Multicentre Randomised Controlled Trial of Compression Therapy Following Endothermal Ablation (COMETA)
Phase: NA
Conditions: Varicose Veins
Sponsor: Imperial College London

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Multicentre Randomised Controlled Trial of 
Compression Therapy following Endovenous Thermal 
Ablation of Varicose Veins 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
 
FULL TITLE 
 
A multicentre randomised controlled trial of compression therapy following 
endovenous thermal ablation of varicose veins. 
 
SUMMARY 
 
This study will be looking at the effect of compression therapy in patients having 
endovenous treatment for truncal incompetence of their varicose veins using either 
radiofrequency ablation (RFA) or endovenous laser therapy (EVLT). Patients will be 
randomised to either the compression group (group A) or the no compression group 
(group B).  
 
The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well 
as the cost effectiveness of each intervention will be assessed. 
 
OBJECTIVES 
 
• 
Primary Objective 
 
Patient’s pain score for the first 10 days post-procedure using the visual 
analogue scale (VAS)  
 
• 
Secondary Objective 
 
The secondary objectives would be to compare the two treatment groups with 
respect to: 
o The quality of life scores at baseline, 2 weeks and 6 months using the 
EQ-5D, AVVQ and CIVIQ scores 
o The clinical change using the VCSS at baseline, 2 weeks and 6 
months    
o The degree of bruising and phlebitis at 2 weeks and 6 months 
o The patient compliance with the intervention  
o The time taken to return to work and normal activities 
o Occlusion rates at 6 months 
o Comparison of the cost effectiveness of the intervention  
 
Background 
 
Varicose veins are common and are known to affect approximately one third of the 
population1. Chronic venous disease (CVD) has been shown to have a negative 
impact on the quality of life of patients and treatment of varicose veins has been 
demonstrated to lead to improvement in the quality of life of patients2-4. Over the past 
decade, new endovenous techniques have been introduced and these are felt to be 
cost-effective, especially, when performed in an outpatient or ‘office-based’ setting5. 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
 
There is currently uncertainty about the use of compression stockings following 
treatment of varicose veins. In their consensus statement in 2008, the International 
Union of Phlebology (IUP) stated that there is good evidence for using compression 
in certain clinical indications6. These include the management of telangiectasia after 
sclerotherapy, varicose veins in pregnancy, prevention of thromboembolism and 
healing of ulcers. However, a few questions remain unanswered, such as the length 
of treatment and level of compression to be used6. The Society for Vascular Surgery 
and the American Venous Forum recommend using compression stockings post-
operatively for 1 week to prevent haematoma formation, pain and swelling7. The 
2013 NICE Guidelines on Varicose Veins in the Legs recommended the use of 
compression hosiery for no more than 7 days after interventional treatment for 
varicose veins8. However, due to current uncertainty of compression bandaging or 
hosiery compared to no compression after interventional treatment for varicose 
veins, the NICE Guideline Development Group have advocated further research to 
evaluate the clinical and cost effectiveness of this post-procedure intervention8. The 
guidelines also suggested looking into the length of time compression bandaging 
should be worn if it shown to be beneficial8. 
 
Several researchers have looked into the practice of using compression after venous 
ablation. In a survey of the management of varicose veins by the members of the 
Vascular Society of Great Britain and Ireland, Edwards et al. found that the majority 
of surgeons used bandages post-operatively, with 49% using elastic bandages9. The 
literature on the use of compression stockings following treatment of varicose vein is 
limited. 
 
Between December 2006 and February 2008, Bakker and colleagues conducted a 
prospective randomised controlled trial on the use of compression stockings after 
endovenous laser ablation of the great saphenous vein10. One hundred and nine 
patients were approached with 93 finally randomised to use compression stockings 
for 2 days (Group A) and 7 days (Group B), respectively. All patients were followed 
up for 3 months post-treatment and the visual analogue scale (VAS) for pain was 
recorded at 48 hours, 1 week and 6 weeks. A physical examination and quality of life 
was assessed at 1 week and 6 weeks. Occlusion rate at the 3 month point was also 
evaluated. Physical function and vitality was shown to be significantly better in group 
B at 1 week follow-up, but there was no statistically significant difference at 6 weeks. 
At 1 week, it was also noted that the VAS score in group B (VAS score 2.0 ± 1.1) 
was significantly lower than in patients wearing compression stockings for 48 hours 
(VAS score 3.7 ± 2.1) (p≤0.001)10. No significant difference was, however, observed 
at 6 weeks post-procedure. Limitations of the study include the high drop out of the 
trial (40 out of the initial 109 approached) and the absence of any phlebectomies or 
sclerotherapy in the patients.   
 
