Comparison of a compression for seven days or overnight after endovenous radiofrequency ablation of superficial vein: A randomized controlled trial

Abstract

Objective

To compare the efficacy of compression stockings worn for 7 days or overnight after EVRFA.

Methods

A single-centre, prospective, non-inferiority randomised controlled trial. The study included patients with clinical class C2–C4 chronic venous disease who underwent endovenous radiofrequency ablation (EVRFA) at Chulabhorn Hospital between October 2021 and October 2023. Sixty patients were assigned to wear the overnight compression group (n = 30) or for the 7-day compression group (n = 30). The primary outcome was targeted vein obliteration at 12 weeks. The secondary outcome measures were the revised Venous Clinical Severity Score (r-VCSS), Aberdeen Varicose Veins Severity Score (AVSS), pain score, complications and patient satisfaction.

Results

At 12 weeks, both groups had a 100% target vein occlusion rate. There was no statistically significant difference in the r-VCSS, AVSS, patient satisfaction score, complications or pain score at day 1, day 14 and 12–16 weeks after the procedure. Overnight compression improved r-VCSS significantly.

Conclusion

Overnight compression was non-inferior to compression for 7 days after EVRFA.

Keywords

Compression therapy chronic venous insufficiency endovenous radiofrequency ablation endovenous thermal ablation Thailand

What this paper adds

Compression therapy is routinely used in patients following endovenous radiofrequency ablation but there was debated on duration and benefit of compression. Furthermore, the compliance of patients is quite poor and a shorter necessary compression time would be welcomed by patients. This randomised controlled, non-inferiority trial compared between 7-day compression and overnight compression after procedure. There was no significant difference in target vein occlusion, quality of life, venous severity score and pain score.

Introduction

Chronic venous disease is common, affecting 40%–80% of people worldwide.¹ Endovenous approaches, including thermal and nonthermal techniques, have become the preferred treatments since the advent of minimally invasive techniques.² The American Venous Forum, European Society of Vascular Surgery and the National Institute of Health and Care guidelines recommend compression therapy after endovenous ablation of superficial venous insufficiency.^2–4 Compression after endothermal ablation is frequently used to assist in target vein occlusion and to minimise pain, swelling,⁵ bruising⁶ and haematoma and thrombophlebitis.⁷ However, the duration of post-procedural compression therapy is left to the clinical judgement of physicians.^3,4 Furthermore, patient compliance with compression may be poor because of discomfort, pain and skin irritation, and other complications, including allergic skin reaction, oedema and skin infection.⁸ Therefore, the role of postoperative compression is debatable. The purpose of this study was to compare the efficacy, complications and patient satisfaction after endovenous radiofrequency ablation (EVRFA) for superficial venous insufficiency between postoperative compression for 7 days and overnight compression using elastic bandage.

Methods

Study design

The Chulabhorn Research Institution’s Ethic Committee for Human Research approved this study (Ethic number 034/2564). The study was registered with Thai Clinical Trial Registry Number (TCTR) 20230914002. Written informed consent was obtained from all patients before randomization. Sixty patients who underwent EVRFA at Chulabhorn Hospital Vascular Clinic in Bangkok, Thailand, between October 2021 and October 2023 were enrolled. All patients had CEAP (Clinical-Etiology-Anatomical-Pathological) class C2–C4 superficial venous insufficiency, which was diagnosed by ultrasonography performed in the upright position with the weight supported on the contralateral leg. The patient was deemed to have superficial venous insufficiency if the Valsalva manoeuvre caused venous reflux (defined as a reflux time of >500 ms). Patients were included if they were older than 18 years, had venous reflux in the great saphenous veins and consented to EVRFA. Patients were excluded if they had a body mass index (BMI) > 40, a history of deep vein thrombosis (DVT), chronic venous ulcer or an ankle-brachial pressure index <0.9, or if they were pregnant.

