| CTRI Number |
CTRI/2019/04/018703 [Registered on: 24/04/2019] Trial Registered Prospectively |
| Last Modified On: |
17/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [LASER TREATMENT AND SCLEROSANT INJECTION IN VARICOSITIES] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison Of The Outcomes Of Simultaneous Laser Treatment And Injection Sclerotherapy Versus Laser Treatment Alone In Patients With Varicose Veins of Legs |
|
Scientific Title of Study
|
Comparison Of The Outcomes Of Concomitant Truncal Laser Ablation And Tributary Foam Sclerotherapy Versus Truncal Laser Ablation Alone In Patients With Lower Extremity Venous Reflux - A Single Centre Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vineeta Ojha |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room No 10A, Department Of Cardiovascular Radiology and Endovascular Interventions, Ground Floor, Cardiothoracic Centre, Aiims, New Delhi-110049
South West
DELHI
110049
India |
| Phone |
9051721696 |
| Fax |
|
| Email |
vineetao17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeev Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room No 10A, Department Of Cardiovascular Radiology and Endovascular Interventions, Ground Floor, Cardiothoracic Centre, Aiims, New Delhi-110049
South West
DELHI
110049
India |
| Phone |
|
| Fax |
|
| Email |
sanjeevradio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vineeta Ojha |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room No 10A, Department Of Cardiovascular Radiology and Endovascular Interventions, Ground Floor, Cardiothoracic Centre, Aiims, New Delhi-110049
South West
DELHI
110049
India |
| Phone |
9051721696 |
| Fax |
|
| Email |
vineetao17@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
AIIMS |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vineeta Ojha |
AIIMS, New Delhi |
Cathlab-5, Department of Cardiovascular Radiology and Endovascular Interventions, Cardiothoracic Centre
South West
DELHI |
9051721696
vineetao17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Concomitant EVLA and Foam Sclerotherapy |
Both EVLA and foam sclerotherapy will be done simultaneously in same sitting in one group. |
| Comparator Agent |
EVLA alone |
One group will receive only EVLA in the primary sitting |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a. Age 18-75years, informed consent
b. C2-6, Epr, A s, according to the CEAP classification (clinical, etiologic, anatomical, and pathophysiological (CEAP) )
c. Primary signs and symptoms of truncal(saphenous, accessory, non saphenous) vein incompetence/relux with reflux time of 1 sec or more on Doppler, and diameter of varicose veins more than 3mm and less than 15mm, diameter of perforator >3mm.
c. an accessible vein.
|
|
| ExclusionCriteria |
| Details |
1. Any patient who doesn’t give consent for being included in the study.
2. Evidence of peripheral arterial disease
3. any previous treatment, such as surgery, EVLA, radiofrequency ablation, or FS, for ipsilateral varicosity.
4. lower limb varicosity caused by deep venous thrombosis.
5. coagulation disorder, pregnancy, lactation, current thrombosis, systemic disease, poor general health, or allergy to sodium tetradecyl sulfate (STS)
6. Contraindication to iodinated contrast media
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Aberdeen Varicose Vein Questionnaire (AVVQ) |
24 hours, 1 week, 4 weeks, 3months and 6months after procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D), numerical rating scale (NRS) scores, CEAP score |
24 hours, 1 week, 4 weeks, 3months and 6months after procedure |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/05/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Varicose veins are extremely common worldwide . Currently, endovenous thermal ablations and foam sclerotherapy are the standard of care for chronic venous reflux disease. Residual varicose veins-associated symptoms and cosmetic issues are becoming a matter of clinical controversy. Usually, endovenous laser ablation is done alone followed by a staged sclerotherapy if required at 6-8weeks. In recently published randomized controlled trials (RCTs), concomitant phlebectomy with truncal treatment reduced the need for staged procedures and improved quality of life (QoL). Simultaneous treatment of varicose veins may increase operative time and outpatient discomfort. However, this combination procedure significantly reduces the number of patients who need a staged treatment of residual varicose veins for cosmetic and symptomatic reasons. Clinical safety, feasibility, and effectiveness of simultaneous EVLA and FS have not yet been fully confirmed in a randomized study till date. The aim of this study was to compare the outcomes of patients who received simultaneous EVLA and FS with those receiving truncal lasering alone in single sitting. |