跳至主要内容
临床试验/CTRI/2023/07/055815
CTRI/2023/07/055815尚未招募不适用

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

CDSIMER1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年7月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
components of rVCSS :Pain, Varicose veins, Venous edema, skin pigmentation, Inflammation, induration, active ulcer number, duration & size, use of compressive therapy.

研究概览

简要总结

Varicose veinsare 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 theother ethnic groups.

Varicose veinsare superficial, dilated, tortuous and enlarged veins, generally larger than3mm in  diameter,  occuringdue to loss of valvular efficiency which is a product of the resultant venoushypertension in standing position

Various Venous outcomes assessment toolshave been used to evaluate the severity of venous disease and providestandardized evaluation of treatment effectiveness.

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

 Venous valvular incompetence/reflux assessedby venous doppler study using the Valsalva test and calf compression (manual orwith a pneumatic cuff) is the most frequently used ultrasound criterion forsignificant 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 refluxshown by reversed flow during decompression.

They have been used asindependent determinants of venous disease severity, but correlationbetween these tools has not been tested.

Thisstudy is undertaken to correlate VCSS (venous clinical severity score) withgrading of VRS (venous reflux score) by using the standard colour Doppler inlower limb varicose veins

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients who come to surgical OPD with primary varicose veins diagnosed by history, clinical examination and imaging techniques.

排除标准

  • 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).

结局指标

主要结局

components of rVCSS :Pain, Varicose veins, Venous edema, skin pigmentation, Inflammation, induration, active ulcer number, duration & size, use of compressive therapy.

时间窗: baseline

VRS duration in seconds

时间窗: baseline

次要结局

  • no other outcomes studied(not applicable)

研究者

发起方
CDSIMER
申办方类型
Private medical college

研究点 (1)

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