Randomisation

Patients were randomly assigned in a ratio of 1:1 to wear overnight elastic bandage (the overnight compression group) or day and night for 7 days (the 7-day compression group) on the day of surgery using sealed, numbered, opaque envelopes prepared by a study nurse. The treatments were assigned using a computerised random number generator developed by a statistician who was not involved in patient care. Block randomisation was used with a block size of 6. On the day of the procedure, the r-VCSS was evaluated by the study nurse. Preoperatively, each participant was measured for a class 2 above-knee stocking, which was delivered to the treatment room. After completion of the procedure, the sealed envelope was opened to determine the intervention group.

Study endpoints

EVRFA was performed by the same surgeon in all the study participants. The primary outcome was successful obliteration of the target veins as determined by a duplex ultrasound scan at 12 weeks. The target vein was considered occluded if at least 90% of the treated length was obliterated and no more than 2 cm between the stump and junction was patent. Secondary endpoints included severity of postoperative pain (measured using a 10-point visual analogue scale [VAS] on postoperative days 1 and 14), duration of pain and major and minor post-procedural complications, including DVT, thrombophlebitis, paraesthesia, puncture site infection, haematoma and rash or blisters. Any complications were recorded during routine follow-up. The severity of disease was determined using the Revised Venous Clinical Severity Score (r-VCSS) and Aberdeen Varicose Vein Severity Score (AVSS) before surgery and 12 weeks later. All patients were followed up for 12 weeks after the procedure. Patient satisfaction was assessed using a questionnaire and scored on a 5-point scale (1, not satisfied; 2, somewhat satisfied; 3, neutral; 4, satisfied; 5, very satisfied). The outcome assessor (a vascular clinic nurse) and the statistician were blinded. Compliance with compression stockings and possible compression-related complications were recorded for patients in the 7-day compression group.

Interventions and follow-up

EVRFA is performed under local anaesthesia using a radiofrequency catheter with a Medtronic ClosureFast system (VNUS Medical Technologies, San Jose, CA, USA). The catheter is inserted into the target vein through a 7-French sheath via ultrasound-guided puncture. Before endothermal ablation, tumescent anaesthesia (450 mL of 0.9% sodium chloride solution and 20 mL of 7.5% sodium bicarbonate) is administered inside the saphenous fascial compartment under ultrasound guidance. Before ablation, the patient is placed in the Trendelenburg position. A VNUS RFGPlus radiofrequency generator is used to deliver energy to the radiofrequency probe, which is fully automated. Each effective radiofrequency ablation cycle lasts 20 s and is designed to reach a target temperature of 120°C in 5 s. Any radiofrequency ablation cycle that did not reached target temperature of 120°C in 5 s is repeated. Two cycles of treatment are administered to the most proximal segment. During a radiofrequency ablation cycle, the operator applies pressure to the treated area. Treatment for the great saphenous vein is limited to the mid-calf level to avoid saphenous neuropathy. Phlebectomy is performed if varicosity is encountered; only 1-3 incisions are for removing some varicosities. After the procedure is completed, an elastic bandage is applied to the treated limb as graduated compression bandage with dressing for 12–18 h and removed the next morning. All patients are advised to walk on a regular basis and to avoid strenuous exercise. The patient is discharged from hospital on the first postoperative day. Only paracetamol is prescribed, to be taken as needed.

Patients assigned to the 7-day compression stocking group were provided with a class 2 JOBST ® compression stocking (23–32 mmHg ankle pressure) at above knee level. The compression stocking was used for all day and night for 7 days without interruption. Each patient was provided with satisfaction questionnaires to complete at home and return them at the time of review on postoperative day 14 and at the 12-week follow-up visit. Any complications were noted during these reviews. Except when a complication such as DVT was suspected, Doppler ultrasonography was performed at 12 weeks. The r-VCSS was completed at the 12-week follow-up visit. Patients were advised to contact the clinic in between visits if necessary.

Sample size calculation

The null hypothesis in this trial was that the outcome of EVRFA with overnight post-treatment compression would be no worse than the same procedure with 7-day compression. A 98% rate of RFA-treated truncal vein occlusion was assumed in both groups. The non-inferiority margin was set at 10%, with a type 1 error of 5% and a power of 80%. Allowing for a dropout rate of 5% during follow-up, it was calculated that 30 patients were needed per group.

