DR SREERAJ ASOK(PRESENTER)

DR SRINIVAS (MODERATOR)
DEPARTMENT OF SURGERY
BANGALORE BAPTIST HOSPITAL
RCT - RANDOMIZED CONTROLLED TRIAL

WHY RANDOMIZE ? reduces selection & allocation bias

TYPES OF RCTs – parallel—group (most common)

BLINDING / MASKING - prevent study participants, caregivers & outcome

assessors from knowing which intervention was
received
WHY THIS SPECIFIC RCT ? compared three interventions for great saphenous varicose veins

IS THIS RCT PUBLISHED IN A REPUTABLE JOURNAL ? (IMPACT FACTOR – 5.9)

WHAT IS IMPACT FACTOR – ____NUMBER OF CITATIONS______

NUMBER OF ARTICLES PUBLISHED

HIGHER IMPACT FACTOR = MORE CITATIONS /PUBLICATION => JOURNAL PUBLISHES

HIGH QUALITY ARTICLES
 AIM
 To compare the efficacy of surgery, EVLA and UGFS in
patients with primary symptomatic, uncomplicated great
saphenous varicose veins (Clinical Etiologic Anatomic
Pathophysio- logic (CEAP) clinical grade C2–C4).
• two participating university hospitals in Finland
• between November 2007 and May 2010
TYPE OF STUDY: RANDOMIZED (block
randomization with sealed envelopes )
INCLUSION CRITERIA
 unilateral symptomatic
uncomplicated varicose veins
(CEAP clinical classification
C2–C4)
 duplex ultrasound-verified
reflux in the GSV
 mean diameter of the GSV in
the thigh 5–10 mm
 age 20–70 years
EXCLUSION CRITERIA
 peripheral arterial disease
 lymphoedema
 BMI exceeding 40 kg/m2
 Pregnancy
 allergy to sclerosant or
lidocaine
 severe general illness
 Malignancy
 previous deep vein thrombosis
 coagulation disorder
 METHODS
primary outcome measures Secondary outcome measures
 1-year occlusion (or absence)  Perioperative pain measured
rate of GSV on routine duplex using a visual analogue scale
imaging (VAS) from 0 (no pain) to 10
 Changes in disease-specific (worst possible, unbearable,
quality of life according to the excruciating pain) at the time of
Aberdeen Varicose Vein discharge and at 1 week after
Severity Score (AVVSS) the procedure
 Diameter of the GSV 20 cm  Duration of sick leave
below the groin was also  Rate of complications
measured & compared with (haematoma, pigmentation,
preoperative values. thrombophlebitis and
paraesthesia).
 MAJORITY
EXCLUDED

WHAT IS A CONSORT DIAGRAM ? - a simple flow diagram

showing enrollment of subjects, allocation to treatment, disposition
status & how they are analysed in the trial.
 Surgery
 SFJ exposed in the groin & side branches ligated back to the
femoral vein.
 Retrograde invagination stripping of the GSV was done, usually
down to below the knee.
 Tumescent solution (450ml Ringer’s solution with 50 ml 1 per
cent lidocaine with adrenaline (epinephrine)) injected into the
tunnel of the stripped GSV.
 EVLA
 EVLA done under tumescent local anaesthesia injected
around the GSV under ultrasound guidance.
 Laser ablation carried out under duplex guidance.
 A pulsed mode, with a 1⋅5-s impulse and 12 W of energy,
was used routinely, with the aim of applying 70 J/cm GSV.
 EVLA catheter tip was positioned 1⋅5–2cm below the SFJ
using ultrasound guidance.
 UGFS
 Patient remains supine during treatment
 GSV was cannulated under ultrasound guidance, usually at
proximal thigh level and immediately below the knee.
 Sclerosant foam (Polidocanol 1 per cent and sodium
tetradecyl sulphate (STS)) was prepared with a double-
syringe technique with a sclerosant to air ratio of 1:2.
 At 1-month follow-up, duplex ultrasound done and, if reflux
observed, second treatment with foam carried out.
 Patients were seen again 4 weeks after the second treatment,
and need for possible third treatment checked by duplex
imaging.
 RESULTS

WHAT WAS THE BASELINE AVVSS SCORE ? WHY IS IT IMPORTANT ?

 GSV PATENCY 1 YEAR
AFTER SURGERY
• Occlusion rates superior with surgery & EVLA

• Occlusion rates with UGFS poor

• Occlusion rates with UGFS worse when GSV

diameter is more

• Twenty-six patients (34 per cent) in the UGFS

group received two treatments

• The difference between UGFS and the two other

treatments was significant (P < 0⋅001).

