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Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction.
Eur J Vasc Endovasc Surg. 2011 May; 41(5):685-90.EJ

Abstract

OBJECTIVE

To evaluate whether ligation of the saphenofemoral junction (SFL) improves the results of endovenous laser ablation (EVLA) of the great saphenous vein (GSV) in a 5-year randomised clinical trial (RCT).

METHODS

Forty-three symptomatic patients (86 limbs) with bilateral incompetent GSVs were randomised so that one limb underwent EVLA without SFL and the other limb underwent EVLA with SFL. Eleven patients were lost to follow-up and two patients died, leaving 30 patients (60 limbs) for analysis. Duplex-confirmed groin varicose vein recurrence and venous clinical severity score (VCSS) were investigated at 6, 12, 24 and 60 months after treatment.

RESULTS

Five-year life table analysis showed freedom from groin varicose vein recurrence in 79% of limbs (95% confidence interval (CI); 67-92%) in the EVLA without SFL group and in 65% of limbs (95%; CI; 51-82) in the EVLA with SFL group (P = 0.36). Groin varicose vein recurrence was due to neo-vascularisation (0%), re-canalisation (9%) and incompetent tributaries in 14% in the EVLA without SFL group, and to neo-vascularisation (33%), re-canalisation (0%) and incompetent tributaries (0%) in the EVLA with SFL group. The VCSS improved significantly and was comparable in both groups.

CONCLUSION

The rate of varicose vein recurrence was similar in both study groups. There was less neo-vascularisation in the EVLA without SFL group, but more incompetent tributaries and early re-canalisation at 5-year follow-up than in the EVLA with SFL group.

REGISTRATION NUMBER

ISRCTN60300873 (http://www.clinical-trials.com).

Authors+Show Affiliations

Department of Surgery, Bergmankliniek, Bilthoven, The Netherlands. disselhoff@ziggo.nlNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

21333560

Citation

Disselhoff, B C V M., et al. "Five-year Results of a Randomised Clinical Trial of Endovenous Laser Ablation of the Great Saphenous Vein With and Without Ligation of the Saphenofemoral Junction." European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery, vol. 41, no. 5, 2011, pp. 685-90.
Disselhoff BC, der Kinderen DJ, Kelder JC, et al. Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction. Eur J Vasc Endovasc Surg. 2011;41(5):685-90.
Disselhoff, B. C., der Kinderen, D. J., Kelder, J. C., & Moll, F. L. (2011). Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction. European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery, 41(5), 685-90. https://doi.org/10.1016/j.ejvs.2010.12.014
Disselhoff BC, et al. Five-year Results of a Randomised Clinical Trial of Endovenous Laser Ablation of the Great Saphenous Vein With and Without Ligation of the Saphenofemoral Junction. Eur J Vasc Endovasc Surg. 2011;41(5):685-90. PubMed PMID: 21333560.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction. AU - Disselhoff,B C V M, AU - der Kinderen,D J, AU - Kelder,J C, AU - Moll,F L, Y1 - 2011/02/18/ PY - 2010/09/26/received PY - 2010/12/09/accepted PY - 2011/2/22/entrez PY - 2011/2/22/pubmed PY - 2011/6/29/medline SP - 685 EP - 90 JF - European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery JO - Eur J Vasc Endovasc Surg VL - 41 IS - 5 N2 - OBJECTIVE: To evaluate whether ligation of the saphenofemoral junction (SFL) improves the results of endovenous laser ablation (EVLA) of the great saphenous vein (GSV) in a 5-year randomised clinical trial (RCT). METHODS: Forty-three symptomatic patients (86 limbs) with bilateral incompetent GSVs were randomised so that one limb underwent EVLA without SFL and the other limb underwent EVLA with SFL. Eleven patients were lost to follow-up and two patients died, leaving 30 patients (60 limbs) for analysis. Duplex-confirmed groin varicose vein recurrence and venous clinical severity score (VCSS) were investigated at 6, 12, 24 and 60 months after treatment. RESULTS: Five-year life table analysis showed freedom from groin varicose vein recurrence in 79% of limbs (95% confidence interval (CI); 67-92%) in the EVLA without SFL group and in 65% of limbs (95%; CI; 51-82) in the EVLA with SFL group (P = 0.36). Groin varicose vein recurrence was due to neo-vascularisation (0%), re-canalisation (9%) and incompetent tributaries in 14% in the EVLA without SFL group, and to neo-vascularisation (33%), re-canalisation (0%) and incompetent tributaries (0%) in the EVLA with SFL group. The VCSS improved significantly and was comparable in both groups. CONCLUSION: The rate of varicose vein recurrence was similar in both study groups. There was less neo-vascularisation in the EVLA without SFL group, but more incompetent tributaries and early re-canalisation at 5-year follow-up than in the EVLA with SFL group. REGISTRATION NUMBER: ISRCTN60300873 (http://www.clinical-trials.com). SN - 1532-2165 UR - https://www.unboundmedicine.com/medline/citation/21333560/Five_year_results_of_a_randomised_clinical_trial_of_endovenous_laser_ablation_of_the_great_saphenous_vein_with_and_without_ligation_of_the_saphenofemoral_junction_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1078-5884(10)00787-2 DB - PRIME DP - Unbound Medicine ER -