Comparing two classes of compression hosiery after varicose vein treatment
First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy: Randomized Controlled Trial (FISCHER)
This study is testing whether first-class compression stockings are easier and more comfortable for people recovering from varicose vein treatment compared to second-class stockings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Moscow City Hospital named after A.K. Eramishantsev Government |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06913764 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of first-class versus second-class compression therapy in patients undergoing endovenous laser ablation (EVLA) for varicose veins. The hypothesis is that first-class compression stockings will improve patient adherence due to easier application and reduced discomfort during the postoperative period. Participants will be monitored for two weeks following their EVLA procedure, which includes sclerotherapy and ambulatory phlebectomy. The study seeks to address the challenges of patient compliance with compression therapy, which is crucial for optimal recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with varicose veins in the great saphenous vein and its tributaries who are scheduled for EVLA.
Not a fit: Patients with contraindications for prolonged compression therapy or those with severe chronic venous disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient comfort and adherence to compression therapy, leading to improved recovery outcomes after varicose vein treatment.
How similar studies have performed: Previous studies have shown the benefits of compression therapy in postoperative recovery, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Varicose veins of the lower extremities (CEAP classification C2-C5) * Varicose disease in the great saphenous vein (GSV) and its tributaries * Planned endovenous laser ablation of the GSV trunk with concomitant combined sclerotherapy and phlebectomy of tributaries * Technical success of intervention (complete ablation of the GSV) * Signed informed consent for study participation Exclusion Criteria: * Primary reflux outside the GSV trunk * History of or acute deep vein thrombosis * Deep vein insufficiency * GSV recanalization post-intervention * Clinical class C6 of chronic venous disease (CVD) according to CEAP classification * Contraindications or limitations for prolonged compression therapy, including but not limited to chronic arterial diseases of the lower extremities (any severity), skin diseases * Pathological conditions of lower limbs causing non-venous pain * Use of vasoactive medications within 1 month before/after surgery * Refusal to participate in the study
Where this trial is running
Moscow
- Moscow City Hospital named after A.K. Eramishantsev — Moscow, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Boris Danelian, MD — Moscow City Hospital named after A.K. Eramishantsev
- Study coordinator: Hovsep P. Manjikian, MD
- Email: manjikyan@gmail.com
- Phone: +79261076056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.