Clinical trial of concomitant vs staged foam sclerotherapy of varicose veins following axial thermal ablation

Maciej Wołkowski; Tomasz Urbanek; Krzysztof Wołkowski; Grzegorz Biolik; Wacław Kuczmik

doi:10.1016/j.jvsv.2026.102518

. 2026 May 15;14(5):102518. doi: 10.1016/j.jvsv.2026.102518

Clinical trial of concomitant vs staged foam sclerotherapy of varicose veins following axial thermal ablation

Maciej Wołkowski ^a,^∗, Tomasz Urbanek ^a, Krzysztof Wołkowski ^b, Grzegorz Biolik ^a, Wacław Kuczmik ^a

PMCID: PMC13264176 PMID: 42140584

Abstract

Objectives

Endovenous laser ablation (EVLA) of the great saphenous vein may be combined with tributary vein treatment, either during the same session or in a staged manner with deferred foam sclerotherapy (FS) or miniphlebectomy. Despite recent multisociety guidelines favoring a concomitant approach, evidence supporting this recommendation remains limited, and the patient profiles best suited for each strategy are not well defined. This study aimed to compare clinical outcomes, quality of life, and patient-reported results after EVLA with simultaneous vs delayed FS, and to assess whether one strategy offers a clear advantage.

Methods

The study included 152 patients with Clinical Etiological Anatomical Pathophysiological classification C2 to C4 chronic venous disease, allocated to two groups. The concomitant group (CG; n =75) underwent EVLA with simultaneous FS of the tributary veins, and the staged group (SG; n = 77) received FS 3 months after EVLA only if necessary due to inadequate tributary vein regression. Treatment allocation followed a shared decision-making process after detailed patient counseling. Follow-up assessments were conducted at 7 days and 1, 3, and 6 months post EVLA, with analysis of tributary vein regression and procedural characteristics.

Results

Complete anatomical success of great saphenous vein ablation was achieved in all patients. After 6 months, the CG demonstrated greater improvement on the Chronic Venous Insufficiency Questionnaire. The revised Venous Clinical Severity score and Aberdeen Varicose Veins Questionnaire scores were comparable at 6 months of follow-up. At 3 months, the CG showed fewer and shorter incompetent tributary veins, although this difference was no longer observed at 6 months. Patient satisfaction was comparable between the groups. In the SG, 36 patients (46%) required no additional FS. When FS was necessary in patients in the SG, lower sclerosant volumes and concentrations were used, treated tributary segments were shorter, and the incidence of hyperpigmentation was significantly reduced.

Conclusions

Deferring tributary vein treatment after EVLA limits the extent of intervention, reduces sclerosant use, and lowers the risk of hyperpigmentation. Both simultaneous and delayed treatment approaches result in favorable final outcomes and are associated with comparable levels of patient satisfaction. Simultaneous EVLA with FS may be offered to patients seeking rapid clinical improvement, whereas a delayed strategy is justified in those accepting longer treatment times to decrease sclerotherapy-related complications.

Keywords: Endovenous, Sclerotherapy, Concomitant, Staged, Varicose veins

Article Highlights.

•
Type of Research: Single-center prospective nonrandomized study
•
Key Findings: Patients treated concomitantly (endovenous laser ablation [EVLA] of insufficient great saphenous vein + foam sclerotherapy [FS] of the tributaries) experience faster regression of tributaries (64 [85%] vs 39 [50.6%] after 3 months. Due to complete tributary regression, 36 patients (46%) choosing deferred FS (3 months after EVLA) did not require it at all.
•
Take Home Message: In patients who require immediate effect after EVLA for great saphenous vein insufficiency, concomitant FS should be considered, whereas deferring FS may be justified in patients willing to accept a longer treatment to reduce sclerotherapy-related local consequences.