Elderman et al. carried out a randomised trial to assess the effect of compression 
stockings after endovenous laser therapy (EVLT) for great saphenous vein 
incompetence11. Patients’ reported pain scores and quality of life scores was 
evaluated on the day of the procedure, 2-3 days afterwards and 2-6 weeks post-
procedure. A total of 111 patients were randomised to stockings (n=55) and no 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
stockings (n=56). There was a statiscally significant difference in the pain scores in 
favour of the stockings group up to day 7, but this difference was no longer present 
by week 6. There was also a greater use of analgesia in patients in the no stockings 
group compared to patients wearing stockings (p<0.05). In addition, patients wearing 
stockings reported a statistically significantly higher score of satisfaction at 2 days 
(4.44 vs 4.15) and at 6 weeks (4.59 vs 4.18). The absolute difference was, however, 
small. Two notable limitations of the study were the high level of drop outs (16 from 
each group) and the absence of any blinding. 
 
Hamel-Desnos et al. undertook a randomised controlled trial looking at the effect of 
compression in patients receiving foam sclerotherapy of the saphenous vein12. They 
noted that patients with compression had similar pain and quality of life scores to 
patients not wearing any compression. They concluded that additional use of 
compression had no impact on the effectiveness of obliteration of veins, satisfaction 
scores, symptoms and quality of life, and that further controlled trials was needed to 
answer the question of whether using compression results in any difference to the 
outcome of varicose vein procedures.  
 
We, therefore, propose to undertake a multicentre randomised study looking at the 
effect of compression therapy after endovenous thermal ablation. 
 
Description 
 
This will be a multicentre randomised clinical trial looking at the impact of wearing or 
not wearing compression stocking following endothermal ablation (either endovenous 
laser treatment (EVLT) or radiofrequency ablation (RFA)) of incompetent truncal 
veins. If clinically indicated, patients will receive adjuvant treatment (e.g., concurrent 
phlebectomies or foam injection). 
 
Patients will be randomised to group A (compression) and group B (no compression). 
Only the use of compression will be randomised while the decision as to which 
treatment to use will be at the discretion of the clinical team. 
 
Target Population 
 
Patients referred for treatment of symptomatic varicose veins will be recruited if they 
are found to have primary great saphenous (GSV) or small saphenous vein (SSV) 
incompetence on colour duplex scan. 
 
Inclusion Criteria 
 
• 
Adults over 18 years of age 
• 
Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex 
• 
Recurrent varicose veins (if suitable for endothermal treatment) 
Exclusion Criteria  
 
• 
Current DVT 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
• 
Arterial disease (ABPI<0.8) 
• 
Vein diameter < 3mm 
• 
Patient who are unwilling to participate 
• 
Inability or unwillingness to complete questionnaires  
 
Intervention 
 
Patients will be randomised to have compression (group A) or no compression 
(group B). The compression therapy used will be Class II compression stockings. 
The treatment offered will be endothermal ablation (either endovenous laser 
treatment (EVLT) or radiofrequency ablation (RFA)) of incompetent truncal veins. 
Adjuvant 
treatment 
to 
tributaries 
(e.g., 
concurrent 
phlebectomy 
or 
foam 
sclerotherapy) will be carried out, if indicated.  
 
Patients randomised to group A will be asked to wear compression stockings for 1 
week.  
 
Patients randomised to group B and undergoing endothermal ablation only will not be 
provided with any compression. However, if they receive adjuvant treatment to their 
tributaries, they will be provided with bandages to wear for 24 hours only, with no 
further compression afterwards.  
 
