Effect of Perioperative Calcium Dobesilate on Postprocedural Pain, Symptom Relief, and Quality of Life After Radiofrequency Ablation for Great Saphenous Vein Insufficiency: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Symptomatic primary varicose veins (CEAP classification C2-C4)
- •Great saphenous vein insufficiency confirmed by duplex ultrasound (reflux >0.5 seconds)
- •Great saphenous vein diameter 5-12 mm
- •Scheduled for radiofrequency ablation
- •Able to provide written informed consent
排除标准
- •History of deep vein thrombosis
- •Peripheral arterial disease (ABI <0.9)
- •Active venous ulcer (CEAP C6)
- •Pregnancy or breastfeeding
- •Severe renal or hepatic insufficiency
- •Known allergy to calcium dobesilate
- •Use of venoactive drugs within the past 4 weeks
- •Current anticoagulant therapy
- •Previous venous intervention on the same limb
- •Bilateral disease requiring simultaneous treatment
- •Inability to comply with follow-up schedule
研究组 & 干预措施
Control Group
Participants receive standard care only (RFA plus compression stockings) without calcium dobesilate.
Calcium Dobesilate Group
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).
干预措施: calcium dobesilate (Drug)
结局指标
主要结局
Postoperative Pain Score (VAS)
时间窗: Postoperative day 7
Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain)
次要结局
- Postoperative Pain Score at Day 14 and Day 30(Postoperative day 14 and day 30)
- Venous Clinical Severity Score (VCSS)(Baseline, day 30, and day 90)
- Quality of Life (CIVIQ-20)(Baseline, day 14, day 30, and day 90)
- Ecchymosis Score(Postoperative day 1, day 7, and day 14)
- Time to Return to Normal Activities(Up to 30 days postoperatively)
- Postoperative Paresthesia Incidence(Postoperative day 7, day 30, and day 90)
- Endovenous Heat-Induced Thrombosis (EHIT) Incidence(Postoperative day 7)
- Great Saphenous Vein Occlusion Rate(Postoperative day 30 and day 90)
研究者
Oguz Arslanturk
Assistant Professor, Department of Cardiovascular Surgery
Bulent Ecevit University