Abstract
BackgroundSeveral modalities are used for the treatment of varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates. Despite this, there is the possibility of thermal injury to surrounding structures. The recently introduced cyanoacrylate closure is also considered to be a good alternative and the risk of injury to surrounding structures is minimal. The purpose of this study is to demonstrate the non-inferiority of cyanoacrylate closure with the VenaSeal™ closure system compared to surgical stripping in terms of clinical outcomes for the treatment of incompetent great saphenous veins.Methods/designThis is an open-label, multicenter, prospective, randomized controlled trial evaluating the non-inferior clinical outcomes of cyanoacrylate closure compared to surgical stripping for the treatment of incompetent saphenous veins. After baseline measurements, participants will be randomly allocated into either the cyanoacrylate closure group or the surgical-stripping group. The primary endpoint of the study is the complete closure rate of the target vein in the cyanoacrylate closure group, and the absence of venous reflux or residual venous tissue after surgical stripping in the surgical-stripping group. These endpoints will be measured by Doppler ultrasound performed by qualified vascular technologists or investigators at 3 months after treatment. Secondary outcomes include perioperative pain, postoperative ecchymosis, clinical assessment (including general and disease-specific quality of life evaluations), complete closure rate, and absence of venous reflux or residual venous tissue at the 12- and 24-month follow-ups, as well as all adverse event rates during the 24-month follow-up period.DiscussionThis multicenter randomized controlled trial is designed to show non-inferiority in terms of complete closure rate of cyanoacrylate compared to surgical stripping for the treatment of incompetent saphenous veins.Trial registrationClinical Research Information Service (CRIS), ID: KCT0003203. Registered on 20 September 2018.
Highlights
Several modalities are used for the treatment of varicose veins
Secondary outcomes include perioperative pain, postoperative ecchymosis, clinical assessment, complete closure rate, and absence of venous reflux or residual venous tissue at the 12and 24-month follow-ups, as well as all adverse event rates during the 24-month follow-up period. This multicenter randomized controlled trial is designed to show non-inferiority in terms of complete closure rate of cyanoacrylate compared to surgical stripping for the treatment of incompetent saphenous veins
Statistical considerations The purpose of this study is to evaluate the noninferiority of cyanoacrylate closure to surgical stripping in the treatment of incompetent saphenous veins
Summary
Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates. Endovenous thermal ablation by radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) is a safe and effective alternative with good long-term target-vein closure rates [2]. The results of these endovenous thermal ablations, even in some of the randomized clinical trials compared to previous surgical methods, have consistently been excellent [3, 4]. The use of tumescent anesthesia is a prerequisite in order to prevent thermal injury; this is time-consuming and has side effects such as pain, ecchymosis, and hematoma formation [5, 6]
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