Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein

Lam, Yee Lai; Lawson, James A.; Toonder, Irwin M.; Shadid, Nadia H; Sommer, A.; Veenstra, Martine S; Kleij, A M J van der; Ceulen, R.P.M.; Haan, E de; Ibrahim, Fowzia; Dooren, Tessa van; Nieman, Fred; Wittens, Cees H. A.

doi:10.1002/bjs.10762

Cited by 23 publications

(17 citation statements)

References 20 publications

(20 reference statements)

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“…173 An eight-year randomized comparative trial published in 2018 showed that stripping compared to sclerotherapy of the GSV led to a better anatomical success and less symptoms recurrence, yet with no significant differences at the EQ-5D standardized measure of health status. 174 On this topic, in 2019, Kalodiki et al published a discord outcome analysis comparing endovenous laser ablation and foam sclerotherapy for GSV reflux treatment, including evaluation of change in Aberdeen Varicose Veins Questionnaire (AVVQ), Venous Clinical Severity Score (VCSS) and Venous Filling Index (VFI). Interestingly, at 68 months, no significant differences in VCSS and VFI were found, while the laser group had an improvement in AVVQ.…”

Section: Significant New Data Reported At the Meetingmentioning

confidence: 99%

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Global guidelines trends and controversies in lower limb venous and lymphatic disease

et al. 2019

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Guidelines are fundamental in addressing everyday clinical indications and in reporting the current evidence-based data of related scientific investigations. At the same time, a spatial and temporal issue can limit their value. Indeed, variability in the recommendations can be found both among the same nation different scientific societies and among different nations/continents. On the other side, Garcia already published in 2014 data showing how, after three years in average, one out of five recommendations gets outdated (Martinez Garcia LM, Sanabria AJ, Garcia Alvarez E, et al. The validity of recommendations from clinical guidelines: a survival analysis. CMAJ 2014;186(16):1211–1219). The present document reports a narrative literature revision on the major international recommendations in lower limb venous and lymphatic disease management, focusing on the different countries’ guidelines, trends and controversies from all the continents, while identifying new evidence-based data potentially influencing future guidelines. World renowned experts’ opinions are also provided. The document has been written following the recorded round tables scientific discussions held at the vWINter international meeting (22–26 January 2019; Cortina d’Ampezzo, Italy) and the pre- and post-meeting literature search performed by the leading experts.

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Section: Significant New Data Reported At the Meetingmentioning

confidence: 99%

“…An eight-year randomized comparative trial published in 2018 showed that stripping compared to sclerotherapy of the GSV led to a better anatomical success and less symptoms recurrence, yet with no significant differences at the EQ-5D standardized measure of health status. 174…”

Section: Sclerotherapy For Varicose Veinsmentioning

confidence: 99%

Global guidelines trends and controversies in lower limb venous and lymphatic disease

et al. 2019

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“…Angaben zu Ausschlusskriterien, wie z. B. insuffiziente Vena accessoria der VSM [20], oder zusätzlichen Eingriffen, wie Phlebektomie oder Perforansligatur, sind in der Analyse nicht berücksichtigt.…”

Section: Ergebnisseunclassified

“…Crosseninsuffizienz lag nach UGFS bei 65,8 % und nach HL + CS bei 41,7 % (p = 0,001) vor. Rezidiv-Reflux oberhalb des Knies trat nach UGFS (72,55 %) häufiger als nach HL + CS (20,4 %; p = 0,001) auf [20].…”

Section: Ergebnisse Der Chirurgischen Behandlungunclassified

Treatment of varicose great saphenous veins with saphenofemoral junction insufficiency – what is the evidence? *