Statistical analysis

Continuous variables are presented as the mean ± standard deviation and categorical variables as the number (percentage). Continuous variables were compared between groups using the independent samples t-test and Mann–Whitney U test. Differences in all primary and secondary outcome variables were calculated with 95% confidence intervals (CIs). All statistical analyses were performed using STATA version 16.0 (StataCorp, College Station, TX, USA). All tests were two-sided, and a p-value of <.05 was considered statistically significant.

Results

The CONSORT flow diagram is shown in Figure 1. The mean age of the study population was 63.50 ± 13.29 years, with the overnight compression group being slightly older by a mean of 0.73 years. The sex distribution was similar between the two groups, with a tendency for more men overall. The mean BMI was 26.38 ± 5.67, although the overnight compression group was slightly more BMI than the 7-day compression group. More than half of the patients had normal weight, with the remainder being overweight (25%), obese (20%) or underweight (1.67%). With the exception of hypertension, which was more common in the overnight compression group, the distribution of comorbidities was similar between the two groups. Half of the patients in the 7-day compression group were classified as having C2 superficial venous insufficiency while more than half of those in the overnight compression group were classified as having C4, indicating that superficial venous insufficiency was worse in the overnight compression group. The mean r-VCSS was lower in the 7-day compression group than in the overnight compression group (5.57 ± 3.05 vs 8.07 ± 4.79), as was the mean AVSS (7.44 ± 3.68 vs 9.50 ± 4.77). The target vessel was the great saphenous vein in all cases and the small saphenous vein in two cases in each group. The diameter of the target vein was smaller in the 7-day compression group than in the overnight compression group (7.54 ± 2.19 mm vs 8.11 ± 2.39 mm. The procedure was performed in both limbs in more than half of the patients in each group. There was no significant between-group difference in operation time, treatment length, cycles of radiofrequency ablation, energy of radiofrequency ablation or volume of tumescent anaesthesia administered (Table 1). All patients attended both follow-up visits. At 12 weeks, target vein occlusion was confirmed in all patients in both groups. The compliance rate was 100% in the 7-day compression group.

Figure 1.

The CONSORT flow diagram.

Table 1.

Background characteristics of the study population.

Variable	Overall (n = 60)	7-day compression group (n = 30)	Overnight compression group (n = 30)	Difference (95% CI)
Age (years)	63.50 ± 13.29	58.63 ± 13.24	59.37 ± 11.63	0.73 (0.29–3.17)
Female	25 (41.67)	13 (43.33)	12 (40.00)
Male	35 (58.33)	17 (56.67)	18 (60.00)
BMI	26.38 ± 5.67	25.42 ± 4.25	27.35 ± 6.74	1.93 (−0.98, 4.84)
Normal weight (BMI 18.5–24.9)	32 (53.33)	19 (63.33)	13 (43.33)
Overweight (BMI 25–29.9)	15 (25.00)	6 (20.00)	9 (30.00)
Obesity (BMI > 30)	12 (20.00)	5 (16.67)	7 (23.33)
Diabetes mellitus	12 (20.00)	4 (13.33)	8 (26.67)
Hypertension	29 (48.33)	9 (30.00)	20 (66.67)
Dyslipidaemia, n (%)	20 (33.33)	10 (33.33)	10 (33.33)
CEAP classification
C2	23 (38.33)	15 (50.00)	8 (26.67)
C3	8 (13.33)	5 (16.67)	3 (10.00)
C4 (a + b + c)	29 (48.33)	10 (33.33)	19 (63.33)
Clinical score
Preoperative r-VCSS	6.82 ± 4.18	5.57 ± 3.05	8.07 ± 4.79	2.5 (0.42–4.58)
Preoperative AVCSS	8.49 ± 4.36	7.44 ± 3.68	9.50 ± 4.77	2.06 (−0.26, 4.37)
Involved vein
GSV	60 (100.00)	30 (100.00)	30 (100.00)
SSV	2 (3.33)	1 (3.33)	1 (3.33)
Involved limb
Left	8 (13.33)	4 (13.33)	4 (13.33)
Right	13 (21.67)	8 (26.67)	5 (16.67)
Both	39 (65.00)	18 (60.00)	21 (70.00)
Surgical details
Diameter of treated vein (mm)	7.83 ± 2.30	7.54 ± 2.19	8.11 ± 2.39	0.57 (−0.35–1.48)
Operation time (min)	42.77 ± 17.47	43.73 ± 18.07	41.80 ± 17.11	1.93 (−11.03–7.16)
Additional phlebectomy	26 (43.33)	13 (43.33)	13 (43.33)

Data are presented as the mean ± standard deviation or as the number (percentage).