At baseline, patients will be asked to fill quality of life questionnaires (EQ-5D, AVVQ 
and CIVIQ) and will have their clinical scores assessed (CEAP and VCSS). On 
discharge after their varicose vein intervention, they will then be provided with a diary 
to record their post-procedural pain every day for 10 days using a validated visual 
analogue scale (VAS) as well as to record when they return to their normal activities 
and are back to work. They will also be asked to attend a follow-up in 2 weeks and at 
6 months.  
 
Patients’ GP will also be sent a letter to inform them of their patient’s participation in 
the study. 
 
Follow-up 
 
Patients will be followed up in the outpatient clinic at 2 weeks and 6 months. 
 
Follow-up at 2 Weeks 
At the 2 weeks’ follow-up, the diary containing details of the pain scores and how 
soon patients were able to return to normal activities/work will be collected. In 
addition, patients will be asked about any bruising or phlebitis they have had in the 
two weeks after their procedure and how compliant they have been with the 
compression. They will be examined and the Venous Clinical Severity Score (VCSS) 
will be recorded. They will also be asked to fill in the EQ-5D, AVVQ and CIVIQ 
scores. 
 
Follow-up at 6 Months 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
At the 6 months follow-up, patients will be examined and their VCSS will be 
recorded. They will also be asked to fill the EQ-5D, AVVQ and the CIVIQ scores. 
They will have a venous Duplex scan to determine occlusion of the treated vein. 
 
Sample Size and Study Duration 
 
We estimated the sample size needed to observe a difference of at least 10mm in 
the VAS score, with a standard deviation of 20mm. With power at 90% and 5% 
significance equivalence, we would need to recruit 174 patients (87 per group).  
 
Previous studies looking at compression stockings have shown drop out rates close 
to 37% at 3 months10. Therefore, if we estimate a drop out rate of about 50% by 6 
months, we would need to recruit at least 348 patients. If we recruit at least 7 
patients per week, this will be approximately a total of 364 patients that could 
potentially be randomised over the year. With 6 months follow-up, therefore, the 
study will be running for 18 months with a target recruitment of 350 patients.  
 
Settings 
 
Two hospital trusts in London will be recruiting patients for the study. These will be 
the: 
1. Imperial College NHS Trust  
2. North West London Hospitals NHS Trust 
 
ETHICAL ARRANGEMENTS 
 
Ethical approval will be sought from a Regional Research Ethics Committee as per 
the National Research Ethics Service. Patients will be screened by Roshan Bootun 
(or another research fellow), who is also members of the direct care team, and 
patients thought eligible will be provided with information material about the trial and 
varicose veins and its treatments.  
They will be invited to attend for their varicose vein procedures another day and will 
have until then to consider their participation into the trial (more than 24 hours to 
consider).  
On the day of their procedure, they will be asked by Roshan Bootun (or another 
research fellow) to confirm their consent by providing a written consent prior to 
participating in the trial.  
The National Health Service (NHS) Trust Research and Development approval will 
also be sought prior to starting the trial.  
 
DATA HANDLING & DISSEMINATION OF RESULTS 
All patient data will be anonymised and stored on a password protected access 
database under the guidelines of the Data Protection Act 1998. Patient records will 
be kept on paper in the form of the diary card questionnaires and clinical scoring 
sheets. These will be kept in a locked filling cabinet at the and stored at the Charing 
Cross Hospital for 10 years in accordance with the Imperial College Trust Policy. 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
Data and study findings will be presented locally within the hospital, as well as 
national and international peer reviewed presentations and peer-reviewed journals. 
Criteria for Electively Stopping the Trial or Other Research Prematurely  
The trial may be stopped prematurely due to loss of equipoise or any major adverse 
effect as a result of treatment in any of the treatment arms. 
Adverse events 
No significant adverse events are expected. 
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study 
subject. 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence 
or effect that: 
·         Results in death 
·         Is life-threatening – refers to an event in which the subject was at risk of 
death at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe 
·         Requires hospitalisation, or prolongation of existing inpatients’ 
hospitalisation 
·         Results in persistent or significant disability or incapacity 
·         Is a congenital anomaly or birth defect 
 
REPORTING PROCEDURES 
All adverse events should be reported. 
Depending on the nature of the event the reporting procedures below should be 
followed. 
Any questions concerning adverse event reporting should be directed to the Chief 
Investigator in the first instance.  
Adverse Events (AE) 
All such events, whether expected or not, should be recorded.  
  
