Effects of compressive bandages following stripping of greater saphenous vein (GSV) (EFFecten van COMpressief DRukverband na Varices OPeratie)

Completed

• Conditions: Venous insufficiency; Circulatory System; Venous insufficiency (chronic)(peripheral)

• Registration Number: ISRCTN22302839
• Lead Sponsor: Atrium Medical Centre (Atrium Medisch Centrum) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

1. CEAP classification C5-C6
2. Non-compliance with postoperative compressive therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Post-operative pain will be scored by the patient on a standardized Visual Analogue Scale (VAS) from 1 to 10. <br>2. Postoperative complications such as subcutaneous hematoma formation, thrombophlebitis and postoperative swelling will be documented. <br>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.