AVSS: Aberdeen Varicose Vein Severity Score; BMI: body mass index; CEAP: clinical-etiology-anatomical-pathological class; GSV: great saphenous vein; Preop: preoperative; RF: radiofrequency; r-VCSS: Revised Venous Clinical Severity Score; SSV: small saphenous vein.

The occlusion rate was 100% in both groups. There was no difference in patient satisfaction or pain scores at day 1, day 10 or 12 weeks between the 7-day compression and overnight compression groups. After 2 weeks, one case of ecchymosis was found in the 7-day compression group and one of phlebitis in the overnight compression group. The ecchymosis resolved within 1 month after surgery. The phlebitis was treated with warm compression and non-steroidal anti-inflammatory drugs and improved 1 week later. Neither of them performed a phlectomy, even though the patient had phlebitis and ecchymosis. There were no cases of endothermal heat-induced thrombosis or wound complications. Table 2 shows that most patients in both groups were satisfied or very satisfied with their treatment.

Table 2.

Primary and secondary outcomes.

Outcome	Overall (n = 60)	7-day compression group (n = 30)	Overnight compression group (n = 30)	Mean ratio (95% CI)	p-value
Primary outcome
Target vein occlusion at 12 weeks	60 (100.00)	30 (100.00)	30 (100.00)		1.000
Secondary outcomes
VAS score on postoperative day 1	1.93 ± 1.12	1.83 ± 0.99	2.03 ± 1.25	0.20 (−0.38, 0.78)	.493
VAS on postoperative day 10	1.93 ± 1.12	0.23 ± 0.57	0.27 ± 0.78	1.14 (0.28–4.62)	.851
VAS at 12–16 weeks	0.25 ± 0.68	0.10 ± 0.40	0.07 ± 0.37	0.67 (0.06–7.95)	.749
Duration of pain (days)	2.53 ± 3.26	2.87 ± 3.89	2.20 ± 2.51	0.77 (0.39– 1.50)	.440
Ecchymosis	1 (1.67)	0 (0.00)	1 (3.33)		1.000
Phlebitis	1 (1.67)	1 (3.33)	0 (0.00)		1.000
Satisfaction score	4.38 ± 0.78	4.20 ± 0.85	4.57 ± 0.68	0.37 (−0.03, 0.76)	.065
Satisfaction					.081
Not satisfied	0 (0.00)	0 (0.00)	0 (0.00)
Somewhat satisfied	2 (3.33)	1 (3.33)	1 (3.33)
Neutral	5 (8.33)	5 (16.67)	0 (0.00)
Satisfied	21 (35.00)	11 (36.67)	10 (33.33)
Very satisfied	32 (53.33)	13 (43.33)	19 (63.33)

Data are presented as the mean ± standard deviation or as the number (percentage). The p-value indicates the difference between the experimental and control arms (the independent samples t-test and Mann–Whitney U test were used to compare continuous variables between groups). A p-value of .05 was considered statistically significant.

POD: postoperative day; VAS: visual analogue scale.

Age, sex, comorbidities, vein diameter, baseline varicose vein status, duration of compression treatment and preoperative AVSS and r-VCSS values did not predict treatment success or failure. The procedure (operation time, tumescent volume, treatment and postoperative pain) had no effect on the primary outcome. Table 3 shows the improvement in r-VCSS and AVSS values at 12 weeks postoperatively. Although these findings indicated significant improvement in the r-VCSS in the overnight compression group, this could be attributed to a higher preoperative r-VCSS. However, there was no between-group difference in postoperative VCSS or in the preoperative and postoperative AVSS at 12 weeks.

Table 3.

Comparison of clinical efficacy between the study groups.

