A randomized comparative single center study of the treatment of the insufficient greater saphenous vein: crossectomy with short strip vs Ultrasound sclerocompression therapy (ESCT) vs endovasculair laser (EVLT). The Magna trial.

A randomized comparative single center study of the treatment of the insufficient greater saphenous vein: crossectomy with short strip vs Ultrasound sclerocompression therapy (ESCT) vs endovasculair laser (EVLT). The Magna trial. - The Magna trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30306

Enrollment

240

Registered

2006-09-27

Start date

2007-03-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic venous insufficiency

Interventions

1. Crossectomy with short strip 2. Ultrasound guided sclerocompression therapy (ESCT) 3. Endovasculair laser therapy (EVLT)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: >18 years old Objective GSV insufficiency (Ultrasound reflux >0.5 sec with diameter >0.49) Non treated GSV varicosis CEAP classification (C2, As2) Informed consent

Exclusion criteria

Exclusion criteria: Acute deep and superficial venous thrombosis Deep venous insufficiency Agenesia deep venous system Vasculair malformations / syndromes Post thrombotic syndrome pregnancy heart failure contra-indication for surgery Immobility Allergic reactions (lidocaine and/or polidocanol) Arterial insufficiency Use of anti-coagulation drugs

Design outcomes

Primary

Measure	Time frame
Primairy outcomes: 1. Ultrasound: a. absence of GSV and/or absence of reflux of the GSV >0.5 sec at the crosse, mid upper leg and just distaal of the knee b. Degree of neovascularization (grade 1 to 3) 2. Clinical characteristics: a. using the CEAP classification 3. Additional treatments on the included GSV a. number of additional ESCT treatments after initial therapy	—

Secondary

Measure	Time frame
Secondary: 1. Patient reported outcomes: a. Reduction of chronic venous insufficiency symptoms on VAS (0-100) b. Global treatrment satisfaction on VAS (0-100) c. Health related quality of life (EQ-5D and CIVIQ) d Adjusted Treatment Medication Satisfaction Questionnaire (TMSQ) Tertiary: 1. Adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)