Venous insufficiency Circulatory System Venous insufficiency (chronic)(peripheral)
Conditions
Interventions
Randomization of subjects with the aid of a computer performed randomisation list generated. Randomization works with a block size of 8 subjects to promote equal distribution of numbers of patients on
Sponsors
Atrium Medical Centre (Atrium Medisch Centrum) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary insufficiency of GSV (CEAP classification; C2 en C3) 2. Unilateral crossectomy and strip of GSV 3. Bilateral crossectomy and strip of GSV
Exclusion criteria
Exclusion criteria: 1. CEAP classification C5-C6 2. Non-compliance with postoperative compressive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is edema of the leg, objectified by volume measurements at day 14 post-operative, performed by the investigator. 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Post-operative pain will be scored by the patient on a standardized Visual Analogue Scale (VAS) from 1 to 10. 2. Postoperative complications such as subcutaneous hematoma formation, thrombophlebitis and postoperative swelling will be documented. 3. Time to full recovery 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. | — |
Countries
Netherlands
Outcome results
None listed