Chronic venous disease (CVD) is a progressive condition that affects a significant proportion of the population and encompasses a spectrum of clinical manifestations.¹ The presence of symptomatic reflux in the saphenous trunk together with varicose veins (VV) related to its tributary incompetence remains one of the most common indications for invasive treatment. According to current guidelines, the first-line therapy in such clinical scenarios remains ablation of the incompetent saphenous vein, whereas tributary removal can be based on miniphlebectomy or foam sclerotherapy (FS). Both these methods of tributary treatment can be used as a part of a truncal ablation procedure (simultaneously) or as a staged procedure.² According to the recent American Venous Forum/Society for Vascular Surgery guidelines, in patients undergoing saphenous ablation, concomitant tributary treatment is suggested.³^,⁴ Following the recommendations from 2022 European Society for Vascular Surgery guidelines, concomitant tributary treatment should be considered as a part of a shared decision-making process.⁵ Among the main arguments to support concomitant tributary removal, the following should be mentioned: immediate effect, better patient satisfaction, faster improvement in quality of life (QOL), and lower reintervention rates.²^,³^,5, 6, 7 In both sets of guidelines, the preferred method of tributary treatment is not specified; however, references for these recommendations are based mostly on the miniphlebectomy studies.⁶^,8, 9, 10, 11, 12 The data concerning FS implementation in the tributary treatment confirm the efficacy of FS in concomitant or staged treatment in patients undergoing saphenous ablation.⁵^,13, 14, 15, 16, 17 However, to date, there has been no prospective comparison study available concerning immediate or delayed FS after truncal ablation in terms of clinical efficacy and possible adverse events. There have also been no head-to-head randomized comparisons between miniphlebectomy and sclerotherapy used concomitantly or as a deferred approach in the treatment of tributary incompetence. This prospective nonrandomized clinical study was designed to compare the results and benefits of thermal ablation of the great saphenous vein (GSV) followed by concomitant or deferred FS of the tributaries.

Methods

Treatment decisions and group allocation were based on a shared decision-making process; patients were provided with detailed information regarding the two procedures.⁵ This study was approved by the Bioethical Committee of the Medical University of Silesia (PCN/0022/KB1/56/21). All patients provided informed consent for the proposed treatments. Symptomatic CVD patients in classes C2 to C4 were recruited. Study exclusion criteria were a history or the presence of deep or superficial vein thrombosis, prior surgical treatment of lower limb VVs, contraindications to sclerotherapy, the presence of other truncal vein incompetence, the use of venoactive drugs, and contraindications to compression therapy. The study was performed between June 2021 and June 2024.

The median patient age was 51.5 years (range, 18-86 years) and 152 individuals (97 women and 55 men) with GSV truncal incompetence and VVs related to GSV tributary incompetence were recruited into the study. Baseline patient characteristics are presented in Table I. We included 75 patients in the concomitant treatment group (CG) (thermal ablation of the GSV + intraoperative FS) and 77 patients in the staged group (SG) (thermal ablation of the GSV + delayed FS).

Table I.

Baseline characteristics of concomitant and staged group (SG) of treatment

Parameter	CG	SG	P value
Median age, years	53 (41-64)	51 (41-60)	.193^a
Sex			χ² = 1.05, P = .219
Female	45	52
Male	32	23
BMI	25.33 ± 2.45	25.42 ± 2.78	.168^b
GSV diameter, mm
At 3 cm below the SFJ	12 (10.0-14.6)	11 (10-14)	.155^a
Mid-thigh	8 (6.5-9)	8 (6-8)	.195^a
Medial ankle	3 (3.00-3.75)	3 (3.0-3.4)	.471^a
Patients with incompetent perforators	14 (19)	15 (20)	.665^a
Length of GSV treated, cm	47 ± 10	46 ± 9	.59^b
Level of the GSV trunk incompetence			χ² = 0.425, P = .808
Thigh length (from the SFJ to the distal thigh - Hach classification type II)	4 (5)	4 (5)
Thigh length + upper crural segment - Hach classification type III	38 (51)	43 (56)
Thigh and below the knee GSV segment -Hach classification type IV	33 (44)	30 (39)
Mean length of incompetent tributaries, cm	42.1 ± 15.31	41.92 ± 14.94	.94^b
Median diameter of incompetent tributaries, mm	4 (2-6)	4 (2-6)	>.91^a
CEAP classification			.14^c
C2	22 (29)	20 (26)
C3	41 (55)	37 (48)
C4	12 (16)	20 (26)
Preoperative rVCSS	6 (5-8)	6 (5-8)	.438^c
Preoperative AVVQ	22 (14.45-27.00)	18 (12.28-27.11)	.102^c
Preoperative CIVIQ20	45 (38.5-57.0)	44 (37-55)	.268^c

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AVVQ, Aberdeen Varciose Veins Questionnaire; BMI, body mass index; CEAP, Clinical Etiological Anatomical Pathophysiological; CG, concomitant treatment group; CIVIQ-20, Chronic Venous Insufficiency Questionnaire; GSV, great saphenous vein; rVCSS, revised Venous Clinical Severity Score; SFJ, saphenofemoral junction; SG, staged treatment group.

Values are median (range), mean ± standard deviation, or number (%).

Mann-Whitney U test.

t-test.

Mann-Whitney U and trinominal tests.

