| CTRI Number |
CTRI/2019/08/020605 [Registered on: 07/08/2019] Trial Registered Prospectively |
| Last Modified On: |
22/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomized controlled study comparing RFA of GSV and stripping in varicosity of GSV. |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED STUDY COMPARING RADIOFREQUENCY ABLATION AND STRIPPING OF GREAT SAPHENOUS VEIN IN THE MANAGEMENT OF VARICOSE VEINS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrita dua |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad medical college |
| Address |
Room no.309 LNRDH
Lok nayak hospital
New Delhi
DELHI
110002
India |
| Phone |
8058715690 |
| Fax |
|
| Email |
amritadua44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir jain |
| Designation |
Consultant general surgery |
| Affiliation |
Maulana azad medical college |
| Address |
BLT second floor
Lok nayak hospital
Mamc
New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
sudhirKumar11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir jain |
| Designation |
Consultant general surgery |
| Affiliation |
Maulana azad medical college |
| Address |
BLT second floor
Lok nayak hospital
Mamc
New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
sudhirKumar11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General surgery Maulana azad medical college . New Delhi |
|
|
Primary Sponsor
|
| Name |
General surgery department Maulana azad medical college |
| Address |
Lok nayak hospital
Bahadur Shah jafari marg
Delhi |
| Type of Sponsor |
Government 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 |
| Amrita dua |
maulana azad medical college |
Department of general surgery
Surgery ward 2A
New Delhi
DELHI |
8058715690
amritadua44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
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 |
Radiofrequency ablation of GSV |
GSV from 3-5 cm below SFJ upto knee is ablated with help of RFA probe. |
| Comparator Agent |
Stripping of GSV with flush ligation of SFJ. |
Stripping of GSV upto knee done along with SFJ ligation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Varicosity of great saphenous vein included under class IV,V,VI asper CEAP classification |
|
| ExclusionCriteria |
| Details |
Simultaneous involvement of SSV.
Deep vein thrombosis.
Bleeding diathesis.
Pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disappearance of visible varicosities after 3 months |
Disappearance of visible varicosities after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative analgesics requirement .
time to return to routine activity.
Numbness ,reduction or loss of any sensation.
reversal of skin changes.
healing of ulcers. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/08/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Varicose veins is very common disease globally. Standard technique used to deal with this is SFJ flush ligation and GSV stripping. Radiofrequency ablation is a new revolution in field of varicose vein treatment that is less invasive and effective in terms of cost and post op analgesia requirement and less invasive. This study aims at comparison of these two techniques in treatment of varicosity of GSV. |