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

Authors

Eugenio Martelli
eugenio.martelli@uniroma1.it
Department of General and Specialist Surgery, Faculty of Pharmacy and Medicine, Sapienza University of Rome; Saint Camillus International University of Health Sciences, Rome; Division of Vascular & Endovascular Surgery, Department of Surgery, S. Maria Goretti Hospital, Latina, Italy.
Laura Capoccia
Division of Vascular & Endovascular Surgery, Department of Cardiovascular Sciences, S. Anna and S. Sebastiano Hospital, Caserta, Italy.
Giovanni Sotgiu
Clinical Epidemiology and Medical Statistics Unit, Department of Medicine, Surgery and Pharmacy, University of Sassari, Italy.
Laura Saderi
Clinical Epidemiology and Medical Statistics Unit, Department of Medicine, Surgery and Pharmacy, University of Sassari, Italy.
Mariangela Valentina Puci
Clinical Epidemiology and Medical Statistics Unit, Department of Medicine, Surgery and Pharmacy, University of Sassari, Italy.
Piero Modugno
Division of Vascular Surgery, I.D.I. Hospital, Rome, Italy.
Sergio Furgiuele
Division of Vascular Surgery, Struttura Ospedaliera Mediterranea, Naples, Italy.
Vincenzo Aversano
Division of Angiology, Villa Fiorita Clinic, Capua (CE), Italy.
Salvatore De Vivo
Division of Vascular Surgery, Pellegrini Hospital, Naples, Italy.
Luca Iorio
Division of Vascular Surgery, Campobasso Hospital, Italy.
Allegra Rosa Martelli
Medicine and Surgery School of Medicine, Campus Bio-Medico University of Rome, Italy.
Stefano Ricci
Private practice in Phlebology, Rome, Italy.

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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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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