Serious Adverse Events (SAE) 
An SAE form should be completed and faxed to the Chief Investigator within 24 
hours.   
 All SAEs should be reported to the Research Ethical Committee where in the 
opinion of the Chief Investigator, the event was: 
·         ‘related’, ie resulted from the administration of any of the research procedures; 
and 
·         ‘unexpected’, ie an event that is not listed in the protocol as an expected 
occurrence 
  
Reports of related and unexpected SAEs should be submitted within 15 days of the 
Chief Investigator becoming aware of the event, using the NRES SAE form for non-
IMP studies.  
Local investigators should report any SAEs as required by their Local Research 
Ethics Committee, Sponsor and/or Research & Development Office. 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
In the event of any harm to participants in the trial, Imperial College holds Public 
Liability (“negligent harm”) and Clinical Trial (“non-negligent harm”) insurance policies 
which apply to this trial. 
ETHICS APPROVAL 
 
The Chief Investigator has obtained approval from the National Research Ethics 
Service (NRES) Committee - London (Fulham).  The REC reference is 15/LO/0181. 
The study protocol will be submitted for Site Specific Assessment (SSA) at each 
participating NHS Trust.  The Chief Investigator will require a copy of the Trust R&D 
approval letter before accepting participants into the study.  The study will be 
conducted in accordance with the recommendations for physicians involved in 
research on human subjects adopted by the 18th World Medical Assembly, Helsinki 
1964 and later revisions. 
CONSENT  
 
Consent to enter the study will be sought from each participant only after a full 
explanation has been given, an information leaflet offered and time allowed for 
consideration. Signed participant consent will be obtained. The right of the participant 
to refuse to participate without giving reasons will be respected. After the participant 
has entered the study the clinician remains free to give alternative treatment to that 
specified in the protocol at any stage if he/she feels it is in the participant’s best 
interest, but the reasons for doing so will be recorded. In these cases the participants 
remain within the study for the purposes of follow-up and data analysis. All 
participants are free to withdraw at any time from the protocol treatment without 
giving reasons and without prejudicing further treatment. 
 
CONFIDENTIALITY 
 
The Chief Investigator will preserve the confidentiality of participants taking part in 
the study and is registered under the Data Protection Act. 
INDEMNITY 
 
Imperial College London holds negligent harm and non-negligent harm insurance 
policies which apply to this study. 
 
SPONSOR 
 
Imperial College London act as the main Sponsor for this study. Delegated 
responsibilities will be assigned to the NHS trusts taking part in this study.   
 
FUNDING 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
There are no funders for this study.  
 
AUDITS  
 
The study may be subject to inspection and audit by Imperial College London under 
their remit as sponsor and other regulatory bodies to ensure adherence to GCP and 
the NHS Research Governance Framework for Health and Social Care (2nd edition).  
 
Reference: 
 
