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Parva II Trial: Randomized unicentre trial of re-crossectomy vs (repeated) ultrasound guided foam sclerotherapy of recurrence after crossectomy of the small saphenous vein

Parva II Trial: Randomized unicentre trial of re-crossectomy vs (repeated) ultrasound guided foam sclerotherapy of recurrence after crossectomy of the small saphenous vein - SSV II Trial

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33660
Enrollment
120
Registered
2009-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

recurrence of varicose veins

Interventions

crossectomy vs ultrasound guided sclerofoam therapy

Sponsors

Amphia Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Objective insufficiency (> 0.5 seconds on ultrasound examination) of the SSV after crossectomy (with or without stripping) with visible neovascularisation at the sapheno-popliteal junction

Exclusion criteria

Exclusion criteria: thrombosis (superficial or deep) or thrombotic disease

Design outcomes

Primary

MeasureTime frame
Anatomical and/or hemodynamic success on ultrasound examination. Success is defined by the absence of reflux >0.5 seconds (with or without sclerus) in the SSV at 2 sites: the saphenopopliteal junction and halfway the calf (after 3, 12 months and 5 years).

Secondary

MeasureTime frame
1. Number of additional UGFS treatments after the randomized treatment. 2. Number and type of additional treatments for varicosities in study limb. 3. Patient's satisfaction about the treatment (10-points scale, from very unsatisfied to very content) after 3 and 12 months. 4. Quality of life, measured with the SF-36 test on t=0, after 2 weeks and after 3 months. 5. Patient's reported complications (pain, hematoma, infection, paresthesia) and doctor's reported complications after 2 weeks (superficial and deep thrombosis, hyperpigmentation).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)