Randomized clinical trial of ultrasound-guided foam sclerotherapy <i>versus</i> surgery for the incompetent great saphenous vein

Shadid, Nadia H; Ceulen, R.P.M.; Nelemans, Patty J.; Dirksen, Carmen D.; Veraart, J. C. J. M.; Schurink, G.W.H.; Neer, Pierre van; Kley, J vd; Haan, E de; Sommer, A.

doi:10.1002/bjs.8781

Cited by 116 publications

(100 citation statements)

References 29 publications

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“…Twelve of the 34 included trials failed adequately to report methods of either randomisation or allocation concealment, or reported inadequate methods. [77][78][79][80]83,98,101,114,117,[120][121][122] Two further trials reported adequate randomisation but inadequate allocation concealment. 97,100 These studies, as reported, therefore had a high risk of selection bias.…”

Section: Quality Of Included Studiesmentioning

confidence: 99%

“…97,100 These studies, as reported, therefore had a high risk of selection bias. Thirteen studies either clearly failed to conduct an intention-to-treat analysis or left it unclear whether or not they had done so, and so were categorised as not clearly conducting such an analysis; 42,53,55,77,79,80,88,91,102,114,117,122,124 six of these also failed to report adequate methods of randomisation and allocation concealment, 77,79,80,114,117,122 all but one of which were abstracts only. 114 Two further key criteria were assessed that had the greatest potential to confound the results of this report: the non-comparability of groups at baseline and non-identical care programmes post intervention.…”

Section: Quality Of Included Studiesmentioning

confidence: 99%

“…reported data on technical recurrence within 6 months of treatment (see Table 12). Twenty-one trials 43,53,55,77,81,82,85,87,[95][96][97][99][100][101]115,117,120,122,[124][125][126] reported technical recurrence data for follow-ups of ≥ 6 months (see Table 13). Data from all follow-up time points in the following trial arms were included in the analysis (see Assessment of effectiveness): EVLA, RFA, FS and conventional surgery (ligation and stripping).…”

Section: Failure Of Proceduresmentioning

confidence: 99%

“…Return to work or normal activity 77 Rasmussen et al 95 and Shadid et al 122 ) also had the largest sample sizes of all included studies in the review. This might suggest that these outcomes are rare events that the smaller studies were not powerful enough to detect, although the event rate in Wright et al 77 was substantially higher than in any other study.…”

Section: Pain Scorementioning

confidence: 99%

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Clinical effectiveness and cost-effectiveness of minimally invasive techniques to manage varicose veins: a systematic review and economic evaluation

Carroll

Hummel²,

Leaviss³

et al. 2013

Health Technology Assessment

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Section: Quality Of Included Studiesmentioning

confidence: 99%

Section: Quality Of Included Studiesmentioning

confidence: 99%

Section: Failure Of Proceduresmentioning

confidence: 99%

Section: Pain Scorementioning

confidence: 99%

See 2 more Smart Citations

Clinical effectiveness and cost-effectiveness of minimally invasive techniques to manage varicose veins: a systematic review and economic evaluation

Carroll

Hummel²,

Leaviss³

et al. 2013

Health Technology Assessment

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“…There are no limitations to using the technique after relapses, since in cases of recanalization the same patients can be treated again with the same method. 10 Polidocanol, in the form of foam, is the agent generally used in this type of treatment and it is painless and has a low incidence of allergic reactions. Treatment success rates have been reported by Gonzalez-Zeh et al,…”

Section: Introductionmentioning

confidence: 99%

Impacto da escleroterapia com espuma de polidocanol guiada por ultrassom em pacientes com úlcera venosa