All patients underwent endovenous laser ablation (EVLA) of the GSV under tumescent anesthesia using a Lasotronix (Piaseczno, Poland) Smart M laser with a 1470-nm wavelength with radial fibers. In patients with ankle-level GSV incompetence, the vein was punctured above the mid-calf level to avoid saphenous nerve injury. In all other patients, vein lumen access was obtained at the lowest level of GSV incompetence. In the CG, FS was performed during the same session, immediately after GSV ablation. In the SG, FS was performed 3 months after thermal ablation. In all patients treated by FS, the amount of the foam as well as the drug concentration were noted. Preoperative photographic documentation of the treated extremity was done. The number, length, and size (diameter) of the tributaries were measured by a combination of visual assessment (number) and ultrasound examination (number, length, and size) both before and after treatment. Follow-up visits were conducted at 7 days, 1 month, 3 months, and 6 months post procedure. During each follow-up visit, physical and duplex ultrasound examinations were performed and photographic documentation was taken. At the follow-up visit in the SG, patients were assessed in regard to adjunctive FS. If the tributaries of the GSV that were marked during the first visit were still patent, the patient qualified for FS. Additionally, assessment of disease severity as well as QOL were performed using the revised Venous Clinical Severity Score (rVCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Chronic Venous Insufficiency Questionnaire (CIVIQ-20). Patient satisfaction with their treatment was assessed, and treatment-related complications were noted. The study’s clinical efficacy end point was VV regression observed at 3 and 6 months after the primary procedures (defined as complete visual disappearance of treated VVs or confirmed lack of patency on ultrasound examination). The clinical safety end point was the occurrence of serious adverse events (deep vein thrombosis, pulmonary embolism, anaphylactic shock, skin necrosis, or vision disorders) in the follow-up period (≤6 months). After EVLA, all patients received class II thigh-length compression stockings to wear for 7 days. In patients in the SG group, the thigh-length class II compression stockings worn for 7 days were also used after FS performed 3 months after the initial treatment. Further continuation of compression was considered for patients who remained symptomatic despite treatment, based on examinations during the follow-up period.

Statistical analyses

Descriptive statistics for quantitative variables included the mean, standard deviation, minimum, maximum, quartile 1, median, and quartile 3. Depending on the distribution, parametric or nonparametric tests were applied. Comparisons between two independent groups used the Student t-test or Mann-Whitney U test, and paired data were analyzed with the paired t-test or Wilcoxon signed-rank test; for ordinal paired data, the sign test was used. For nonparametric analyses, Shapiro-Wilk results and means with standard deviations were reported; nominal data were analyzed with the χ² test or Fisher's exact test where appropriate. A two-sided significance level (α) of 0.05 was used for all statistical analyses.

Results

Anatomical success, defined as GSV occlusion, confirmed at the 6-month follow-up visit, was achieved in all patients (100%). Complete VV regression, either clinically or confirmed by ultrasound examination at 6 months, was observed in 71 patients (95%) in the CG and 73 patients (95%) in the SG (P = .74).

In the SG, occlusion of the GSV was associated with a favorable effect on VV regression. However, a significantly higher rate of complete regression, eliminating the need for further sclerotherapy at 3 months, was observed in the CG (Table II). Notably, in the SG, 36 patients (46%) showed complete regression of VV 3 months after EVLA, and thus did not require adjunctive sclerotherapy. Although statistical analysis demonstrated a significant advantage of simultaneous treatment in terms of VV regression at 3 months, this difference was not observed at the 6-month follow-up (Table II).

Table II.

Impact of treatment modality on varicose vein (VV) regression 3 and 6 months after endovenous laser ablation (EVLA)

Feature	CG	SG	P value	χ²
VV regression (after 3 months)	67 (85)	39 (51)	.001	25.14
VV regression (after 6 months)	71 (95)	73 (95)	.745 (Fisher's exact test: P = .626)	0.106

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CG, Concomitant treatment group; SG, staged treatment group.

Values are number (%).

When comparing rVCSS scores between groups defined by treatment modality, no significant differences were observed at the baseline assessment. By the 6-month follow-up, after completion of treatment, no statistically significant differences in the rVCSS were observed between the groups (Fig 1).

Fig 1 — Assessment of the clinical severity of venous disease (Revised Venous Clinical Severity Score [*rVCSS*]) in operated patients, with respect to the type of treatment (results of the Mann-Whitney test and the trinomial test). *Max*, Maximum; Me, median; *Min*, minimum.

