To assess the effect of surgery versus radiofrequency ablation method on treatment varicose veins
Design
This is a Phase III randomized clinical trial with a control group, in which eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct
This study will be conducted at the Besat Hospital in Hamadan city, involving 50 eligible patients with varicose veins of the lower limbs. The patients will be randomly assigned to the intervention groups through the drawing of lots. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 80 years
Varicose veins of the lower limbs
Saphenofemoral insufficiency
Exclusion criteria:
Insufficiency in the deep venous system
Intervention groups
Intervention group:
The radiofrequency ablation catheter is pushed into the vein lumen and the entire length of the great saphenous vein is blocked with a temperature of 120 degrees Celsius for 20 seconds from the saphenofemoral junction to the catheter entry point.
Intervention group 2:
Removal of varicose veins of the great saphenous vein surgically under general anesthesia
Main outcome variables
Primary outcome:
Saphenous vein recanalization rate; recurrence of saphenous femoral reflux
Secondary outcome:
Deep vein thrombosis; saphenous nerve damage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N487
Registration date:2023-10-29, 1402/08/07
Registration timing:prospective
Last update:2023-10-29, 1402/08/07
Update count:0
Registration date
2023-10-29, 1402/08/07
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of surgery versus radiofrequency ablation method on treatment varicose veins: a randomized clinical trial
Public title
Effect of surgery versus radiofrequency ablation method on treatment varicose veins
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 80 years
Varicose veins of the lower limbs
Saphenofemoral insufficiency
Exclusion criteria:
Insufficiency in the deep venous system
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.UMSHA.REC.1402.289
Health conditions studied
1
Description of health condition studied
Varicose veins of the lower limbs
ICD-10 code
I83
ICD-10 code description
Varicose veins of lower extremities
Primary outcomes
1
Description
Saphenous vein recanalization rate
Timepoint
One week, 3 months and 6 months after the intervention
Method of measurement
Using Doppler ultrasound
2
Description
Recurrence of saphenous femoral reflux
Timepoint
One week, 3 months and 6 months after the intervention
Method of measurement
Using Doppler ultrasound
Secondary outcomes
1
Description
Deep vein thrombosis
Timepoint
One week, 3 months and 6 months after intervention
Method of measurement
By clinical examination
2
Description
Saphenous nerve damage
Timepoint
One week, 3 months and 6 months after intervention
Method of measurement
By clinical examination
Intervention groups
1
Description
Intervention group 1: The radiofrequency ablation catheter is pushed into the vein lumen and the entire length of the great saphenous vein is blocked with a temperature of 120 degrees Celsius for 20 seconds from the saphenofemoral junction to the catheter entry point.
Category
Treatment - Devices
2
Description
Intervention group 2:Removal of varicose veins of the great saphenous vein surgically under general anesthesia
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Fatemeh Kazemi Afshar
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
abbasumsha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Kazemi Afshar
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
abbasumsha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Amir Derakhshanfar
Position
Vascular Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dramirderakhshanfar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available