1. 
Evans CJ, Fowkes FG, Ruckley CV and Lee AJ. Prevalence of varicose veins 
and chronic venous insufficiency in men and women in the general population: 
Edinburgh Vein Study. Journal of epidemiology and community health. 1999; 53: 
149-53. 
2. 
Smith JJ, Garratt AM, Guest M, Greenhalgh RM and Davies AH. Evaluating 
and improving health-related quality of life in patients with varicose veins. J Vasc 
Surg. 1999; 30: 710-9. 
3. 
MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV and Bradbury AW. 
The effect of long saphenous vein stripping on quality of life. J Vasc Surg. 2002; 35: 
1197-203. 
4. 
Biemans AA, Kockaert M, Akkersdijk GP, et al. Comparing endovenous laser 
ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose 
veins. J Vasc Surg. 2013; 58: 727-34.e1. 
5. 
van den Bos R, Arends L, Kockaert M, Neumann M and Nijsten T. 
Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 
2009; 49: 230-9. 
6. 
Partsch H and Baccaglini U. Consensus conference on sclerotherapy of lower 
limbs varicose veins. Journal des maladies vasculaires. 1995; 20: 134-5. 
7. 
Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with 
varicose veins and associated chronic venous diseases: clinical practice guidelines 
of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 
2011; 53: 2s-48s. 
8. 
Marsden G, Perry M, Kelley K and Davies AH. Diagnosis and management of 
varicose veins in the legs: summary of NICE guidance. BMJ (Clinical research ed). 
2013; 347: f4279. 
9. 
Edwards AG, Baynham S, Lees T and Mitchell DC. Management of varicose 
veins: a survey of current practice by members of the Vascular Society of Great 
Britain and Ireland. Annals of the Royal College of Surgeons of England. 2009; 91: 
77-80. 
10. 
Bakker NA, Schieven LW, Bruins RM, van den Berg M and Hissink RJ. 
Compression stockings after endovenous laser ablation of the great saphenous vein: 
a prospective randomized controlled trial. European journal of vascular and 
endovascular surgery : the official journal of the European Society for Vascular 
Surgery. 2013; 46: 588-92. 
11. 
Elderman JH, Krasznai AG, Voogd AC, Hulsewé KWE and Sikkink CJJM. 
Role of compression stockings after endovenous laser therapy for primary varicosis. 
Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2014. 
12. 
Hamel-Desnos CM, Guias BJ, Desnos PR and Mesgard A. Foam 
sclerotherapy of the saphenous veins: randomised controlled trial with or without 
compression. European journal of vascular and endovascular surgery : the official 
journal of the European Society for Vascular Surgery. 2010; 39: 500-7. 
  

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
 
 
 
 
APPENDIX 1: Quality of Life Questionnaire 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
 
 
 
 
 
 
 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
Appendix 2: Aberdeen Varicose Vein Questionnaire 
 
 
 
1. 
Please draw in your varicose veins in the diagram(s) 
below:- 
 
 
      Legs viewed 
 
 
 
 
 
       Legs viewed 
 
        from front 
 
 
 
 
 
         from back 
 
2. 
In the last two weeks, for how many days did your 
varicose veins cause you pain or ache? 
(Please tick one box for each leg) 
R Leg 
L Leg 
None at all 
 
 
 
Between 1 and 5 days 
 
 
 
Between 6 and 10 days 
 
 
 
For more than 10 days 
 
 
 
 
3. 
During the last two weeks, on how many days did you take 
painkilling tablets for your varicose veins? 
(Please tick one box for each leg) 
R Leg 
L Leg 
None at all 
 
 
 
Between 1 and 5 days 
 
 
 
Between 6 and 10 days 
 
 
 
For more than 10 days 
 
 
 
 
 
 
 
YOUR VARICOSE VEINS 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
4. 
In the last two weeks, how much ankle swelling have you 
had? 
 
(Please tick one box)                                                            None at all  
 
Slight ankle swelling 
 
 
Moderate ankle swelling (eg. causing you 
to sit with your feet up whenever possible) 
 
  
Severe ankle swelling  (eg. causing you 
 difficulty putting on your shoes) 
 
       
5. 
In the last two weeks, have you worn support stockings or 
tights? 
 (Please tick one box for each leg) 
R Leg 
L Leg 
No 
 
 
 
 
Yes, those I bought myself without 
a doctor's prescription 
 
 
 
 
Yes, those my doctor prescribed for 
me which I wear occasionally 
 
 
 
 
Yes, those my doctor prescribed for 
me which I wear every day 
 
 
 
 
6. 
In the last two weeks, have you had any itching in 
association with your varicose veins? 
 (Please tick one box for each leg) 
R Leg 
L Leg 
No 
 
 
 
Yes, but only above the knee 
 
 
 
Yes, but only below the knee 
 
 
 
Both above and below the knee 
 
 
 
 
7. 
Do you have purple discolouration caused by tiny blood 
vessels in the skin, in association with your varicose 
veins? 
(Please tick one box for each leg) 
R Leg 
L Leg 
No 
 
 
 
Yes 
 
 
 
 
8. 
Do you have a rash or eczema in the area of your ankle? 
(Please tick one box for each leg) 
R Leg 
L Leg 
No 
 
 
 
