A randomized controlled trial comparing no compression therapy versus 4 hours of compressive therapy with a TED class II stocking after radiofrequency ablation for primary great saphenous vein incompetence

A randomized controlled trial comparing no compression therapy versus 4 hours of compressive therapy with a TED class II stocking after radiofrequency ablation for primary great saphenous vein incompetence - RCT comparing no compression therapy with 4 hours TED class II stocking

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40253

Enrollment

104

Registered

2014-03-14

Start date

2015-01-23

Completion date

Unknown

Last updated

2024-12-02

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

Conditions

Varicose veins venous insufficiency

Interventions

After randomization, patients will be allocated to either no compressive therapy or a class II TED stocking for 4 hours.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with primary varicosity of the GSV, between age 18-80 year (C2 - C4 according to CEAP classification) - Unilateral radiofrequency ablation (RFA)

Exclusion criteria

Exclusion criteria: - Ulcus cruris (C6 according to CEAP classification) - Healed ulcus cruris (C5 according to CEAP classification) - Non-compliance to therapy - Bilateral radiofrequency ablation (RFA)

Design outcomes

Primary

Measure	Time frame
The primary endpoint is edema of the leg, objectified by volume measurements on post-operative day 14, performed by the investigator (TA Sigterman or HG Rensma). A Perometer® (Bösl Medizintechnik, Aachen- Deutschland) will be used. This leg volume measurement will be performed on three standardized points on the leg: 10 cm above the upper edge of the patella, at the tuberosity of the tibia and 5 cm below the tuberosity of the tibia.	—

Measure

Time frame

The primary endpoint is edema of the leg, objectified by volume measurements on post-operative day 14, performed by the investigator (TA Sigterman or HG Rensma). A Perometer® (Bösl Medizintechnik, Aachen- Deutschland) will be used. This leg volume measurement will be performed on three standardized points on the leg: 10 cm above the upper edge of the patella, at the tuberosity of the tibia and 5 cm below the tuberosity of the tibia.

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Secondary

Measure	Time frame
Time to full recovery, post-operative pain and quality of life are secondary endpoints. The HRQOL will be estimated by the SF-36 questionnaire, which will be asked to fill in at randomization and after 2 weeks. At this point the patient will also be asked to determine the time in days to full recovery after the surgery. Post-operative pain will be scored by the patient on a standardized Visual Analogue Scale (VAS) from 1 to 10. Postoperative complications such as subcutaneous hematoma formation, thrombophlebitis and postoperative swelling will be documented.	—

Measure

Time frame

Time to full recovery, post-operative pain and quality of life are secondary endpoints. The HRQOL will be estimated by the SF-36 questionnaire, which will be asked to fill in at randomization and after 2 weeks. At this point the patient will also be asked to determine the time in days to full recovery after the surgery. Post-operative pain will be scored by the patient on a standardized Visual Analogue Scale (VAS) from 1 to 10. Postoperative complications such as subcutaneous hematoma formation, thrombophlebitis and postoperative swelling will be documented.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)