QOL related to the performed treatment was assessed using the AVVQ and CIVIQ-20. At baseline, no significant differences were observed between the treatment groups for either the AVVQ or the CIVIQ-20. After 6 months, both groups showed a comparable degree of improvement assessed with the AVVQ (Fig 2). On the CIVIQ-20, there were comparable baseline assessment results in both groups; however, a significant difference emerged at the 6-month follow-up in favor of the CG (23.0 ± 2.4 vs 24.0 ± 3.5). Both groups demonstrated a statistically significant improvement in QOL; however, the improvement was significantly greater in the CG.

Fig 2 — Quality of life (QOL) in patients with lower-limb varicose veins (VVs) Aberdeen Varicose Veins Questionnaire ([*AVVQ*]) who underwent the treatment, with respect to the type of treatment (results of the Mann-Whitney test and the trinomial test). *Max*, Maximum; Me, median; *Min*, minimum.

In both groups, the level of patients satisfaction was evaluated using a visual analog scale.¹⁸ In both the SG and CG, satisfaction levels were high and comparable (Fig 3).

Fig 3 — Assessment of patient satisfaction after surgery with respect to the type of treatment (result of the Mann-Whitney test). *Max*, Maximum; Me, median; *Min*, minimum; *VAS*, visual analog scale.

Before treatment, 30.3% of patients wore compression garments, 22 (29.3%) in the CG and 24 (31.2%) in the SG. The use of the medical compression stockings beyond the perioperative period (7 days after the procedure as scheduled in the method) was reported in 19 patients (26%) in the CG and 22 (29%) in the SG, with no statistically significant difference between the groups.

Sclerotherapy treatment data

In the SG, FS of incompetent tributaries was required in only 39 patients (54%) who underwent GSV ablation. At baseline, there were no statistically significant differences between the groups in the number, length, or diameter of incompetent GSV tributaries supplying the varicosities. However, comparing both groups on the day of sclerotherapy (during saphenous ablation in the CG vs at 3 months after the saphenous ablation in the SG), the CG had a significantly greater number of tributaries requiring intervention. Additionally, both the diameter and length of the treated tributaries were significantly smaller in the SG after EVLA compared with the values observed before treatment (which were initially comparable with the CG group). FS was performed using a polidocanol mixture (Aethoxysklerol) according to the Tessari method.¹⁹ Sclerosant concentration was selected basing on the European Guidelines on Sclerotherapy,⁵ and all procedures were carried out by the same physician. Significantly greater sclerosing agent concentrations as well as foam volumes were used in the CG compared with the SG at the time of sclerotherapy (Table III).

Table III.

Comparison of key sclerotherapy parameters between simultaneous and deferred treatment on the day of sclerotherapy performance

Parameter	CG	SG	P value
Patients requiring sclerotherapy	75 (100)	41 (54)	—
No. of tributaries requiring treatment	2 (1-3)	2 (1-3)	<.05^a
Mean tributary length, cm	42.1 ± 15.31	41.92 ± 14.94	<.05^b
Median tributary diameter, mm	4 (2-6)	2.3 (2-6)	<.05^a
Median sclerosant concentration, %	1 (0.5-3.0)	1 (0.5-1.0)	<.001^a
Median foam volume, mL	5 (1.5-8.0)	4 (1-9)	<.05^a

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CG, Concomitant treatment group; SG, staged treatment group.

Values are median (range), number (%), or mean ± standard deviation.

Boldface entries indicate statistical significance.

Mann-Whitney U test.

t-test.

Comparing the safety of FS between the groups, no serious adverse events were noted in either. However, there was a higher rate of hyperpigmentation in the CG at 6 months after EVLA (Table IV).

Table IV.

Comparison of complications in both groups

	CG	SG	P value	χ²
Inflammatory skin changes (persistent and prolonged skin and subcutaneous tissue inflammation)	6 (8)	5 (6)	.964	0.002
Temporary pigmentations after EVLA	18 (24)	13 (17)	.330	0.948
Pigmentations after FS (visible at 6 months after initial treatment)	33 (44)	19 (24)	.16	5779
Allergic reaction	1 (1)	1 (1)	Fisher's exact test = 0.742	–
Superficial vein thrombosis	5 (7)	10 (13)	.301	1070
Deep venous thrombosis	0	0	–	–

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CG, Concomitant treatment group; EVLA, endovenous laser ablation; FS, foam sclerotherapy; SG, staged treatment group.

Values are number (%)

Boldface entries indicate statistical significance.

In both treatment groups, no statistically significant relationship was found between the presence of the perforator incompetence and VV regression at 3 months (P = .943). Likewise, no significant association was observed at 6 months, likely due to the small number of patients without documented regression.