	Overall (n = 60)	7-day compression group (n = 30)	Overnight compression group (n = 30)	Difference (95%CI)	p-value
Preop r-VCSS	6.82 ± 4.18	5.57 ± 3.05	8.07 ± 4.79	2.50 (0.42–4.58)	.037
Postop r-VCSS at 12 weeks	3.03 ± 3.20	2.50 ± 2.27	3.57 ± 3.88	1.07 (−0.58, 2.71)	.388
Improvement in r-VCSS	3.78 ± 2.37	3.07 ± 1.51	4.50 ± 2.85	1.43 (−2.61, 3.17)	.038
Preop AVCSS	8.49 ± 4.36	7.44 ± 3.68	9.50 ± 4.77	2.06 (−0.26, 4.37)	.094
Postop AVCSS at 12 weeks	2.85 ± 2.41	2.56 ± 2.53	3.14 ± 2.30	0.59 (−0.72, 1.90)	.171

AVSS: Aberdeen Varicose Vein Severity Score; CI: confidence interval; Preop: preoperative; r-VCSS: revised Venous Clinical Severity Score.

Discussion

Even though numerous meta-analyses had been conducted to determine the precise amount of time required for postoperative compression following endovenous thermal ablation, the ideal length remained an issue of dispute. We discovered that there were differences in patient severity, endothermal technique (EVRFA only or both EVRFA and EVLA), compression protocol, timing and the use of foam sclerotherapy or phlebectomy that could have an impact on several issues, such as venous ulcer pain, phlebectomy pain, multiple techniques or numerous surgeons. Therefore, we eliminated patients with ulcers that could affect their pain in order to construct this trial. We only utilized one surgeon and the EVRFA technique. We used adjunct phlebectomy to see whether the overnight compression bandage could minimize discomfort, so we started with the compression bandage and switched to stockings after 7 days, while another group did not wear the stockings. Compared to the prior advice for 7 days, our study may assist in determining whether to utilize compression for pain management based on favorable efficacy from EVRFA with or without phlebectomy.

This study found that postoperative overnight compression after truncal EVRFA had no effect on the target vein occlusion rate and achieve to 100% target vein occlusion, which was comparable to the 7-day compression therapy. Moreover, there was no significant difference in the pain score, complication rate, postoperative r-VCSS and AVSS values, or patient satisfaction with 100% target vein occlusion in both groups according to the duration of postoperative compression. There was also no significant difference in the pain score or complication rate according to whether additional phlebectomy was performed. EVRFA has been shown to be effective for truncal vein occlusion in previous studies,^6,9 and the benefit of this treatment for chronic venous disease is now established.¹⁰ Endovenous thermal ablation causes venous occlusion by promoting intimal thermal injury, thrombosis and fibrosis.¹¹ The goal of postoperative compression is to achieve luminal compression of the treated vein while avoiding or minimising inflammation, pain, bruising, bleeding and haematoma,⁴ which may be helpful in the initial stage after EVRFA.

The findings of RCTs comparing compression with no compression after endovenous thermal ablation have been inconsistent.⁴ However, analysing and comparing trials is difficult because of heterogeneity in the modality and degree of compression used, variation in duration of compression and incomplete reporting of compliance.⁴ In the past few years, several systematic reviews and meta-analyses have assessed the benefit and optimal duration of compression therapy after endovenous thermal ablation. One concluded that compression stockings provided no benefit other than mild pain relief and that postoperative compression may be unnecessary.¹² That study examined seven RCTs involving 1146 patients and found that wearing compression stockings had no impact on quality of life, the major complication rate, the target vein occlusion rate or time to return to work; however, it did find a significantly reduced postoperative pain score. Although that study found that post-procedural compression therapy only reduced postoperative pain, other recent RCTs found no difference in postoperative pain.^13,14