 
Yes, but it does not require any treatment  
from a doctor or district nurse 
 
 
 
 
Yes, and it requires treatment from  
my doctor or district nurse 
 
 
 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
9. 
Do you have a skin ulcer associated with your varicose 
veins? 
(Please tick one box for each leg) 
R Leg 
L Leg 
No 
 
 
 
Yes 
 
 
 
 
10. 
Does the appearance of your varicose veins cause you 
concern? 
(Please tick one box)                                                                        No 
 
 
Yes, their appearance causes 
me slight concern 
 
 
Yes, their appearance causes  
me moderate concern 
 
  
Yes, their appearance causes  
me a great deal of concern 
 
  
11. 
Does the appearance of your varicose veins influence 
your choice of clothing including tights? 
           (Please tick one box)                                                                         No 
 
Occasionally 
 
Often 
 
Always 
 
 
12. 
During the last two weeks, have your varicose veins 
interfered with your work/ housework or other daily 
activities? 
  (Please tick one box)                                                                          No 
 
 
I have been able to work but my work  
has suffered to a slight extent 
 
 
 I have been able to work but my work  
has suffered to a moderate extent 
 
 
My veins have prevented me from  
working one day or more 
 
 
13. 
During the last two weeks, have your varicose veins 
interfered with your leisure activities (including sport, 
hobbies and social life)? 
(Please tick one box)                                                                          No 
 
 
Yes, my enjoyment has suffered  
to a slight extent 
 
 
Yes, my enjoyment has suffered 
to a moderate extent 
 
 
Yes, my veins have prevented me taking  
part in any leisure activities 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
 
Appendix 4: Clinical assessment of Varicose Veins 
 
 
 
 
 
 
 
Hospital Number---------------------------  
 
MALE  
FEMALE 
 
 
 
 
 
 
 
 
Date of birth--------------------------------- 
 
 
 
 
 
 
 
Age ----------------------------------------- 
 
Occupation---------------------------------- 
 
 
 
 
Date------------------------------------------  
 
Past Medical History 
 
 
 
 
Yes  
No 
 
 
 
 
Yes  
No
 
 
Bleeding disorder 
 
  
   
 
IHD 
 
 
  
  
DVT/PE 
 
 
 
  
   
 
Leg ulcers 
 
 
 
  
Diabetes 
 
 
  
  
 
Hypertension  
  
  
 
Medications 
----------------------------------------------------------------------------------------------------------------------
-------------------------------- 
 
Previous treatment to Varicose Veins 
 
Side 
Site 
Date 
Treatment type 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 5: Pre Operative Clinical Assessment 
Score 
Definition 
0 
Asymptomatic 
1 
Symptomatic, but able to carry out usual activities with out compressive 
therapy 
2 
Able to carry out usual activities only with compressive therapy and/or 
limb elevation 
3 
Unable to carry out usual activities even with compression and/or 
elevation 
 
Usual activities = patients activities before the onset of disability due to 
venous disease 
 
 
 
 
 
 
 
 
 
Number of 
Pregnancies 
 
Weight/ Kg 
 
BMI>30 
Yes 
No 
OCP or HRT 
Yes 
No 
Smoker 
Yes 
No 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
Appendix 6: Venous Clinical Severity Score (VCSS) 
 Please indicate right or left leg or bilateral (R, L or B) 
 
Absent 
Mild 
Moderate 
Severe 
Pain 
None 
Occasional, non/ 
no analgesia 
restricting 
With moderate 
activity, 
occasional 
analgesia 
Daily, severe 
limitations, 
regular analgesia 
Varicose 
veins>4mm 
None 
Few 
Multiple GSV 
Extensive GSV 
and LSV 
Venous 
oedema 
None 
Evening/ankle 
Afternoon/ 
above knee 
Morning/requiring 
elevation 
Skin 
pigmentation 
None 
Limited and 
old/brown 
Diffuse lower 
third/ purple 
 
Wide/ purple 
 
Inflammation 
None 
Mild cellulitis in 
marginal area 
Moderate 
involving most 
of gaiter area  
Severe cellulitis 
or significant 
eczema 
Induration 
None 
 Focal <5cm 
Medial or 
lateral less 
than lower 1/3 
1/3 of lower leg 
or more 
Number of 
active ulcers 
0 
1 
 
