Evaluation of addition of asymmetric compression dressing after thermal or chemical or surgical ablation of varicose veins to routine use of class II compression stockings (20mmHg pressure)
The aim of this study is to provide valuable insights into the effectiveness of asymmetrical dressing in addition to Class II compression stockings versus Class II stockings alone in reducing post-operative pain and enhancing recovery after varicose veins treatment.
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Patients with CEAP C2-C4 and significant reflux in GSV,AASV, PASV,SSV,who have visited the Vascular Surgery Clinic of the Shohada Tajrish hospital . 18-65 years old and no prior history of venous intervention on the affected limb. After EVTA, concomitant sclerotherapy and/or microphlebectomy. Participants in case group(asymmetrical dressing +Class 2 compression stocking) and control group Class 2 compression stocking .
The pain score is assessed using the visual analog scale (VAS) on Day 3 and day 10 following the procedure. Pain scores, return time to normal activities, and ecchymosis and thrombophlebitis are assessed. Patients are followed up in terms of relapse and satisfaction within 6 months of treatment .
Participants/Inclusion and exclusion criteria
Patients 18-65 years old with CEAP (C2-C4) varicose veins and significant reflux detected in duplex ultrasound in the GSV, AASV , PASV, or SSV after EVTA and concomitant sclerotherapy and/or micro phlebectomy are entered into this randomized controlled trial.
Intervention groups
At the end of the operation participants in the intervention group will receive asymmetrical compression dressing using vibrill or foam under class II compression stockings for 72 hours and in the control group class II compression stockings alone administered for 72 hours
Main outcome variables
Pain score; Return time to normal activities; Ecchymosis;Thrombophlebitis;Recurrence ; overall satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170614034531N1
Registration date:2023-09-24, 1402/07/02
Registration timing:registered_while_recruiting
Last update:2023-09-24, 1402/07/02
Update count:0
Registration date
2023-09-24, 1402/07/02
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
Recruitment complete
Funding source
Expected recruitment start date
2023-09-18, 1402/06/27
Expected recruitment end date
2023-11-18, 1402/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of addition of asymmetric compression dressing after thermal or chemical or surgical ablation of varicose veins to routine use of class II compression stockings (20mmHg pressure)
Public title
Evaluation of asymmetric compression dressing after thermal or chemical or surgical ablation of varicose veins.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with CEAP (C2-C4) varicose veins and significant reflux in duplex ultrasound in truncal veins (GSV, AASV,PASV, or SSV)
Exclusion criteria:
Any kind of previous treatment on the venous system of the affected limb.
Prior history of DVT in the affected limb
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation
Numbers 1- 80 are poured into the container, then 40 numbers are removed and registered without replacement, which will be the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is blind about the type of dressing under the compression stocking. (The foam additional compression is located under the well bonde and only the scrub nurse is aware of the dressing who does not play a role in the next stages of the study)
The clinical evaluator (assistant) visits the patient after the removal of the dressing so will be blinded about the kind of dressing. Data analyzers are also blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Laser Application Research Center in Medical Sciences, Shahid Beheshti
Street address
Shardari
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2023-09-13, 1402/06/22
Ethics committee reference number
IR.SBMU.LASER.REC.1402.022
Health conditions studied
1
Description of health condition studied
varicose vein
ICD-10 code
183.9
ICD-10 code description
Varicose veins of lower extremities without ulcer or inflammation
Primary outcomes
1
Description
Pain score with visual analogue scale (VAS)
Timepoint
3rd and 10th day post operative
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Recurrence
Timepoint
6 months post operative
Method of measurement
Duplex sonography
Intervention groups
1
Description
Intervention group:
Category
Treatment - Other
2
Description
Control group:
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish hospital
Full name of responsible person
Niki Tadayon
Street address
Shahrdari
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 1144
Fax
+98 21 2272 1144
Email
pr-shohada@sbmu.ac.ir
Web page address
https://shmc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Babak Javanmard
Street address
Shahrdari
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 1144
Fax
+98 21 2272 1144
Email
lasercentr@yahoo.com
Web page address
https://laser.sbmu.ac.ir/
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 Tadayon
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahrdari
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 1144
Fax
+98 21 2272 1144
Email
nntadayon@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niki Tadayon
Position
Assistant proffesor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahrdari
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 1144
Fax
+98 21 2272 1144
Email
nntadayon@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niki Tadayon
Position
Assistant Proffesor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shardari
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 1144
Fax
+98 21 2272 1144
Email
nntadayon@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
All data can be shared
When the data will become available and for how long
After publication
To whom data/document is available
Academic Investigators
Under which criteria data/document could be used
Analysis on data is approved
From where data/document is obtainable
E-Mail: ntadayonmd@gmail.com
What processes are involved for a request to access data/document