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Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins.
Br J Surg. 2011 Apr; 98(4):501-10.BJ

Abstract

BACKGROUND

Endovenous laser ablation (EVLA) is a popular minimally invasive treatment for varicose veins. Surgical treatment, featuring junctional ligation and inversion stripping, has shown excellent clinical and cost effectiveness. The clinical effectiveness of both treatments was compared within a randomized trial.

METHODS

Some 280 patients were randomized equally into groups receiving either surgery or EVLA. Participants had primary, symptomatic, unilateral venous insufficiency, with isolated saphenofemoral junction incompetence, leading to reflux into the great saphenous vein. Outcomes included: quality of life (QoL), Venous Clinical Severity Score (VCSS), pain scores and time taken to return to normal function. Owing to the nature of the procedures, blinding was not possible.

RESULTS

Both groups had significant improvements in VCSS after treatment (P < 0.001), which resulted in improved disease-specific QoL (Aberdeen Varicose Vein Questionnaire, P < 0.001) and quality-adjusted life year (QALY) gain (P < 0.001). The pain and disability following surgery impaired normal function, with a significant decline in five of eight Short Form 36 (SF-36(®)) domains (P < 0.001 to P = 0.029). Periprocedural QoL was relatively preserved following EVLA, leading to a significant difference between the two treatments in pain scores (P < 0.001), six of eight SF-36(®) domains (P = 0.004 to P = 0.049) and QALYs (P = 0.003). As a result, surgical patients took longer to return to work and normal activity (14 versus 4 days; P < 0.001). Complications were rare.

CONCLUSION

EVLA was as effective as surgery for varicose veins, but had a less negative impact on early postintervention QoL.

REGISTRATION NUMBER

NCT00759434 (http://www.clinicaltrials.gov).

Authors+Show Affiliations

Academic Vascular Surgical Unit, University of Hull, Hull, UK. dan1@doctors.org.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

21283981

Citation

Carradice, D, et al. "Randomized Clinical Trial of Endovenous Laser Ablation Compared With Conventional Surgery for Great Saphenous Varicose Veins." The British Journal of Surgery, vol. 98, no. 4, 2011, pp. 501-10.
Carradice D, Mekako AI, Mazari FA, et al. Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg. 2011;98(4):501-10.
Carradice, D., Mekako, A. I., Mazari, F. A., Samuel, N., Hatfield, J., & Chetter, I. C. (2011). Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. The British Journal of Surgery, 98(4), 501-10. https://doi.org/10.1002/bjs.7394
Carradice D, et al. Randomized Clinical Trial of Endovenous Laser Ablation Compared With Conventional Surgery for Great Saphenous Varicose Veins. Br J Surg. 2011;98(4):501-10. PubMed PMID: 21283981.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. AU - Carradice,D, AU - Mekako,A I, AU - Mazari,F A K, AU - Samuel,N, AU - Hatfield,J, AU - Chetter,I C, Y1 - 2011/01/31/ PY - 2010/11/18/accepted PY - 2011/2/2/entrez PY - 2011/2/2/pubmed PY - 2011/6/28/medline SP - 501 EP - 10 JF - The British journal of surgery JO - Br J Surg VL - 98 IS - 4 N2 - BACKGROUND: Endovenous laser ablation (EVLA) is a popular minimally invasive treatment for varicose veins. Surgical treatment, featuring junctional ligation and inversion stripping, has shown excellent clinical and cost effectiveness. The clinical effectiveness of both treatments was compared within a randomized trial. METHODS: Some 280 patients were randomized equally into groups receiving either surgery or EVLA. Participants had primary, symptomatic, unilateral venous insufficiency, with isolated saphenofemoral junction incompetence, leading to reflux into the great saphenous vein. Outcomes included: quality of life (QoL), Venous Clinical Severity Score (VCSS), pain scores and time taken to return to normal function. Owing to the nature of the procedures, blinding was not possible. RESULTS: Both groups had significant improvements in VCSS after treatment (P < 0.001), which resulted in improved disease-specific QoL (Aberdeen Varicose Vein Questionnaire, P < 0.001) and quality-adjusted life year (QALY) gain (P < 0.001). The pain and disability following surgery impaired normal function, with a significant decline in five of eight Short Form 36 (SF-36(®)) domains (P < 0.001 to P = 0.029). Periprocedural QoL was relatively preserved following EVLA, leading to a significant difference between the two treatments in pain scores (P < 0.001), six of eight SF-36(®) domains (P = 0.004 to P = 0.049) and QALYs (P = 0.003). As a result, surgical patients took longer to return to work and normal activity (14 versus 4 days; P < 0.001). Complications were rare. CONCLUSION: EVLA was as effective as surgery for varicose veins, but had a less negative impact on early postintervention QoL. REGISTRATION NUMBER: NCT00759434 (http://www.clinicaltrials.gov). SN - 1365-2168 UR - https://www.unboundmedicine.com/medline/citation/21283981/Randomized_clinical_trial_of_endovenous_laser_ablation_compared_with_conventional_surgery_for_great_saphenous_varicose_veins_ L2 - https://doi.org/10.1002/bjs.7394 DB - PRIME DP - Unbound Medicine ER -