NCT06913764

First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy

First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy: Randomized Controlled Trial (FISCHER)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Moscow City Hospital named after A.K. Eramishantsev · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of fist class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.

Detailed description

In recent decades, significant advancements have emerged in varicose vein treatment. Endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) have become the leading techniques for eliminating trunk reflux, while microfoam sclerotherapy and ambulatory phlebectomy are most commonly used for treating tributaries. Post-intervention, patients typically receive recommendations to wear second-class compression stockings to reduce postoperative pain, ecchymosis, and hematomas. However, the optimal duration, regimen, and compression class remain poorly defined. Meanwhile, a growing surgical community advocates for eliminating compression therapy during the postoperative period altogether, citing low patient compliance rates (15-74%). The primary factors driving non-compliance include discomfort while wearing hosiery and difficulties with donning and doffing, suggesting compression hosiery characteristics may significantly impact adherence. Recent meta-analyses support compression therapy's benefits, demonstrating reduced postoperative pain levels and faster return to normal activities among patients using postoperative compression. Additionally, both national and international clinical guidelines recommend compression therapy for at least one week following thermal ablations. Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of first class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.

Conditions

• Varicose Veins
• Chronic Venous Disorder
• Chronic Venous Insufficiency (CVI)
• Venous Reflux
• Great Saphenous Vein (GSV) With Venous Reflux Disease

Interventions

Type	Name	Description
DEVICE	class I compression stockings of the RAL-GZ 387 standard: 1 month using	Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) above-knee graduated compression stockings
DEVICE	class II compression stockings of the RAL-GZ 387 standard: 1 month using	Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings

Timeline

• Start date: 2025-04-07
• Primary completion: 2025-07-01
• Completion: 2025-07-02
• First posted: 2025-04-06
• Last updated: 2025-07-08

Locations

1 site across 1 country: Russia