| CTRI Number |
CTRI/2025/08/092748 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of post operative outcomes after different surgeries (RFA and EVLA) in varicose veins patients. |
|
Scientific Title of Study
|
Comparison between early post operative outcomes after RFA and EVLA surgeries in varicose veins patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Carol Mary Shaju |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, Third Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
07506020998 |
| Fax |
|
| Email |
carol.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Badareesh L |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, Third Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09844774035 |
| Fax |
|
| Email |
badareesh.l@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshen M Samuel |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, Third Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08123306328 |
| Fax |
|
| Email |
roshen.samuel@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Madhav Nagar, Manipal, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
3rd floor, Department of General Surgery, Smt. Sharada Pai OPD Block, Kasturba Hospital, Manipal 576104 |
| 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 Carol Mary Shaju |
Kasturba Hospital, Manipal |
Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
7506020998
carol.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethucs Committee -2 |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Varicose Veins patients |
|
| ExclusionCriteria |
| Details |
Pregnant or breastfeeding women
Patients with active deep vein thrombosis (DVT).
Comorbidities such as coagulopathies.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of early post operative complications in patients undergoing Radiofrequency ablation and Endovenous laser ablation. |
Data will be collected at baseline (pre-operatively), immediate post-operatively and 4 weeks after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
21/08/2025 |
| 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="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 and often debilitating condition that affects a significant proportion of the population, leading to symptoms such as leg pain, swelling, and aesthetic concerns. Several treatment options exist to manage varicose veins, with Radiofrequency Ablation (RFA) and Endovenous Laser Ablation (EVLA) being two of the most widely used and minimally invasive techniques for addressing the condition. Although RFA and EVLA are commonly used to treat varicose veins, there is no clear consensus in the literature about which treatment method offers better clinical outcomes. There are variations in success rates, complication profiles and patient satisfaction between the two procedures. A well-structured study is needed to provide robust, comparative evidence to guide clinical decision-making. |