Discussion

In the light of these study results, both a concomitant and staged approach in patients undergoing EVLA combined with FS seem to be safe and effective methods for the treatment of GSV incompetence and its tributaries. Although concomitant treatment provides faster VV regression, a staged approach produces a better cosmetic result, decreasing the rate of sclerotherapy-related hyperpigmentation. These results add further evidence to the discussion concerning concomitant vs staged treatment.⁸^,¹³^,²⁰ In the study cohort, similar levels of patient satisfaction were obtained in both groups. Along with VV disappearance in both groups, comparable rVCSS results and improvements in the AVVQ were noted at the 6-month follow-up. Aherne et al² showed that, although concomitant treatment provides better QOL results in the first months after treatment, the difference in QOL diminishes as time advances, such that these outcomes are comparable in the SG and CG by 6 months after the procedure. The statistically significant improvement in QOL in both of our study groups was also confirmed when using CIVIQ-20 assessment; however, at the end of the follow-up (6 months), statistically better outcomes on the CIVIQ-20 evaluation were found in the CG. It should be noted that the CIVIQ-20 was primarily designed for patients undergoing pharmacological treatment of CVD; therefore, the interpretation of these results should done carefully in patients undergoing invasive treatment.²¹

In a randomized study conducted in the UK on a cohort of 798 patients, it was demonstrated that only 31% of those treated solely with EVLA of the GSV required additional intervention at the follow-up visit performed 6 weeks after the procedure. In contrast, among patients treated exclusively with FS (including FS of the GSV trunk), 38% qualified for reintervention due to the presence of residual varicosities.²² Similar to the findings presented in our study, the effectiveness of EVLA in the treatment of venous incompetence and VVs may be enhanced by the use of FS to obliterate tributaries and VVs. In a study conducted on 113 limbs, Watanabe et al²³ demonstrated that combining these two techniques during the same procedure allows safe and efficient management of VVs, with an acceptable risk of complications, while also reducing the need for reintervention following primary treatment (ablation).

FS is a valuable, widely used alternative to miniphlebectomy for lower-limb VVs, offering outpatient treatment without anesthesia, at a low cost, and with easy repeatability. Despite the overall low incidence of serious complications after sclerotherapy, one must nevertheless remember the range of local adverse events that may occur and are not always avoidable, even when the procedure is performed correctly. Common events include matting and hyperpigmentation; less common complications include skin necrosis and anaphylactic shock.³^,²⁴ The described rate of sclerotherapy-related hyperpigmentations ranges from 5% to 30% and can be potentially related to the several factors starting from the concentration of the sclerosing agent and its formulation (foam vs liquid) to the way the procedure is performed, as well as patient and treated vein characteristics.3, 4, 5^,²⁴ In the present study, hyperpigmentation was observed in 33 patients (44%) in the CG and 19 (25%) in the CG, with this difference being statistically significant. As documented in this study, postponing tributary treatment after truncal ablation can potentially lead to a decrease in the size of residual varicosities or even to their complete regression. In our study population of 36 patients (46%) in the SG group, none required further tributary treatment, which has been confirmed in several other studies.²^,⁵^,²⁵

As a result, the extent of phlebectomies or FS may be reduced and, in many cases, additional procedures become unnecessary.²⁵ The proportion of patients requiring repeat sclerotherapy or miniphlebectomy varies considerably between published studies.⁷^,¹²^,²⁵^,²⁶ Due to differences in patient expectations, health care and insurance policies, and the influence of current guidelines, the treatment strategy should always be discussed individually with each patient. In our nonrandomized study, patient participation in shared decision-making resulted in a high and comparable level of satisfaction in both treatment groups.

Despite several studies comparing staged and simultaneous treatment in patients undergoing truncal ablation with miniphlebectomy,⁶^,⁸^,²⁶ direct comparisons using the same strategy in patients treated with saphenous ablation and FS are still lacking. The results of our study may help in designing such a randomized controlled trial, which for now remains unavailable. In many centers, FS is the preferred therapeutic option over ambulatory phlebectomy in this clinical setting.¹³^,¹⁵^,²⁷ In a recent systematic review, Bossart et al²⁸ demonstrated that the frequency of hyperpigmentation varies widely across different drug concentrations, with higher concentrations consistently associated with higher reported rates of hyperpigmentation across various vein types. These findings underline a dose-dependent trend and indicate that careful selection of the lowest concentration capable of achieving clinical efficacy may be important in minimizing pigmentary changes.²⁸ Limiting both the concentration and the total injected volume to the lowest effective levels helps to reduce a broad range of complications, including thrombosis, matting, necrosis, and post-treatment hyperpigmentation. Taken together, these data support an approach to sclerotherapy that prioritizes conservative dosing strategies while preserving therapeutic effectiveness.²⁹^,³⁰ In our study, patients treated with staged FS required a significantly lower amount of foam and lower concentrations of the sclerosant; the number, length, and diameter of VVs requiring treatment were also notably lower. This factor may explain the significantly higher rate of hyperpigmentation in the CG. There were no significant differences in other complications after FS.