Numerous RCTs have demonstrated that no compression is non-inferior to compression therapy and has fewer complications. Onwudike et al.¹³ found no significant difference in AVSS and r-VCSS values, patient satisfaction or pain scores at 12 weeks after target vein occlusion in 100 patients with C2–C6 superficial venous insufficiency according to whether or not compression stockings were worn for 2 weeks after the procedure. Pihlaja et al. compared post-procedural compression (with stockings worn continuously for 2 days and then only during the day for 5 days) with no compression after radiofrequency ablation and concomitant foam sclerotherapy in 177 patients with C2–C4 superficial venous insufficiency.¹⁴ They found no significant between-group difference in the 6-month target vein occlusion rate, 6-month AVSS value, frequency of full physical activity at postoperative day 14, or pain scores. However, skin rash and blisters were significantly more common in the compression group. Furthermore, Ayo et al found no significant difference in the post-procedural pain score on days 1 and 7, the CIVIQ-2 score at 1 week and 90 days, or the bruise score between their compression group and their no compression group, with a 100% great saphenous vein closure rate in both groups and no endothermal heat-induced thrombosis.¹⁵ Similarly, we found no significant difference in the 12-week target vein occlusion rate with 100% of target vein occlusion in both groups, AVSS and postoperative r-VCSS values, patient satisfaction, or pain score between the two groups in our study, despite our overnight compression group being older and having higher BMI, a higher CEAP classification, a higher preoperative r-VCSS, and more comorbidities. Furthermore, the improvement in r-VCSS was significantly greater in our overnight compression group, possibly because of a higher preoperative r-VCSS. Although one patient in the overnight compression group had a pain score of 5 on postoperative day 1, there was no statistically significant between-group difference in pain scores. Of note in this regard is that we enrolled 60 patients with C2–C4 superficial venous insufficiency and excluded those with C5–C6, who require continuous compression therapy for wound healing and experience chronic wound pain. Furthermore, the benefit of compression after high ligation and venous stripping has been questioned, with data showing that wearing or not wearing stockings for 4 weeks following inversion stripping of the great saphenous vein has no effect on leg oedema, complications or the pain score.¹⁶

However, many guidelines and RCTs recommend wearing of compression stockings after superficial vein surgery. The 2022 European Society of Vascular Surgery guideline recommends consideration of post-procedural compression treatment in patients undergoing endovenous thermal ablation and immediate compression after extensive phlebectomy.⁴ The duration of post-procedural compression is still debatable and is determined by the treating physician. A meta-analysis of five RCTs (775 patients) that examined compression ranging from 24 h to 2 weeks recommended compression for at least 1 week following endovenous thermal ablation.¹⁷ This recommendation supported the findings of a previous meta-analysis, which found that compression for 3–10 days provided the same benefit as compression for longer periods.¹⁸ Furthermore, a recent systematic review of 18 studies (2584 treated limbs) found that the mean pain score was lower with compression for 1–2 weeks than with compression for a shorter duration and improved quality of life and patient satisfaction.¹⁹ Furthermore, the authors found that a longer duration of compression provided no additional benefit. As mentioned earlier, the evidence indicates that 1 week of post-procedural compression reduces pain, but some studies have only found a benefit of pain reduction with a shorter duration of compression therapy. The COMETA study, which was an RCT, compared 7 days of compression with no compression in 206 patients and found that the median pain score was significantly better in the group that wore compression stockings on days 2–5 and that patients who underwent concurrent phlebectomy and wore compression stockings had significantly better pain scores on days 1–3, 5 and 7.²⁰ The between-group difference in improvement in VCSS, disease-specific quality of life and time to return to activity after 6 months was not statistically significant. Therefore, they concluded that wearing compression stockings after endovenous thermal ablation is beneficial in the first few days, especially for patients who have undergone concurrent phlebectomy. Mii et al. found no difference in pain scores, quality of life, VCSS or leg circumference according to whether compression stockings were worn for a short duration (0–2 days) or long duration (1–4 weeks).²¹ Similarly, we found no difference in pain score, rate of improvement in the r-VCSS or AVSS, or the number of complications between our 7-day compression group and our overnight compression group (12–18 h). One study compared 4 h and 72 h of leg compression and reported that the shorter duration resulted in a greater reduction in leg volume and fewer complications but with no significant difference in postoperative pain or time to full recovery.²² Therefore, the optimal duration of post-procedural compression may be less than 1 week. In contrast, a recent study found that compression stockings worn for 7 days reduced pain and swelling more than compression stockings worn for 24 h.²³ However, the 2022 European Society of Vascular Surgery guideline concludes that the duration of post-intervention compression used to minimise postoperative local complications should be decided by the attending physician, leaving the optimal duration as a contentious issue.⁴ Furthermore, the American Venous Forum advises application of a pressure greater than 20 mmHg after surgery for a duration based on clinical judgement.³