Silva¹,

Araujo²,

Amaral³

et al. 2017

J. vasc. bras.

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Background: Ultrasound-guided polidocanol foam sclerotherapy is used to treat patients with venous ulcers. It is a minimally invasive procedure and is simple to perform, but it has high relapse rates. Objectives: To report short to medium term results in patients with venous ulcers treated using ultrasound-guided polidocanol foam sclerotherapy. Methods: A sample of 19 patients who had been treated with ultrasound-guided polidocanol foam sclerotherapy between January 2013 and December 2014 were followed-up. Time taken for ulcers to heal, improvement of clinical symptoms, recanalization of treated veins, and relapse of symptoms and of venous ulcers were analyzed. Results: Fifteen of the patients analyzed were female (78.9%) and four were male (21.1%). Overall mean age was 53 years. Follow-up times ranged from 448 days to 1,276 days (mean of 791 days). The mean duration of active ulcers was 53 months. At postoperative follow-up assessments, total recanalization was observed in 15.7%, partial recanalization in 21%, and occlusion in 47.3% of the veins that had been treated. There was only one case of ulcer relapse. Analysis of mean Venous Clinical Severity Scores (VCSS) revealed a significant difference from before to after the procedure, with a variation of 11.2 (p < 0.01). Conclusions: Ultrasound-guided foam sclerotherapy has high rates of therapeutic success and achieves high rates of venous ulcer healing.

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Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional surgery for great saphenous vein varices

Nesbitt

Bedenis

Bhattacharya³

et al. 2011

Cochrane Database of Systematic Reviews

100

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BACKGROUND: Minimally invasive techniques to treat great saphenous varicose veins include ultrasound-guided foam sclerotherapy (USGFS), radiofrequency ablation (RFA) and endovenous laser therapy (EVLT). Compared with conventional surgery (high ligation and stripping (HL/S)), proposed benefits include fewer complications, quicker return to work, improved quality of life (QoL) scores, reduced need for general anaesthesia and equivalent recurrence rates. OBJECTIVE: To review available randomized controlled clinical trials (RCT) data comparing USGFS, RFA, EVLT to HL/S for the treatment of great saphenous varicose veins. METHODS: Search methods: The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialized Register (July 2010) and CENTRAL (The Cochrane Library 2010, Issue 3). In addition the authors performed a search of EMBASE (July 2010). Manufacturers of EVLT, RFA and sclerosant equipment were contacted for trial data. Selection criteria: All RCTs of EVLT, RFA, USGFS and HL/S were considered for inclusion. Primary outcomes were recurrent varicosities, recanalization, neovascularization, technical procedure failure or need for reintervention, patient quality of life (QoL) scores and associated complications. Secondary outcomes were type of anaesthetic, procedure duration, hospital stay and cost. Data collection and analysis: CN, RE, VB, PC, HB and GS independently reviewed, assessed and selected trials which met the inclusion criteria. CN and RE extracted data. The Cochrane Collaboration's tool for assessing risk of bias was used. CN contacted trial authors to clarify details. MAIN RESULTS: Thirteen reports from five studies with a combined total of 450 patients were included. Rates of recanalization were higher following EVLT compared with HL/S, both early (within four months) (5/149 versus 0/100; odds ratio (OR) 3.83, 95% confidence interval (CI) 0.45 to 32.64) and late recanalization (after four months) (9/118 versus 1/80; OR 2.97; 95% CI 0.52 to 16.98), although these results were not statistically significant. Technical failure rates favoured EVLT over HL/S (1/149 versus 6/100; OR 0.12, 95% CI 0.02 to 0.75). Recurrence following RFA showed no difference when compared with surgery. Recanalization within four months was observed more frequently following RFA compared with HL/S although not statistically significant (4/105 versus 0/88; OR 7.86, 95% CI 0.41 to 151.28); after four months no difference was observed. Neovascularization was observed more frequently following HL/S compared with RFA, but again this was not statistically significant (3/42 versus 8/51; OR 0.39, 95% CI 0.09 to 1.63). Technical failure was observed less frequently follow

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Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein

Cited by 116 publications

References 29 publications

Clinical effectiveness and cost-effectiveness of minimally invasive techniques to manage varicose veins: a systematic review and economic evaluation

Clinical effectiveness and cost-effectiveness of minimally invasive techniques to manage varicose veins: a systematic review and economic evaluation

Impacto da escleroterapia com espuma de polidocanol guiada por ultrassom em pacientes com úlcera venosa

Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional surgery for great saphenous vein varices

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