| CTRI Number |
CTRI/2025/02/080433 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Varicose vein( Dilated veins) by laparoscopic Surgery |
|
Scientific Title of Study
|
Subcutaneous Endoscopic Varicose Vein Surgery Laparoscopic innovation in surgical management of varicose veins |
| Trial Acronym |
SEVVS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pankaj Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Room No 62,Department of General Surgery,AIIMS Bhubaneswar
Sijua,Patrapada,Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9711090814 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pankaj Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Room No 62,Department of General Surgery, AIIMS Bhubaneswar
Sijua,Patrapada,Bhubaneswar
ORISSA
751019
India |
| Phone |
9711090814 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pankaj Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Room No 62,Department of General Surgery, AIIMS Bhubaneswar
Sijua,Patrapada,Bhubaneswar
ORISSA
751019
India |
| Phone |
9711090814 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
Sijua,Patrapada,Bhuabneswar,Odisha, India,751019 |
| 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 |
| Dr Pankaj Kumar |
All India Institute of Medical Sciences,Bhubaneswar |
Room No 62, Department of General Surgery,Sijua,Patrapada,Bhuabaneswar
Khordha
ORISSA |
09711090814
drpkushwaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences,Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
Laparoscopic Varicose vein Surgery |
Varicose veins will be operated laparoscopically
Total Duration - 2-3 hours |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients with varicose vein of lower limb planned for surgery |
|
| ExclusionCriteria |
| Details |
1. Patients with contraindication to spinal/general anasthesia
2. Refusal to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and feasibility of SEVVS |
Safety - upto 30 days
Feasibility - During surgery(2-3 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complications |
30 days |
| Quality of life |
six month |
| Recurrences |
Six months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| Date of Study Completion (India) |
27/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 vein is a disorder characterised by elongated, dilated and tortuous veins primarily affecting
the lower extremities. This condition typically involves malfunctional venous valves which results
in pooling of blood in lower extremities and venous insufficiency. Venous hypertension not only
causes cosmetic concerns but can also lead to discomfort, pain and complications such as skin
discoloration, venous ulcers, bleeding and thrombophlebitis. Over the years, an array of
treatment modalities has been developed, encompassing a spectrum from conservative
management strategies to more invasive surgical approaches and endovenous interventions.
Open surgical approaches involving saphenofemoral junction (SFJ) ligation, vein stripping and
ambulatory phlebectomy are frequently associated with postoperative sequelae such as pain,
discomfort, wound infections and paraesthesia Endovenous procedures (RFA, EVLA, EVTA etc) are
globally acknowledged as primary treatment modalities for managing varicose veins or addressing
clinical manifestation of venous pathology. Nevertheless, a significant constraint of these
interventions lies in their applicability in highly tortuous veins, requisite availability of specialised
equipment, necessary expertise and associated cost.
While subfascial endoscopic perforator surgery (SEPS) has an established role in laparoscopic
management of incompetent perforators, there is presently no laparoscopic technique
articulated for simultaneous treatment of saphenofemoral junction (SFJ) incompetence and
perforator incompetence in a single operative session. We propose a fully laparoscopic approach
for comprehensive management of varicose veins encompassing both precise identification and
targeted treatment of venous incompetence, thereby optimizing patient outcome. |