Patients opting for simultaneous treatment are usually motivated by the expectation of an immediate cosmetic effect and closure of both the insufficient main venous trunk and its varicosities during a single visit.¹³ A single-stage strategy shortens overall treatment time by managing the incompetent GSV and VVs in the same session. In many centers, this approach can decrease the total cost of treatment; however, as also documented in our study, in many cases of isolated truncal EVLA, additional treatment will be not required in the follow-up period. This, of course, requires patient consent and an understanding that, in some cases, additional treatment procedures focusing on VV treatment may be needed.³¹

Comparative studies suggest that simultaneous treatment is associated with better QOL outcomes and a lesser need for reintervention than staged therapy.⁶ In the present study, complete regression of VVs after EVLA alone occurred in 46% of patients, but published results vary widely. Wang et al¹³ reported that 95.3% of patients undergoing staged treatment required additional sclerotherapy, whereas simultaneous treatment (EVLA + FS) resulted in fewer residual varicosities at 6 months. Lane et al⁷ found markedly lower reintervention rates with single-stage compared with two-stage treatment (2% vs 36%). Monahan et al⁹ observed complete regression after EVLA alone in only 13% of patients, despite diameter reduction in most patients, supporting the concept that treating the main trunk may promote but not guarantee tributary regression. Obi et al²⁶ showed that single-stage GSV treatment led to more complications but greater rVCSS improvements in advanced disease, and other studies identified simultaneous treatment as an independent predictor of superior clinical improvement, despite more postoperative symptoms.¹¹ Although the European Society for Vascular Surgery guidelines recommend both miniphlebectomy and FS for incompetent tributaries, most evidence on treatment timing concerns phlebectomy, raising uncertainty about direct extrapolation to FS.⁵

This study has several limitations. The primary limitation of this study was its nonrandomized approach and patient preference contributing the choice of treatment. In this study, FS was the only adjunctive therapy; future studies should focus on FS and miniphlebectomy with a head-to-head comparison of the modalities. All study patients completed 6 months of follow-up. Longer follow-up is needed to determine the durability of complete VV regression, including cases resolving after EVLA alone. At the end of the follow-up period, no saphenous vein trunk or tributary incompetence related VVs were noticed in most patients in both groups. The relatively short follow-up from the initial treatment (6 months) should be extended in the further studies to evaluate the natural history of the untreated saphenous vein tributaries in patients with significant VV regression. Although there is no blinding of investigators during follow-ups in AVVQ, CIVIQ-20, and rVCSS assessment, the lack of significant pretreatment and post-treatment differences suggests that neither method was favored. Finally, the relatively small sample size limits the analysis of failures and complications, supporting the need for larger studies with extended follow-up.

Conclusions

Both simultaneous and delayed treatment approaches may result in favorable final outcomes and are associated with a comparable level of patient satisfaction, provided that patients are actively involved in the decision-making process regarding the choice of treatment for GSV incompetence and lower limb varicosities. Due to the possibility of achieving the desired clinical outcome rapidly, simultaneous treatment using EVLA combined with FS may be offered to patients who expect a prompt therapeutic effect without the need for further interventions. In contrast, for patients who will accept a longer treatment course and take into account the potential decrease in local complications and sequelae related to sclerotherapy, the selection of a delayed treatment strategy seems to be justified.

Author Contributions

Conception and design: MW, KW, TU

Analysis and interpretation: MW, KW, TU, GB, WK

Data collection: MW, KW

Writing the article: MW, KW, TU, GB, WK

Critical revision of the article: MW, KW, TU, GB, WK

Final approval of the article: MW, KW, TU, GB, WK

Statistical analysis: MW, TU

Obtained funding: MW, TU, WK

Overall responsibility: MW

Funding

Partially funded by Medical University of Silesia, Katowice, Poland (BNW-1-061/M/5/K). No involvement in the study design or collection, analysis, and interpretation of data. The university is involved in payment for publication. The university was not involved in the decision to submit the manuscript for publication.

Disclosures

None.

From the American Venous Forum

Footnotes

The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.