2020

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The results of studies on treatment of the great saphenous vein (GSV) with sapheno-femoral-junction (SFJ) insufficiency are unclear. Guidelines, however, recommend endovenous laser ablation (EVLA) and ultrasound-guided-foamsclerotherapy (UGFS) for symptomatic varicose large saphenous vein. There are numerous studies on GSV treatment but only a few randomized studies with a follow-up of two years and more. Meta-analyses in most instances included all studies and do not focus on studies with a follow-up of two years and longer. Methods A literature research in Pubmed used the keyword “great saphenous vein treatment”, “large saphenous vein treatment”, “varicose therapy” in conjunction with “randomized controlled trial”, “meta-analysis” and “systematic review”. Of 128 studies only 24 randomized controlled studies investigated the effect of High Ligation and Continuous Stripping (HL + CS), Endovenous Laser Ablation (EVLA), Radiofrequency Ablation (RFA), Liquid Sclerotherapy (LS), and Ultrasound-Guided-Foam-Sclerotherapy (UGFS) and a follow-up of two and more years. Study evaluation included “reflux”, “recurrence”, “therapy technique”, numbers of patients/legs treated, length of follow-up, and primary/secondary study endpoints. Results Most of these studies investigated surgical High Ligation and Continuous Stripping (HL + CS) with a follow-up of two years and more. This technique served a reference technique for other techniques in randomized controlled studies. However, there are major differences in techniques, mode of treatment, definitions, criteria for exclusion and inclusion, and study endpoints.The surgery study group included 1915 legs in 19 studies, the EVLA group 1047 legs in 12 studies and 240 legs in 3 studies with combined HL + EVLA treatment. RFA was used in 299 legs in 4 studies, UGFS in 661 legs in 5 studies, combined UGFS + HL in 39 legs and LS + HL in 92 legs in one study each.EVLA is associated with more reflux and recurrence when compared to HL + CS. RFA shows similar reflux and recurrence rates as surgery. In most studies UGFS and LS is followed by more reflux and recurrence when compared to surgery. Conclusion Due to heterogeneity of studies comparing study results of HL + CS, EVLA, RFA, LS and UGFS is not reliable. UIP or ECOP may form a commission to establish uniform, reliable and accepted study designs for varicose vein treatment to improve comparability of further randomized studies.

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“…Out of these STD and polidocanol (POL) are safe and most commonly used. [2][3][4][5][6] In this study we have compared early outcomes in patients having any one of these two sclerosants viz. STD and POL in the treatment of varicosities of tributaries of GSV and SSV.…”

mentioning

confidence: 99%

A study to compare outcomes of Sodium tetra-decyl sulphate and Polidocanol in the treatment of varicosities due to incompetent tributaries of superficial vein of leg: a randomized controlled trial

et al. 2018

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Background: Various options for treatment of varicosities of tributaries are mini-phlebectomy, hook phlebectomy, Trivex and sclerotherapy. Sodium tetra-decyl sulphate (STD) and polidocanol (POL) are most commonly used sclerosants. Adverse events caused by sclerosants are pain, thrombophlebitis, hyperpigmentation, allergy, anaphylactic shock, cutaneous necrosis, deep venous thrombosis, headache, visual disturbances and chest tightness. Foam sclerotherapy has been considered to be better than liquid sclerosant. In this study we have compared foam prepared by STD versus POL in the treatment of varicosities of tributaries of superficial vein of Leg.Methods: Patients treated for SFJ or SPJ incompetency post their primary admission and management were attended and evaluated in outpatient department. Patients having varicosities were enrolled for study and treated in OPD by foam sclerotherapy. Patients were randomized to two groups - A or B. Patients were followed up for one month and various clinical outcomes were analyzed.Results: In group A (STD) out of n=20 patients pain, hyperpigmentation and skin necrosis was present in n1=18 patients, n2=14 patients and in n3=2 patients respectively on the first post-operative day while in group B (POL) out of 24 patients it was present in n1=14, n2=8 and n3=1 patient respectively. Post sclerotherapy at one month follow up, in Group A pain and hyperpigmentation decreased to n1=08 and n2=04 patients respectively but skin necrosis was persisting in all n3=02 patients. In-group B pain and hyperpigmentation was present in patients each n1= n2=02 and skin necrosis was present in n3=01 patient.Conclusions: Polidocanol is better than Sodium tetra-decyl sulphate for foam sclerotherapy in terms of better cosmetic outcomes.

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Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein

Cited by 23 publications

References 20 publications

Global guidelines trends and controversies in lower limb venous and lymphatic disease

Global guidelines trends and controversies in lower limb venous and lymphatic disease

Treatment of varicose great saphenous veins with saphenofemoral junction insufficiency – what is the evidence? *

A study to compare outcomes of Sodium tetra-decyl sulphate and Polidocanol in the treatment of varicosities due to incompetent tributaries of superficial vein of leg: a randomized controlled trial

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