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
|
|
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
|
|
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 |