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22.Brittenden J., Cotton S.C., Elders A., et al. A randomized trial comparing treatments for varicose veins. N Engl J Med. 2014;371:1218–1227. doi: 10.1056/NEJMoa1400781. [DOI] [PubMed] [Google Scholar]
23.Watanabe S., Nishio S., Tsuji T., Fujita S., Kyo E. Effect of transluminal injection of foam sclerotherapy combined with endovenous thermal ablation of varicose veins. EJVES Vasc Forum. 2020;47:83–86. doi: 10.1016/j.ejvssr.2019.12.001. [DOI] [PMC free article] [PubMed] [Google Scholar]
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26.Obi A.T., Reames B.N., Rook T.J., et al. Outcomes associated with ablation compared to combined ablation and transilluminated powered phlebectomy in the treatment of venous varicosities. Phlebology. 2016;31:618–624. doi: 10.1177/0268355515604257. [DOI] [PubMed] [Google Scholar]
27.Zafarghandi M.R., Farsavian H., Davoudi M., Farsavian A.A. Outcome of ultrasonography-guided foam sclerotherapy versus stab avulsion ambulatory phlebectomy in the treatment of varicosis in small veins of the leg: a single blinded randomized clinical trial. Iranian J Radiol. 2017;14:1–4. doi: 10.5812/iranjradiol.21742. [DOI] [Google Scholar]
28.Bossart S., Daneluzzi C., Cazzaniga S., et al. Skin hyperpigmentation after sclerotherapy with polidocanol: a systematic review. J Eur Acad Dermatol Venereol. 2023;37:274–283. doi: 10.1111/jdv.18639. [DOI] [PubMed] [Google Scholar]
29.Mann M.W. Sclerotherapy – how to achieve a spectacular outcome. Phlebologie. 2020;49:204–210. doi: 10.1055/a-1195-4262. [DOI] [Google Scholar]
30.Ochoa A.J.G., Carrillo J., Manríquez D., Manrique F., Vazquez A.N. Reducing hyperpigmentation after sclerotherapy: a randomized clinical trial. J Vasc Surg Venous Lymphatic Disord. 2021;9:154–162. doi: 10.1016/j.jvsv.2020.06.019. [DOI] [PubMed] [Google Scholar]
31.Hirokawa M., Utoh J., Sugiyama S., et al. Supplement of clinical practice guidelines for endovenous thermal ablation for varicose veins 2019: laser ablation of varicose tributaries. Ann Vasc Dis. 2025;18:25. doi: 10.3400/avd.gl.25-00053. [DOI] [PMC free article] [PubMed] [Google Scholar]

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[bib12] 12.Mohamed A., Leung C., Hitchman L., et al. A prospective observational cohort study of concomitant versus sequential phlebectomy for tributary varicosities following axial mechanochemical ablation. Phlebology. 2019;34:627–635. doi: 10.1177/0268355519835625. [DOI] [PubMed] [Google Scholar]

[bib13] 13.Wang J.C., Li Y., Li G.Y., et al. A comparison of concomitant tributary laser ablation and foam sclerotherapy in patients undergoing truncal endovenous laser ablation for lower limb varicose veins. J Vasc Interv Radiol. 2018;29:781–789. doi: 10.1016/j.jvir.2018.01.774. [DOI] [PubMed] [Google Scholar]

[bib14] 14.Theivacumar N.S., Dellagrammaticas D., Beale R.J., Mavor A.I.D., Gough M.J. Factors influencing the effectiveness of endovenous laser ablation (EVLA) in the treatment of great saphenous vein reflux. Eur J Vasc Endovascular Surg. 2008;35:119–123. doi: 10.1016/j.ejvs.2007.08.010. [DOI] [PubMed] [Google Scholar]

[bib15] 15.Alder L.S., Rahi M.A. Single-visit endovenous laser treatment and tributary procedures for symptomatic great saphenous varicose veins. Ann R Coll Surg Engl. 2014;96:279–283. doi: 10.1308/003588414X13814021679474. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib16] 16.Zhang X., Wang X., Gao C., et al. A 1470-nm laser combined with foam sclerotherapy in day surgery: a better choice for lower limb varicose veins. Lasers Med Sci. 2018;33:1505–1511. doi: 10.1007/s10103-018-2507-8. [DOI] [PubMed] [Google Scholar]

[bib17] 17.Hauzer W., Gnus J., Rosińczuk J. Endovenous laser therapy with echosclerotherapy as a hybrid method for chronic venous insufficiency: experience in 200 patients and literature review. Eur Rev Med Pharmacol Sci. 2021;25:7777–7786. doi: 10.26355/eurrev_202112_27624. [DOI] [PubMed] [Google Scholar]

