-centimeters element . thermal ablation started two centemeters of below the saphenofemoral junction. In each segment, temperature remains at about 120 degree centegrades for 20 seconds. In this project used radiofrequency catheter for Covidian brand, made in Costa Rica, to do ablation.
Category
Treatment - Devices
2
Description
Intervention group 2(Foam sclerotherapy): This group will be treated with Foam sclerotherapy . Foam includes fibrovein with air with a ratio of one- fifth (with Tesari Method) is mixed and injected into the vein Under ultrasound guidance. It continues as long as the foam reaches of two centimeter of saphenofemoral junction and causes ablation in the vein Endothelium by chemical inflammation. In this project, Sclerosing substance of fibrovein brand, made in England , is used for foam sclerotherapy.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohammadreza Sobhieh
Street address
Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6301
Email
admin@irhk.ir
Web page address
http://www.irhk.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Administrative building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah City, Iran
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3837 0541
Email
Farid_n32@yahoo.com
Web page address
http://vc-research.kums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Sobhiyeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital., Parastar Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6333
Fax
Email
mreza.sobhiyeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Sobhiyeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam reza hospital-parastar Ave-kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6333
Fax
Email
mreza.sobhiyeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Sobhiyeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam reza hospital-parastar Ave-kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6333
Fax
Email
mreza.sobhiyeh@yahoo.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 unidentification 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 Mohammadreza Sobhiyeh.
Email: mreza.sobhiyeh@yahoo.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.