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CTRI Number  CTRI/2025/02/080314 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   longitudinal 
Study Design  Other 
Public Title of Study   This study aims to observe and compare how two different treatments for varicose veins that is ,radiofrequency ablation and Trendelenburg surgery affect the quality of life of patients using, questionnaire called VEINES QOL/SYM. 
Scientific Title of Study   Prospective observational and comparative study utilizing VEINES QOL/SYM questionnaire to assess health related quality of life following patient undergoing radio frequency ablation and Trendelenburg surgery for varicose veins 
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 M Sai Rohith 
Designation  Post graduate 
Affiliation  Kasturba medical college  
Address  Kasturba medical college Department of General surgery Manipal

Nellore
ANDHRA PRADESH
524001
India 
Phone  7530057052  
Fax    
Email  rohithmunamala@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharath SV 
Designation  Associate professor 
Affiliation  Kasturba medical college 
Address  Department of general surgery KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  9148586336  
Fax    
Email  bharath.sv@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Pavan bhat 
Designation  Assistant professor 
Affiliation  Kasturba medical college 
Address  Department of general surgery KMC manipal


KARNATAKA
576104
India 
Phone  9731243720  
Fax    
Email  pavan.madhukar1@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba medical college Department of general surgery Madhav Nagar Manipal 576104 Karnataka India 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Rohith Reddy  kasturba medical college  Department of general surgery KMC Manipal
Udupi
KARNATAKA 		 7530057052

rohithmunamala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and Kasturba hospital Institutional Ethics Committee-2(Student research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I838||Varicose veins of lower extremities with other complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients undergoing surgical procedure for varicose veins at Kasturba Hospital,
Manipal
Patient willing and able to provide Written informed consent.
Patients more than 18 years of age  
 
ExclusionCriteria 
Details  pregnant females
Patients below 18 years
Secondary and Recurrent varicose veins 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study helps in better understanding of the effect of the individual
procedures on the health related quality of life in the individual undergoing RFA and
Trendelenburg on health related quality of life in an individual with varicose veins 		 1month , 3months and 6months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="103"
Sample Size from India="103" 
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)   08/01/2026 
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="3"
Days="10" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rohithmunamala@gmail.com].

  6. For how long will this data be available start date provided 27-09-2026 and end date provided 27-09-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
It is a prospective observational study which will
be conducted at Kasturba Medical College Manipal Academy of Higher Education, Manipal.
After attaining clearance from the Institutional Ethics Committee and informed consent from
patient, patients who are clinical and radiologically diagnosed with varicose veins and
admitted in the Dept of General Surgery, KMC Manipal, for the varicose veins surgery
Trendelenburg surgery or RFA during the time period of March 2024 to September 2025. The
type of surgery that the patient undergoes will be determined by the operating surgeon and
the relevant team. This research project will have no bearing over the choice of surgery that
the patient undergoes. Patients that consent to participating in the study and meet the
inclusion criteria will be divided into groups based on the type of procedure RFA or
trendelenburg that they are planned to undergo will be approached prior to the surgery and
patient will be explained about the study and about the VEINES QOL/SYM questionnaire. The
recruited subject will be given half an hour to complete the questionnaire.The VEINES
QOL/SYM questionnaire will be administered to recruited patients preoperatively.All recruited
patients will be asked to repeat the same questionnaire postoperatively at 1 month, 3 months
and 6 months (follow-up in OPD as per routine standard of care, or telephonically or via email
if the patient does not visit the OPD for follow-up). Data collected will be analyzed to assess
the change in quality of life and symptom severity as reported by the patients in the VEINES
QOL/SYM questionnaire recorded preoperatively, and at 1 month, 3 months and 6 months
post-operatively, and this will be compared between the two groups RFA and Trendelenburg procedure
 
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