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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Participants receive standard care only (RFA plus compression stockings) without calcium dobesilate. | |
| Calcium Dobesilate Group | Experimental | Participants receive calcium dobesilate 500 mg orally twice daily, starting 7 days before RFA and continuing for 30 days after the procedure, in addition to standard care (RFA plus compression stockings). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcium dobesilate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score (VAS) | Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain) | Postoperative day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score at Day 14 and Day 30 | Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 to 10 | Postoperative day 14 and day 30 |
| Venous Clinical Severity Score (VCSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oguz Arslanturk, MD | Contact | +905395613887 | oguz.arslanturk@beun.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Oguz Arslanturk, MD | Zonguldak Bulent Ecevit University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zonguldak Bulent Ecevit University Hospital, Department of Cardiovascular Surgery | Kozlu | Zonguldak Province | 67600 | Turkey (Türkiye) |
Individual participant data will not be shared due to local data protection regulations and limited resources for data anonymization and management.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Patients will be randomized 1:1 to intervention (calcium dobesilate) or control (standard care) group.
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Clinical assessment of venous disease severity using standardized VCSS scoring system (0-30 points)
| Baseline, day 30, and day 90 |
| Quality of Life (CIVIQ-20) | Disease-specific quality of life measured using Chronic Venous Insufficiency Questionnaire (CIVIQ-20) | 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) | 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 | 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) | 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) | Postoperative day 7 |
| Great Saphenous Vein Occlusion Rate | Complete occlusion of treated great saphenous vein confirmed by duplex ultrasound (absence of flow and compressibility) | Postoperative day 30 and day 90 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |