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Comparable effectiveness of endovenous laser ablation and high ligation with stripping of the great saphenous vein: two-year results of a randomized clinical trial (RELACS study).
Arch Dermatol. 2012 Jan; 148(1):49-58.AD

Abstract

OBJECTIVE

To compare the clinical efficacy and safety of endovenous laser treatment (EVLT) with high ligation and stripping (HLS) as standard treatment for great saphenous vein (GSV) insufficiency.

DESIGN

Two-center randomized controlled trial with 2-year follow-up.

SETTING

Interventions were performed on ambulatory and hospitalized patients at 2 vein centers, a university dermatology department (EVLT-treated group), and a specialized vein clinic (HLS-treated group).

PATIENTS

Random sample of 400 patients with GSV insufficiency.

INTERVENTIONS

Patients were assigned (1:1) to EVLT or HLS of the GSV from September 2004 through March 2007; 185 and 161 patients (limbs), respectively, were treated per protocol.

MAIN OUTCOME MEASURES

Clinically recurrent varicose veins after surgery (REVAS classification, primary study objective), duplex-detected saphenofemoral recurrence, clinical venous severity scoring (Homburg Varicose Vein Severity Score), hemodynamics (venous refilling time), quality of life (Chronic Venous Insufficiency Questionnaire 2), adverse effects, and visual analog scale-based evaluations of patients' satisfaction.

RESULTS

Clinically recurrent varicose veins after surgery were similarly observed in both groups: 16.2% (EVLT-treated group) vs 23.1% (HLS-treated group); P = .15. Duplex-detected saphenofemoral refluxes occurred significantly more frequently after EVLT (17.8% vs 1.3%; P < .001). Both treatments equally improved medical condition (Homburg Varicose Vein Severity Score) and disease-related quality of life. Endovenous laser treatment caused more adverse effects (phlebitic reaction, tightness, dyspigmentation) but revealed advantages concerning hemodynamics, recovery, and cosmetic outcome.

CONCLUSIONS

Both EVLT and HLS are comparably safe and effective procedures to treat GSV incompetence. The significantly higher rate and the course of duplex-detected saphenofemoral recurrences after EVLT remain a matter of further investigations.

TRIAL REGISTRATION

isrctn.org Identifier: ISRCTN18322872.

Authors+Show Affiliations

Department of Dermatology, Venerology and Allergology, Saarland University Hospital, 66421 Homburg, Germany. knuth.rass@uks.euNo affiliation info availableNo 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

21931012

Citation

Rass, Knuth, et al. "Comparable Effectiveness of Endovenous Laser Ablation and High Ligation With Stripping of the Great Saphenous Vein: Two-year Results of a Randomized Clinical Trial (RELACS Study)." Archives of Dermatology, vol. 148, no. 1, 2012, pp. 49-58.
Rass K, Frings N, Glowacki P, et al. Comparable effectiveness of endovenous laser ablation and high ligation with stripping of the great saphenous vein: two-year results of a randomized clinical trial (RELACS study). Arch Dermatol. 2012;148(1):49-58.
Rass, K., Frings, N., Glowacki, P., Hamsch, C., Gräber, S., Vogt, T., & Tilgen, W. (2012). Comparable effectiveness of endovenous laser ablation and high ligation with stripping of the great saphenous vein: two-year results of a randomized clinical trial (RELACS study). Archives of Dermatology, 148(1), 49-58. https://doi.org/10.1001/archdermatol.2011.272
Rass K, et al. Comparable Effectiveness of Endovenous Laser Ablation and High Ligation With Stripping of the Great Saphenous Vein: Two-year Results of a Randomized Clinical Trial (RELACS Study). Arch Dermatol. 2012;148(1):49-58. PubMed PMID: 21931012.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparable effectiveness of endovenous laser ablation and high ligation with stripping of the great saphenous vein: two-year results of a randomized clinical trial (RELACS study). AU - Rass,Knuth, AU - Frings,Norbert, AU - Glowacki,Paul, AU - Hamsch,Corinna, AU - Gräber,Stefan, AU - Vogt,Thomas, AU - Tilgen,Wolfgang, Y1 - 2011/09/19/ PY - 2011/9/21/entrez PY - 2011/9/21/pubmed PY - 2012/3/7/medline SP - 49 EP - 58 JF - Archives of dermatology JO - Arch Dermatol VL - 148 IS - 1 N2 - OBJECTIVE: To compare the clinical efficacy and safety of endovenous laser treatment (EVLT) with high ligation and stripping (HLS) as standard treatment for great saphenous vein (GSV) insufficiency. DESIGN: Two-center randomized controlled trial with 2-year follow-up. SETTING: Interventions were performed on ambulatory and hospitalized patients at 2 vein centers, a university dermatology department (EVLT-treated group), and a specialized vein clinic (HLS-treated group). PATIENTS: Random sample of 400 patients with GSV insufficiency. INTERVENTIONS: Patients were assigned (1:1) to EVLT or HLS of the GSV from September 2004 through March 2007; 185 and 161 patients (limbs), respectively, were treated per protocol. MAIN OUTCOME MEASURES: Clinically recurrent varicose veins after surgery (REVAS classification, primary study objective), duplex-detected saphenofemoral recurrence, clinical venous severity scoring (Homburg Varicose Vein Severity Score), hemodynamics (venous refilling time), quality of life (Chronic Venous Insufficiency Questionnaire 2), adverse effects, and visual analog scale-based evaluations of patients' satisfaction. RESULTS: Clinically recurrent varicose veins after surgery were similarly observed in both groups: 16.2% (EVLT-treated group) vs 23.1% (HLS-treated group); P = .15. Duplex-detected saphenofemoral refluxes occurred significantly more frequently after EVLT (17.8% vs 1.3%; P < .001). Both treatments equally improved medical condition (Homburg Varicose Vein Severity Score) and disease-related quality of life. Endovenous laser treatment caused more adverse effects (phlebitic reaction, tightness, dyspigmentation) but revealed advantages concerning hemodynamics, recovery, and cosmetic outcome. CONCLUSIONS: Both EVLT and HLS are comparably safe and effective procedures to treat GSV incompetence. The significantly higher rate and the course of duplex-detected saphenofemoral recurrences after EVLT remain a matter of further investigations. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN18322872. SN - 1538-3652 UR - https://www.unboundmedicine.com/medline/citation/21931012/Comparable_effectiveness_of_endovenous_laser_ablation_and_high_ligation_with_stripping_of_the_great_saphenous_vein:_two_year_results_of_a_randomized_clinical_trial__RELACS_study__ L2 - https://jamanetwork.com/journals/jamadermatology/fullarticle/10.1001/archdermatol.2011.272 DB - PRIME DP - Unbound Medicine ER -