Use of compression stockings may result in some adverse events, the most common of which are skin irritation, discomfort and pain.⁸ Compression may also cause severe complications, including soft tissue damage or necrosis, nerve damage, arterial impairment, venous thromboembolism and cardiac decompensation, all of which are extremely rare.⁸ Other minor complications include allergic skin reactions, forefoot oedema, lymphedema and bacterial or fungal infection.⁸ Therefore, the care of patients who receive compression therapy should be carefully considered and individually tailored. Clinicians should also be aware of the contraindications to compression stockings, particularly peripheral arterial disease with an ankle pressure of less than 60 mmHg.⁸ In view of the potential complications of compression therapy, the duration of post-procedural compression should be determined by the clinician based on optimal efficacy and minimising the risk of complications. Even though there is strong evidence to support 1 week of post-procedural compression to reduce pain, a shorter duration may be considered in view of the increasing body of evidence supporting its non-inferiority to a longer duration. Our study excluded patients with C5–C6 chronic venous ulcers, which require continuous compression therapy for wound healing and interfere with chronic wound pain. The American Venous Forum recommends compression after superficial vein treatment for a venous leg ulcer rather than no compression to improve healing and reduce the risk of ulcer recurrence.³ Concurrent phlebectomy was performed with equal frequency in both our study groups, and the primary and secondary outcomes did not differ significantly between the two groups. Therefore, patients who undergo EVRFA may only require overnight compression therapy following the procedure regardless of whether concurrent phlebectomy is performed.

This study has some strengths. Blinding of the outcomes assessor and statistician and randomisation meant that the risk of selection bias was low. Furthermore, all patients completed the study, which reduced the risk of type 2 error. Nevertheless, the study lacked the power to detect between-group differences in complications because of their very low incidence. All the procedures were performed by the same surgeon, so there was no difference in technique. Moreover, there was no between-group difference in the proportion of patients who underwent concurrent phlebectomy. The study also has several limitations, including its single-centre design, a relatively short follow-up duration and use of a 10-point VAS rather than the standard 100-mm VAS for measuring pain. Furthermore, there were differences in several background characteristics between the study groups, including age, BMI, disease severity and preoperative r-VCSS.

Based on these findings, overnight post-procedural compression after EVRFA with or without concurrent phlebectomy for C2–C4 venous disease appears to be non-inferior to post-procedural compression for 7 days in terms of safety and efficacy. However, a larger multicentre trial may be required to confirm our findings.

Conclusion

In terms of safety and efficacy, overnight post-procedural compression was non-inferior to post-procedural compression for 7 days after treatment of C2–C4 superficial venous insufficiency with EVRFA with or without concurrent phlebectomy.

Footnotes

Acknowledgements

The authors extend their thanks to all the study participants and the staff of Chulabhorn Hospital for their kind assistance and support with this study. They are also grateful to Edanz () for editing a draft of the manuscript.

Author contributions

All authors contributed to the literature review and study design. TN performed the statistical analysis. TN, BM and KM contributed to data collection and entry. All authors contributed to writing the manuscript. All authors read and approved the final manuscript. Each author has participated sufficiently in the work to take public responsibility for the content.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was supported by a Chulabhorn Hospital Research Grant.

Guarantor

TN.

Ethical statement

ORCID iD

Nawaphan Taengsakul

References

Vuylsteke

Thomis

Guillaume

, et al. Epidemiological study on chronic venous disease in Belgium and Luxembourg: prevalence, risk factors, and symptomatology. Eur J Vasc Endovasc Surg 2015; 49: 432–439.

National Institute for Health and Care Excellence . Varicose veins in the legs: the diagnosis and management of varicose veins. London, UK: National Institute for Health and Care Excellence, 2013. Available from: https://www.nice.org.uk/guidance/cg168/chapter/1-recommendations Accessed January 15, 2024.