 
2 
 
 
3 
 
 
Active ulcer 
duration 
None 
<3 months 
>3 months  
<12 months 
>12 months 
Active ulcer 
diameter( cm) 
None 
<2 
2-6 
>6 
Compression 
Not used or 
non compliant 
Intermittent use 
Stockings 
worn most 
days 
Stockings worn 
daily 
 
Total 
 
 
 
 
 
 
Appendix 7: Clinical-Etiology-Anatomy-Pathophysiology (CEAP Classification) 
Clinical 
 
0 
1A 
1S 
2A 
2S 
3A 
3S 
4aA 
4aS 
4bA 
4bS 
5A 
5S 
6 
Etiology 
 
Congenital 
Primary 
Secondary 
No venous cause identified 
Anatomy 
 
Superficial 
Deep 
Perforating 
No venous location identified 
Patholog
y 
 
Reflux 
Obstruction 
Both 
No venous pathology identified 
 
Class 0 No visible or palpable veins 
Class 1 Telangiectasia, reticular veins  
 
Class 5 Skin changes and healed 
ulceration 
Class 2 Varicose Veins 
 
 
Class 6 Active venous ulcers 
Class 3 Oedema without skin changes 
Class 4 Skin changes ascribed to venous disease 
 
A= Asymptomatic 
 
4a) Pigmentation or eczema 
 
 
S= Symptomatic 
 
4b) Lipodermatoscerosis or atrophie blanche  

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
Appendix 8 
C I V I Q-14 
SELF-QUESTIONNAIRE PATIENTS 
In English language for UK 
 
 
Many people complain of leg pain. We would like to find out how often these 
leg problems occur and to what extent they affect the everyday lives of those 
who suffer from them. 
 
Below you will find a list of symptoms, sensations or types of discomfort that 
you may be experiencing and which may make everyday life hard to bear to a 
greater or lesser extent. For each symptom, sensation, or type of 
discomfort listed, we would like you to answer in the following way: 
 
Please indicate if you have experienced what is described in each sentence, 
and if the answer is ‘yes’, how intense it was. There are five possible 
answers, and we would like you to circle the one which best describes your 
situation. 
 
 
 
Circle 1 
if you feel the symtom, sensation of discomfort 
described does not apply to you 
 
Circle 2, 3, 4 or 5 
 
if you have felt it to a greater or lesser extent 
 
 
 
 
 
 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
QUALITY OF LIFE WITH VENOUS INSUFFICIENCY 
 
 
1)  During the past four weeks, have you had any pain in your ankles or legs, and how 
severe has this pain been? 
Circle the number that applies to you. 
 
No  
pain 
Slight  
pain 
Moderate 
pain 
Considerable 
pain 
Severe 
pain 
 
 
 
 
 
1 
2 
3 
4 
5 
 
 
 
 
2)  During the past four weeks, how much trouble have you experienced at work or 
during your usual daily activities because of your leg problems? 
Circle the number that applies to you. 
 
No trouble 
Slight trouble 
Moderate trouble 
Considerable 
trouble 
Severe trouble 
 
 
 
 
 
1 
2 
3 
4 
5 
 
 
 
 
3)  During the past four weeks, have you slept badly because of your leg problems, and 
how often? 
Circle the number that applies to you. 
 
Never 
Rarely 
Fairly 
often 
Very  
often 
Every 
night 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
 
 
 
 
During the past four weeks, how much trouble have you experienced 
carrying out the actions and activities listed below because of 
your leg problems? 
For each statement in the table below, indicate how much trouble you 
have experiened by circling the number chosen. 
 
 
No trouble 
Slight trouble 
Moderate 
trouble 
Considerable 
trouble 
Could not  
do it 
4)  Climbing several 
flights of stairs 
1 
2 
3 
4 
5 
5)  Crouching, 
Kneeling down 
1 
2 
3 
4 
5 
6)  Walking at a 
brisk pace 
1 
2 
3 
4 
5 
7)  Going out for 
the evening, going 
to a wedding, a 
party, a cocktail 
party… 
1 
2 
3 
4 
5 
8)  Playing a sport, 
exerting yourself 
physically 
1 
2 
3 
4 
5 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
  
Leg problems can also affect your mood. How closely do the following 
statements correspond to what you have felt during the past four 
weeks? 
 