[bib18] 18.Karcioglu O., Topacoglu H., Dikme O., Dikme O. A systematic review of the pain scales in adults: which to use? Am J Emerg Med. 2018;36:707–714. doi: 10.1016/j.ajem.2018.01.008. [DOI] [PubMed] [Google Scholar]

[bib19] 19.Cavezzi A., Frullini A., Ricci S., Tessari L. Treatment of varicose veins by foam sclerotherapy: two clinical series. Phlebology. 2002;17:13–18. doi: 10.1007/s005230200023. [DOI] [Google Scholar]

[bib20] 20.Lane T.R.A., Onida S., Gohel M.S., Franklin I.J., Davies A.H. A systematic review and meta-analysis on the role of varicosity treatment in the context of truncal vein ablation. Phlebology. 2015;30:516–524. doi: 10.1177/0268355514548473. [DOI] [PubMed] [Google Scholar]

[bib21] 21.Launois R., Reboul-Marty J., Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ) Qual Life Res. 1996;5:539–554. doi: 10.1007/BF00439228. [DOI] [PubMed] [Google Scholar]

[bib22] 22.Brittenden J., Cotton S.C., Elders A., et al. A randomized trial comparing treatments for varicose veins. N Engl J Med. 2014;371:1218–1227. doi: 10.1056/NEJMoa1400781. [DOI] [PubMed] [Google Scholar]

[bib23] 23.Watanabe S., Nishio S., Tsuji T., Fujita S., Kyo E. Effect of transluminal injection of foam sclerotherapy combined with endovenous thermal ablation of varicose veins. EJVES Vasc Forum. 2020;47:83–86. doi: 10.1016/j.ejvssr.2019.12.001. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib24] 24.Wong M., Parsi K., Myers K., et al. Sclerotherapy of lower limb veins: indications, contraindications and treatment strategies to prevent complications – a consensus document of the International Union of Phlebology-2023. Phlebology. 2023;38:205–258. doi: 10.1177/02683555231151350. [DOI] [PubMed] [Google Scholar]

[bib25] 25.Wołkowski M., Kończyk B., Urbanek T. Staged or simultaneous varicose vein treatment after saphenous vein ablation. Chirurgia Polska. 2020;11:7–13. doi: 10.5603/ChP.2020.0002. [DOI] [Google Scholar]

[bib26] 26.Obi A.T., Reames B.N., Rook T.J., et al. Outcomes associated with ablation compared to combined ablation and transilluminated powered phlebectomy in the treatment of venous varicosities. Phlebology. 2016;31:618–624. doi: 10.1177/0268355515604257. [DOI] [PubMed] [Google Scholar]

[bib27] 27.Zafarghandi M.R., Farsavian H., Davoudi M., Farsavian A.A. Outcome of ultrasonography-guided foam sclerotherapy versus stab avulsion ambulatory phlebectomy in the treatment of varicosis in small veins of the leg: a single blinded randomized clinical trial. Iranian J Radiol. 2017;14:1–4. doi: 10.5812/iranjradiol.21742. [DOI] [Google Scholar]

[bib28] 28.Bossart S., Daneluzzi C., Cazzaniga S., et al. Skin hyperpigmentation after sclerotherapy with polidocanol: a systematic review. J Eur Acad Dermatol Venereol. 2023;37:274–283. doi: 10.1111/jdv.18639. [DOI] [PubMed] [Google Scholar]

[bib29] 29.Mann M.W. Sclerotherapy – how to achieve a spectacular outcome. Phlebologie. 2020;49:204–210. doi: 10.1055/a-1195-4262. [DOI] [Google Scholar]

[bib30] 30.Ochoa A.J.G., Carrillo J., Manríquez D., Manrique F., Vazquez A.N. Reducing hyperpigmentation after sclerotherapy: a randomized clinical trial. J Vasc Surg Venous Lymphatic Disord. 2021;9:154–162. doi: 10.1016/j.jvsv.2020.06.019. [DOI] [PubMed] [Google Scholar]

[bib31] 31.Hirokawa M., Utoh J., Sugiyama S., et al. Supplement of clinical practice guidelines for endovenous thermal ablation for varicose veins 2019: laser ablation of varicose tributaries. Ann Vasc Dis. 2025;18:25. doi: 10.3400/avd.gl.25-00053. [DOI] [PMC free article] [PubMed] [Google Scholar]

PERMALINK

Clinical trial of concomitant vs staged foam sclerotherapy of varicose veins following axial thermal ablation

Maciej Wołkowski, PhD

Tomasz Urbanek, PhD

Krzysztof Wołkowski, PhD

Grzegorz Biolik, PhD

Wacław Kuczmik, PhD