Lurie

Lal

Antignani

, et al. Compression therapy after invasive treatment of superficial veins of the lower extremities: clinical practice guidelines of the American venous Forum, society for vascular surgery, American College of phlebology, society for vascular medicine, and international union of phlebology. J Vasc Surg Venous Lymphat Disord 2019; 7: 17–28.

De Maeseneer

Kakkos

Aherne

, et al. Editor’s choice – European society for vascular surgery (ESVS) 2022 clinical practice guidelines on the management of chronic venous disease of the lower limbs. Eur J Vasc Endovasc Surg 2022; 63: 184–267.

Trevor

Rhodes

Hardy

, et al. Postoperative limb compression in reduction of haemorrhage after varicose vein surgery. Ann R Coll Surg Engl 1993; 75: 119–122.

Rasmussen

Bjoern

Lawaetz

, et al. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J Vasc Surg 2007; 46: 308–315.

Shouler

Runchman

. Varicose veins: optimum compression after surgery and sclerotherapy. Ann R Coll Surg Engl 1989; 71: 402–404.

Rabe

Partsch

Morrison

, et al. Risks and contraindications of medical compression treatment – a critical reappraisal. An international consensus statement. Phlebology 2020; 35: 447–460.

Rasmussen

Lawaetz

Bjoern

, et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg 2011; 98: 1079–1087.

10.

Rautio

Ohinmaa

Perälä

, et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs. J Vasc Surg 2002; 35: 958–965.

11.

Passariello

Goldman

Mordon

, et al. The mechanism of action of LASER and radiofrequency in great saphenous vein thermal ablation. Acta Phlebol 2010; 11: 35–39.

12.

Wang

, et al. No benefit of wearing compression stockings after endovenous thermal ablation of varicose veins: a systematic review and meta-analysis. Eur J Vasc Endovasc Surg 2022; 63: 103–111.

13.

Onwudike

Abbas

Thompson

, et al. Role of compression after radiofrequency ablation of varicose veins: a randomised controlled trial. Eur J Vasc Endovasc Surg 2020; 72: 751.

14.

Pihlaja

Romsi

Ohtonen

, et al. Post-procedural compression vs. no compression after radiofrequency ablation and concomitant foam sclerotherapy of varicose veins: a randomised controlled non-inferiority trial. Eur J Vasc Endovasc Surg 2020; 59: 73–80.

15.

Ayo

Blumberg

Rockman

, et al. Compression versus no compression after endovenous ablation of the great saphenous vein: a randomized controlled trial. Ann Vasc Surg 2017; 38: 72–77.

16.

Houtermans-Auckel

van Rossum

Teijink

, et al. To wear or not to wear compression stockings after varicose vein stripping: a randomised controlled trial. Eur J Vasc Endovasc Surg 2009; 38: 387–391.

17.

Chou

Chen

, et al. Optimal duration of compression stocking therapy following endovenous thermal ablation for great saphenous vein insufficiency: a meta-analysis. Int J Surg 2019; 65: 113–119.

18.

Huang

Chen

Bai

, et al. The optimal duration of compression therapy following varicose vein surgery: a meta-analysis of randomized controlled trials. Eur J Vasc Endovasc Surg 2013; 45: 397–402.

19.

Mohamed

Thadani

Mohamed

, et al. Compression following treatment of superficial venous incompetence: systematic review. Br J Surg 2022; 109: 679–685.

20.

Bootun

Belramman

Bolton-Saghdaoui

, et al. Randomized controlled trial of compression after endovenous thermal ablation of varicose veins (COMETA trial). Ann Surg 2021; 273: 232–239.

21.

Mii

Guntani

Yoshiga

, et al. Optimal duration of compression stocking therapy after endovenous laser ablation using a 1470-nm diode dual-ring radial laser fiber for great saphenous vein insufficiency. Ann Vasc Dis 2021; 14: 122–131.

22.

Krasznai

Sigterman

Troquay

, et al. A randomised controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence. Phlebology 2016; 31: 118–124.

23.

Coelho

Araújo

WJB

Belczak

, et al. Influence of compression therapy following varicose vein surgery: a prospective randomized study. J Vasc Bras 2023; 22: e20220052.