This study evaluates whether calcium dobesilate, a venoactive drug, improves recovery after radiofrequency ablation (RFA) for varicose veins. Patients with great saphenous vein insufficiency undergoing RFA will be randomly assigned to receive either calcium dobesilate (500 mg twice daily) or standard care alone. The treatment starts 7 days before the procedure and continues for 30 days after. The primary outcome is postoperative pain at day 7. Secondary outcomes include pain at days 14 and 30, quality of life, ecchymosis, and return to daily activities.
Radiofrequency ablation (RFA) is a minimally invasive treatment for great saphenous vein insufficiency. Although effective, patients may experience postprocedural pain, ecchymosis, and discomfort during recovery. Venoactive drugs have been shown to reduce symptoms in chronic venous disease and may improve recovery after venous procedures. Calcium dobesilate is a venoactive agent that reduces capillary permeability, inhibits platelet aggregation, and has anti-inflammatory properties. It is approved for chronic venous insufficiency treatment in many countries including Turkey. This prospective, randomized, open-label, controlled trial will investigate whether perioperative calcium dobesilate administration improves clinical outcomes after RFA. Approximately 100 patients will be enrolled and randomized 1:1 to either: * Intervention group: Calcium dobesilate 500 mg twice daily starting 7 days before RFA and continuing for 30 days postoperatively, plus standard care * Control group: Standard care alone (RFA plus compression stockings) All patients will undergo standardized RFA procedure under tumescent anesthesia. Assessments will be performed at baseline, and postoperative days 1, 7, 14, 30, and 90. Primary endpoint is pain score (VAS) at day 7. Secondary endpoints include VCSS, CIVIQ-20 quality of life score, ecchymosis score, analgesic use, and time to return to normal activities.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
250
Calcium dobesilate 500 mg oral tablet, twice daily (morning and evening), starting 7 days before radiofrequency ablation and continuing for 30 days postoperatively. Total treatment duration is 37 days.
Zonguldak Bulent Ecevit University Hospital, Department of Cardiovascular Surgery
Kozlu, Zonguldak Province, Turkey (Türkiye)
Postoperative Pain Score (VAS)
Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain)
Time frame: Postoperative day 7
Postoperative Pain Score at Day 14 and Day 30
Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 to 10
Time frame: Postoperative day 14 and day 30
Venous Clinical Severity Score (VCSS)
Clinical assessment of venous disease severity using standardized VCSS scoring system (0-30 points)
Time frame: Baseline, day 30, and day 90
Quality of Life (CIVIQ-20)
Disease-specific quality of life measured using Chronic Venous Insufficiency Questionnaire (CIVIQ-20)
Time frame: Baseline, day 14, day 30, and day 90
Ecchymosis Score
Postoperative bruising assessed using a 5-point scale (0=none, 1=\<5cm, 2=5-10cm, 3=10-20cm, 4=\>20cm)
Time frame: Postoperative day 1, day 7, and day 14
Time to Return to Normal Activities
Number of days until patient returns to normal daily activities and work
Time frame: Up to 30 days postoperatively
Postoperative Paresthesia Incidence
Presence and severity of numbness, tingling, or sensory changes along the treated vein assessed using a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: Postoperative day 7, day 30, and day 90
Endovenous Heat-Induced Thrombosis (EHIT) Incidence
Presence and grade of thrombus extension into the deep venous system assessed by duplex ultrasound using Lawrence classification (Class 1-4)
Time frame: Postoperative day 7
Great Saphenous Vein Occlusion Rate
Complete occlusion of treated great saphenous vein confirmed by duplex ultrasound (absence of flow and compressibility)
Time frame: Postoperative day 30 and day 90
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