• 16 patients had additional treatment: four

patients (7 per cent) in the surgery group, one
patient (1 per cent) after EVLA and 11 patients (15
per cent) after UGFS (P = 0⋅009).
 AVVSS LOWER IN ALL 3 GROUPS AFTER 1
YEAR
• QoL assessed using the Aberdeen
Varicose Vein Scoring System

• All 3 groups fared better even at 1

year after therapy

• No statistically significant
difference BETWEEN the groups
 PAIN MEASURED ON A
VISUAL ANALOG SCALE
(1-10) AT DISCHARGE AND
1 WEEK POST SURGERY

• Pain after treatment - less after UGFS

than with surgery / EVLA, both at the
time of discharge, and after 1 week
• Sick leave - 12 days (surgery), 8 days
(EVLA) and 1 day (UGFS). (P < 0⋅001
between UGFS and the 2 other groups).
• Haematoma (62% surgery), 42 %
(EVLA) 20% (UGFS).
• Skin pigmentation - UGFS (67%)
surgery (5%) & EVLA (4%); P < 0⋅001 for
UGFS versus other 2 groups).
Key findings
 GSV reflux - rare at 1 year after surgery or EVLA
 GSV reflux after UGFS - 50% & GSV patent in 20%.
 Disease-specific QoL better in all groups post-op.
 No significant differences between the interventions.
 short-term advantages from UGFS
 no or minimal pain at 1 week
 recovery from intervention fastest
Effect of GSV diameter on outcome
 Occlusion rate after UGFS was associated with GSV
diameter
 < 40 % in GSVs of > 9mm
 75 % in GSVs of < 6 mm
 UGFS should not be recommended for veins >6 mm in
diameter
 STRENGTHS & LIMITATIONS
 Randomized
 Excellent follow-up, (96⋅3 per cent at 1 year).

 Relatively short follow-up.

 Long-term consequence of high reflux rate after UGFS ?
 Foam used was more concentrated (air to sclerosant ratio
2:1) than in other studies. The impact of this is unknown.
 Although UGFS has some short-term advantages in recovery,
and equivalent quality of life after 1year, longer follow-up may
reveal higher rate of recurrent/residual GSV reflux at 1 year
increases long-term risk of recurrence
 AVVSS
 The Aberdeen Varicose Vein Questionnaire - Preferred
Method of Rationing Patients for Varicose Vein Surgery
(SAGE JOURNALS DEC 2014 Vol 65 page(s): 205-209)
No significant correlation in AVVQ improvement compared to
baseline VCSS, VFI, GSV diameter. AVVQ improvement significantly
correlated at 3 wks and 3 months with their baseline values.
 The Aberdeen Varicose Vein Questionnaire, Patient
Factors and Referral for Treatment (European Journal of
Vascular and Endovascular Surgery Vol 46, Dec 2013)
The distribution of veins (unilateral vs. bilateral) must be adjusted for
when reporting AVVQ scores.
 Comparing EVLA, UGFS and conventional surgery for great
saphenous varicose veins (J Vasc Surg 2013 )

Objective: the anatomic success rate, complications and QOL after 1-year.
Methods: 240 patients with primary symptomatic great saphenous vein .
Primary outcome - anatomic success(obliteration of vein on USG after 1 yr)
Secondary outcomes were complications, improvement of the “C” class of the
CEAP classification, improvement of disease-specific QOL scores.

Results: After 1 year, the anatomic success rate was highest after EVLA
(88.5%), followed by CS (88.2%) and UGFS (72.2%) (P < .001).
omplication rate was low and comparable between treatment groups.

Conclusions: After 1-year follow-up, EVLA is as effective as CS and

superior to UGFS according to occlusion on ultrasound duplex and
Quality of life mproves after treatment in all groups significantly.
 Randomized clinical trial comparing EVLA, RFA, UGFS and
surgical stripping for GSV varicosities 3-year follow-up (2013)

Varicose Clinical Severity Score (VCSS), and quality of life (QOL).

Follow-up : clinical, duplex USG , VCSS and QOL questionnaires.

Results: At 3 years 8 RFA, 8 EVLA, 31 UGFS , 8 stripping of GSV recanalized

(>10 cm open refluxing GSV) (P < .01).
17 RFA, 24 EVLA, 20 UGFS and 22 stripping developed recurrent VV.
VCSS, SF-36, and Aberdeen QOL scores improved significantly in all the
groups with no difference between the groups.

Conclusions: All treatment modalities were efficacious and and resulted

in a similar improvement in VCSS and QOL. However, more
recanalization and reoperations were seen after UGFS.
THANK YOU