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

Abstract

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 6-10mm, at 10cm 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.