For each statement in the table below, circle the number that applies 
to you. 
 
 
 
Not at all 
 
A little 
 
 
Moderately 
 
A lot 
 
Completely  
 
9)  I have felt 
nervous/tense 
1 
2 
3 
4 
5 
10)  I have felt I 
am a burden 
1 
2 
3 
4 
5 
11)  I have felt 
embarrassed about 
showing my legs 
1 
2 
3 
4 
5 
12)  I have become 
irritated easily 
1 
2 
3 
4 
5 
13)  I have felt as if 
I am handicapped 
1 
2 
3 
4 
5 
14)  I have not felt 
like going out 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
Appendix 9. Patient Diary 
 
Please indicate at what stage you were able to return to work and your normal daily 
activities (the activities you were able to do prior to treatment).  
 
Please also indicate the day when you stopped wearing the compression stockings (if 
provided). 
 
(Please tick one box) 
 
 
Day I was able to 
resume my normal 
activities 
Day I returned to 
work  
Day I stopped wearing 
compression 
stockings (if provided) 
Day of surgery 
 
 
 
Day after surgery 
 
 
 
2 days after surgery 
 
 
 
3 days after surgery 
 
 
 
4 days after surgery 
 
 
 
5 days after surgery 
 
 
 
6 days after surgery 
 
 
 
7 days after surgery 
 
 
 
8 days after surgery 
 
 
 
9 days after surgery 
 
 
 
10 days after surgery 
 
 
 
>10 days after surgery 
 
 
 
 
 
 
 
 
Please return to: 
Professor Alun Davies 
Academic Department of Vascular Surgery  
Floor 4 East 
Charing Cross Hospital 
Fulham Palace Road 
London 
W6 8RF 
Tel.: 02033117320 
 
 
 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
Appendix 10. Patient Pain Diary (VAS) 
Please put a mark on the line to indicate your maximum pain score on each day. 
Please also write a score from 0 to 10 for your maximum pain on each day. 
Example: If your pain score on day 4 is roughly about 5 over 10 (10 being the worst pain 
imaginable), you might want to indicate it as below: 
Day 4 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0  
 
10 
 
 
 
Study Diary: 
(0 = no pain and 10 = worst pain imaginable) 
Day 0 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0  
 
10 
 
Day 1 
No pain 
 
 
 
 
 
Worst pain 
imaginable 
 
 
0  
 
10 
 
Day 2 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0  
 
10 
 
Day 3 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0  
 
10 
 
Day 4 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0  
 
10 
 
Day 5 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0  
 
10 
 
Day 6 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0  
 
10 
 
Day 7 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0  
 
10 
 
Day 8 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0  
 
10 
 
Day 9 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0 
 
 
10 
 
Day 10 
No pain 
 
 
 
 
Worst pain 
imaginable 
 
 
0 
 
 
10 
 
| 
5 

 
Multicentre RCT of Compression Therapy following Endovenous Thermal Ablation v1.7 (19 June 2015) 
Symptomatic patients with varicose vein reflux > 
0.5 seconds on venous Duplex 
Appendix 11. Trial Flowchart 
 
Patients undergo endovenous thermal ablation 
(either radiofrequency ablation or laser therapy) 
2 weeks: diary returned and follow-up in clinic 
with VCSS, AVVQ, CIVIQ and EQ-5D  
Patients discharged home with diary to fill 
(recording pain scores, time to return to normal 
activities/work, complications and compliance) 
Consenting patients complete VCSS, AVVQ, 
CIVIQ and EQ-5D 
Randomisation 
No Compression Group – Group B 
Patients discharged home without any 
compression  
Compression Group – Group A 
Patients discharged with compression 
stockings to wear for 1 week 
6 months: follow-up in clinic with VCSS, AVVQ, 
CIVIQ and EQ-5D as well as venous Duplex  
Analysis of results and cost evaluation