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CTRI Number  CTRI/2023/07/055815 [Registered on: 28/07/2023] Trial Registered Prospectively
Last Modified On: 27/07/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Correlation between clinical and radiological findings in varicose veins 
Scientific Title of Study   A Correlative Study of revised Venous clinical severity score [rVCSS] and Venous reflux doppler grading [VRS] in primary lower limb Varicose veins at a tertiary care  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varsha R K 
Designation  Assistant Professor 
Affiliation  Chandramma Dayanand Sagar Institute of Medical Educaton and Research 
Address  Department of General Surgery, Chandramma Dayanand Sagar Institute of Medical Educaton and Research, Devarakaggalahalli, Harohalli, Kanakapura Road,Karnataka

Bangalore Rural
KARNATAKA
562112
India 
Phone  9632378756  
Fax    
Email  varshark07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Varsha R K 
Designation  Assistant Professor 
Affiliation  Chandramma Dayanand Sagar Institute of Medical Educaton and Research 
Address  Department of General Surgery, Chandramma Dayanand Sagar Institute of Medical Educaton and Research, Devarakaggalahalli, Harohalli, Kanakapura Road,Karnataka

Bangalore Rural
KARNATAKA
562112
India 
Phone  9632378756  
Fax    
Email  varshark07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Varsha R K 
Designation  Assistant Professor 
Affiliation  Chandramma Dayanand Sagar Institute of Medical Educaton and Research 
Address  Department of General Surgery, Chandramma Dayanand Sagar Institute of Medical Educaton and Research, Devarakaggalahalli, Harohalli, Kanakapura Road,Karnataka

Bangalore Rural
KARNATAKA
562112
India 
Phone  9632378756  
Fax    
Email  varshark07@gmail.com  
 
Source of Monetary or Material Support  
CDSIMER DEVARAKAGGALAHALLI, HAROHALLI, Kanakapura Rd, Kanakapura, Karnataka 562112 
 
Primary Sponsor  
Name  CDSIMER 
Address  DEVARAKAGGALAHALLI, HAROHALLI, Kanakapura Rd, Kanakapura, Karnataka 562112 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Varsha R K  CDSIMER  Room no 4, Department of General Surgery, CDSIMER, Devarakgalahalli, Harohalli, Kanakapura Rd, Kanakapura, Karnataka 562112
Bangalore Rural
KARNATAKA 
9632378756

varshark07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CDSIMER IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I839||Asymptomatic varicose veins of lower extremities, (2) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation, (3) ICD-10 Condition: I831||Varicose veins of lower extremities with inflammation, (4) ICD-10 Condition: I838||Varicose veins of lower extremities with other complications, (5) ICD-10 Condition: I830||Varicose veins of lower extremities with ulcer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients who come to surgical OPD with primary varicose veins diagnosed by history, clinical examination and imaging techniques. 
 
ExclusionCriteria 
Details  1.secondary varicose veins
2.Varicose vein with Peripheral arterial disease
of lower limbs
3.Isolated perforator incompetence and SPJ
incompetence
4.Recurrent varicose veins after previous
surgery(REVAS)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
components of rVCSS :Pain, Varicose veins, Venous edema, skin pigmentation, Inflammation, induration, active ulcer number, duration & size, use of compressive therapy.
VRS duration in seconds  
baseline 
 
Secondary Outcome  
Outcome  TimePoints 
no other outcomes studied  not applicable 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Varicose veins are a common chronic venous disorder affecting 20 to 60% of adults worldwide. However, the disease occurrence varies significantly by geographical region; with comparatively lowered incidence of 19% in Asian ethnic group than the other ethnic groups.

Varicose veins are superficial, dilated, tortuous and enlarged veins, generally larger than 3mm in  diameter,  occuring due to loss of valvular efficiency which is a product of the resultant venous hypertension in standing position

Various Venous outcomes assessment tools have been used to evaluate the severity of venous disease and provide standardized evaluation of treatment effectiveness.

To standardize the diverse clinical manifestations of CVI, clinical, etiological, anatomical, and pathological (CEAP) classification was developed by American Venous Forum at the sixth annual meeting in 1994.[4] It lacks the ability to assess disease severity. An Ad hoc Committee of the American Venous Forum on Venous Outcome Assessment proposed venous clinical severity score (VCSS) on March 2000.

 

Venous valvular incompetence/reflux assessed by venous doppler study using the Valsalva test and calf compression (manual or with a pneumatic cuff) is the most frequently used ultrasound criterion for significant reflux in many studies. It is a semi-quantitative grading (1=mild, 2=moderate and 3=severe) based on blood flow velocity and duration of reflux shown by reversed flow during decompression.

They have been used as independent determinants of venous disease severity, but correlation between these tools has not been tested.

This study is undertaken to correlate VCSS (venous clinical severity score) with grading of VRS (venous reflux score) by using the standard colour Doppler in lower limb varicose veins

 
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