Crossotomy vs crossectomy for saphenous vein sparing surgery in patients with varicose veins due to ostial incontinence: protocol for double blind, multicenter, randomized trial

Submitted: 30 November 2023
Accepted: 16 January 2024
Published: 25 January 2024
Abstract Views: 876
PDF: 133
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Double‑blind/multicenter/randomized trial protocol. Eligibility criteria: age 18-70 yrs; C2-C5 leg varices secondary to the Great Saphenous Vein (GSV) incontinence; GSV size 6-10 mm, at 10 cm from the Saphenous-Femoral Junction (SFJ); ostial reflux lasting >0.5 sec at duplex ultrasound; negative reflux elimination test; acceptance of the GSV sparing treatment plus partial/total varicose veins removal. Exclusion criteria: non-isolated GSV reflux; district already treated; pregnancy/lactation; impaired walking ability; deep vein thrombosis/insufficiency; severe comorbidities. Participants recruited from 7 Italian tertiary referral centres. Interventions: crossotomy (no SFJ’s tributaries ligation) vs crossectomy. The study aimed to verify if GSV drainage through the SFJ’s tributaries reduces groin/peripheral recurrences. Primary endpoint: 1-year GSV reflux recurrence, positive to the Valsalva maneuver, originating from the SF. Participants equally randomized. Participants, care givers, and those assessing the outcomes blinded to group assignment.

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Citations

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Laura Saderi, Clinical Epidemiology and Medical Statistics Unit, Department of Medicine, Surgery and Pharmacy, University of Sassari
 

How to Cite

Martelli, E., Capoccia, L., Sotgiu, G., Saderi, L., Puci, M. V., Modugno, P., Furgiuele, S., Aversano, V., De Vivo, S., Iorio, L., Martelli, A. R., & Ricci, S. (2024). Crossotomy <i>vs</i> crossectomy for saphenous vein sparing surgery in patients with varicose veins due to ostial incontinence: protocol for double blind, multicenter, randomized trial. Veins and Lymphatics, 13. https://doi.org/10.4081/vl.2024.12146

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