Crossotomy vs crossectomy for saphenous vein sparing surgery in patients with varicose veins due to ostial incontinence: protocol for double blind, multicenter, randomized trial
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 re...
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Published in | Veins and lymphatics |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
PAGEPress Publications
25.01.2024
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Subjects | |
Online Access | Get full text |
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Summary: | 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. |
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ISSN: | 2279-7483 2279-7483 |
DOI: | 10.4081/vl.2024.12146 |