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

• Published in: Veins and lymphatics
• Main Authors: Martelli, Eugenio, Capoccia, Laura, Sotgiu, Giovanni, Saderi, Laura, Puci, Mariangela Valentina, Modugno, Piero, Furgiuele, Sergio, Aversano, Vincenzo, De Vivo, Salvatore, Iorio, Luca, Martelli, Allegra Rosa, Ricci, Stefano
• Format: Journal Article
• Language: English
• Published: PAGEPress Publications 25.01.2024
• Subjects: femoral vein; great saphenous vein; high ligation; neovascularization recurrences; varicose veins
• ISSN: 2279-7483; 2279-7483
• DOI: 10.4081/vl.2024.12146

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.