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1. “COMPARATIVE ANALYSIS OF ENDOVENOUS LASER
ABLATION VERSUS CONVENTIONAL SURGERY FOR THE
TREATMENT OF LOWER LIMB VARICOSE VEINS”
By
Dr. MANNAM VISWATEJA
P.G IN M.S GENERAL SURGERY
Under the guidance of
Dr. DEEPAK R CHAVAN SIR
ASSOCIATE PROFESSOR OF GENERAL SURGERY
B. L.D.E.(D.U.) SHRI B.M.PATIL MEDICALCOLLEGE, HOSPITAL &
RESEARCH CENTRE
VIJAYPUR 586103
KARNATAKA
2. INTRODUCTION
• Varicose veins are defined as dilated, tortuous, subcutaneous
veins >3mm in diameter measured in upright position with
demonstrable reflux.
• Varicose veins do not threaten life but are seldom disabling,
and causes considerable strain on medical care.
• It is the cause of morbidity and loss of precious work hours
and a significant financial burden on the health care system. It
is a penalty we pay for adoption of erect posture
3. • It effects 10-20% of population in western world but in india
its incidence is around 5-10%.
• They can be primary where the defect lies in the walls or
valves of superficial venous system/perforating veins.
• Secondary varicose veins are due to the obstruction in venous
flow such as deep venous thrombosis(DVT), pregnancy, and
tumors.
• However both conditions ultimately result in ambulatory
venous hypertension, subsequently activating inflammation
pathways mediated by leukocytes, chemokine as well as
cytokine expression, growth factors and metalloproteinases.
4. • Signs and symptoms associated with chronic venous
insufficiency(CVI) include heaviness, pain, edema,
hyperpigmentation, eczema, atrophy blanche,
lipodermatosclerosis and eventually ulcer formation entailing a
considerable reduction of the affected patients quality of life.
• The descriptive CEAP(Clinical-Etiology-Anatomical-
Pathophysiology) classification for chronic venous disorders is
widely used for clinical classification.
6. • Compression therapy is the most commonly applied treatment
and has proven effective. How ever early surgical
interventions has been associated with improved outcome.
• Surgical or interventional management involves elimination of
pathological epifascial reflux by endovenous thermal or non
thermal ablation, ultrasound-guided foam
sclerotherapy(UGFS) or high ligation and stripping.
• Recently, the use of minimally invasive endo-venous
interventions, including endovenous laser and foam
sclerotherapy has gained increasing attention due to lack of
open surgical incisions, the possibility to be carried out under
local/tumescent anesthesia and consequently , their lower post
operative morbidity.
7. • So far a large series of studies has demonstrated the efficiency
of thermal and non-thermal endovenous techniques in reflux
elimination in patients with axial venous reflex.
• However comparative studies on different types of endovenous
treatments and conventional surgery in postoperative clinical
outcomes are scarce.
8. AIMS AND OBJECTIVES OF THE STUDY:
The present study aimed at evaluating the treatment outcomes
of patients with CEAP class C2-C6 who underwent either EVLA or
conventional surgery of varicose veins. With a particular focus on
the recurrence rates, time taken for clinical improvement of
symptoms, time to complete ulcer healing if any, and potential
procedural complications, duration of hospital stay in B.M.PATIL
hospital, Vijayapura, Vijayapura district, Karnataka.
9. REVIEW OF LITERATURE:
• T.WALLACE et all (2018) studied patients with symptomatic
varicose veins due to great saphenous vein (GSV)
incompetence were followed up for 5yrs after enrollment in
RCT of either surgery or EVLA plus multiple evulsions.
Outcomes included : clinical recurrence, defined as new
varicose veins diameter greater than 3mm.Venous Clinical
Severity Score (VCSS); quality of life measured by means of
Short Form 36, EuroQol Five Dimensions (EQ-5DTM) and
Aberdeen Varicose Vein Questionnaire (AVVQ); patient
satisfaction ;and duplex ultrasound examination (DUS)
findings. They have concluded that EVLA was more effective
than surgery in preventing clinical recurrence
10. • ANKE A M BIMANS (2013) studied the anatomic success rate,
frequency of major complications, and quality-of-life improvement
of endovenous laser ablation (EVLA), ultrasound-guided foam
sclerotherapy (UGFS), and conventional surgery (CS), after 1-year
follow-up. A total of 240 consecutive patients with primary
symptomatic great saphenous vein reflux were randomized to
EVLA, UGFS, or CS, consisting of high ligation and short stripping.
Primary outcome was anatomic success defined as obliteration or
absence of the treated vein on ultrasound examination after 1year.
Secondary outcomes were complications, improvement of the
"C" class of the CEAP classification, and improvement
of disease-specific (Chronic Venous Insufficiency Quality-of-Life
Questionnaire) and general (EuroQol 5) quality-of-life
scores.Conclusion After 1-year follow-up, EVLA is as effective as
CS and superior to UGFS according to occlusion on ultrasound
duplex. Quality of life improves after treatment in all groups
significantly..
11. • Kilsoo yie (2021) studied the procedural efficacy
focusing on symptom characteristics and
improvement patterns in population with low grade
superficial venous reflux (C0-C3). 325 limbs from
279 patients were studied.After data adjusting 174
limbs (cyanoacrylate [CA] with UGFS n=87;
EVLAwith UGFS n=87) were matched and compared
to conventional surgery. It was found that minimally
invasive endovenous surgery with CA and EVLA
provides significant symptom improvement for
patients with low-grade CEAP classes.
12. • Ahmed M.M. Morshed et all(2018) conducted
a study comparing outcomes in patients who
either received EVLA or convenctional
surgery in egypt. They have concluded that
both the procedures have similar results in
regards to efficacy and recurrence rates. So
they have concluded that EVLA is better in
view of cosmetic reasons.
13. MATERIALAND METHOD :
• Study setting: All patients admitted in the Department
of surgery at B.L.D.E.(D.U)’S Shri B.M.Patil Medical
College Hospital and Research Centre, Vijayapura
between march 2022 to December 2024 and underwent
either endovenous laser ablation(EVLA) or conventional
surgery-high ligation with stripping with CEAP class C2-
C6.
• Study Period:
March 2022 – December 2024
• Study Design:
Prospective comparative study
14. Method of collection of data:
• This is a prospective comparative study of patients undergoing either
EVLA or conventional surgeries in B.L.D.E.(D.U)’S Shri B.M.Patil
Medical College Hospital and Research Centre.
• The period of study is from March 2022 to December 2024.
• All patients in IPD undergoing EVLA/conventional surgery will be
included in the study.
• A pretested structural proforma will be used to collect relevant
information for each individual patient selected.
15. • Demographic variables of subjects will be age , sex,
occupation, BMI, and any associated comorbidities will
be documented.
• Immediate post op pain scoring, duration of surgery
and post op complications like bruising and thermal
burns with EVLA and others will be documented.
• Detailed history of each individual patient will be
taken.
16. • Patients will be divided into two groups;
Randomization will be done
according to appropriate statistical
randomization methods, so that there is no
bias.
17. METHOD OF COLLECTION OF DATA
Cases will be selected consequently following the
inclusion and exclusion criteria
All eligible patients will be randomised according to
appropriate statistical methods to prevent biases.
Patients are then separated into two groups EVLA
(group A) or conventional surgery (group B).
18. • Written informed consent will be obtained
from all the patients with detailed explanation
of the procedure going to be performed on
them, the risk factors and complications
involved and the advantages and disadvantages
of the same.
• The duration of stay of each individual patient
post operation will be mentioned in the study.
19. • Visual analogue pain scores of each individual patient selected
will be included post operatively.
20. • Any other investigation will be done if
required based on history and other
complaints.
• Post op evaluation is done at one week,
6weeks, 3months and 6months.
21. INCLUSION CRITERIA
• Patients admitted in B.L.D.E .(D.U) Shri BM Patil medical
College and research Centre and undergoing varicose veins
surgery either EVLA or conventional surgery.
• Age >18yrs
• CEAP class C2-C6.
22. EXCLUSION CRITERIA
• Failure to obtain consent.
• Patients with endocrine, renal, hepatic or immunological
disease.
• Patients with haemodynamically relevant post thrombotic deep
venous obstruction.
• Peripheral vascular disease > or equal to stage 2 fontaine
classification.
• Or any wound infection if any
23. • GSV diameter more than 17mm.
• Patients with tortuous veins as it makes the
passage of endovenous device impossible.
24. RESEARCH HYPOTHESIS
• EVLA has less chances of recurrence, morbidity, hospital stay
and better long term outcomes when compared to conventional
surgeries
25. • STUDY DURATION: March 2022 to December 2024.
• SAMPLING:
With Anticipated Proportions of recurrence rate after surgical
procedure and EVLA procedure 23 % and 2.3% (ref) resp,. the
study would require a sample size of 35 per group. (i.e. a total
sample size of 70 assuming equal group sizes), to achieve a
power of 80% for detecting a difference in proportions between
two groups at a two sided p-value of 0.05. Sample size was
calculated using G* power 3.1.9.7
26. • Statistical Analysis:
• The data obtained will be entered in a Microsoft Excel
sheet, and statistical analysis will be performed using
statistical package for the social sciences ( Verson 20).
• Results will be presented as Mean±SD, counts and
percentages and diagrams.
• Follow up results will be compared using Repeated
measures of ANOVA/Friedman test.
• For normally distributed continuous variables between
two groups will be compared using Independent t test For
not normally distributed variables Mann Whitney U test
will be used. Categorical variables between two groups
will be compared using Chi square test/Fishers Exact test.
27. • .p<0.05 will be considered statistically
significant. All statistical tests will perform two
tailed.
28. INVESTIGATIONS/INTERVENTIONS
• There is no animal experiment involved in this study.
Investigations or interventions required in this study are
routine standardized procedures. After clinical evaluation with
history and complete examination following investigations
will be done.
Investigations :
● Complete blood count
● Urine routine
● Blood grouping and typing
● HIV And HBSAg and HCV
● Random blood sugar
29. ● Coagulation profile
● Colour Doppler of relevant limb
● Chest x-ray if relevant
● ECG if relevant
● Any other investigations if relavent.
30. REFERENCES
1. 1) Wallace T, El-Sheikha J, Nandhra S, Leung C, Mohamed A, Harwood A, Smith
G, Carradice D, Chetter I. Long-term outcomes of endovenous laser ablation
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Dec;105(13):1759-1767. doi: 10.1002/bjs.10961. Epub 2018 Aug 22. PMID:
30132797.
2. 2) Paravastu SC, Horne M, Dodd PD. Endovenous ablation therapy (laser or
radiofrequency) or foam sclerotherapy versus conventional surgical repair for
short saphenous varicose veins. Cochrane Database Syst Rev. 2016 Nov
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3. 3) Comparison of Laser Ablation, Foam Sclerotherapy and Surgery (CLASS) Trial
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