|- candidate number||17719|
|- NTR Number||NTR4591|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mei-2014|
|- Secondary IDs||13-T-159 |
|- Public Title||Study comparing no compression therapy versus 4 hours of compression therapy after varicose vein surgery|
|- Scientific Title||A randomized controlled trial comparing no compression versus 4 hours of compression therapy with a Thrombo Embolic Deterrent (TED) class II stocking after radiofrequency ablation for primary great saphenous vein incompetence.|
|- ACRONYM||VNUS study|
|- hypothesis||Compression therapy is not necessary after VNUS. Patients receiving no compression therapy after VNUS will have similar outcomes in post-operative pain, oedema, and HRQOL, post-operative complications, time to full recovery. |
|- Healt Condition(s) or Problem(s) studied||Varicose veins|
|- 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||- ulcus cruris (C6 according to CEAP classification)|
- healed ulcus cruris (C5 according to CEAP classification)
- non-compliance to therapy
- bilateral radiofrequency ablation (RFA)
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2014|
|- planned closingdate||1-mei-2015|
|- Target number of participants||104|
|- Interventions||No compression therapy|
4 hours TED class 2 stockings
|- Primary outcome||Pain|
|- Secondary outcome||Oedema, HRQOL, post-operative complications, time to full recovery|
|- Timepoints||- Pre-operative|
- 3 days post-operative
- 2 weeks post-operative
- 3 months post-operative
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. T.A. Sigterman|
|- CONTACT for SCIENTIFIC QUERIES||Drs. T.A. Sigterman|
|- Sponsor/Initiator ||Atrium Medisch Centrum Parkstad|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: In developed countries lower extremity venous insufficiency affects up to 15% of men and 35% of women [1, 2]. Leading to significant reduction in health-related quality of life (HRQOL) and accounts for 1-2% of the total health care spending. Due to aging and increasing incidence and prevalence of obesity the incidence of varicosis is increasing. Radiofrequency ablation (RFA) is a widely accepted treatment for patients with primary great saphenous vein (GSV) incompetence. |
Currently, the usual aftercare consists of compression therapy for several hours up to several weeks. However, evidence to support this practice is based on limited case series describing small patient groups undergoing the old fashioned stripping technique. Today, this intervention is not current practice. To the best of the authors knowledge no randomized controlled trial have been reported to this day comparing no compressive therapy versus any compressive therapy. However, recent studies conducted in the Atrium MC showed that there is no significant difference in the effectiveness of giving compression therapy for 4 hours versus 72 hours concerning pain, leg volume and recovery when RFA is performed. Furthermore, the overall complication rate was significantly less in the 4 hours group, compared to the 72 hours control group. This study is under review in the European Journal of Vascular and Endovascular Surgery at this moment. (Results in addendum A)
Objective: To evaluate whether no utilization of compressive stockings is as effective as wearing a Class II Thrombo Embolic Deterrent (TED) stocking for 4 hours. Primary outcome is leg volume at post-operative day 14. Secondary outcomes are pain and time to full recovery. Pain will be measured by using the standardized Visual Analalogue Scale (VAS) from 1 to 10.
The secondary objective is to study the hinder and quality of life for the patients, subsequently post-operative pain will be assessed.
Study design: Prospective, single-blinded, randomized, controlled, single center, intervention study.
Study population: 104 consecutive patients with primary GSV incompetence and treated by radiofrequency ablation presenting at the outpatient clinic.
Intervention: After randomization, patients will be allocated to either no compressive therapy or a TED class II stocking for 4 hours.
Main study parameters/endpoints: The primary endpoint is edema of the leg, objectified by volume measurements at day 14 post-operative, 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.
Patients will also be asked to give permission to be approached one year after venous surgery has been performed to analyse reccurence rate of venous insufficiency. This will be performed utilizing Duplex-examination performed by vascular laborants of the clinical neurophysiological laboratorium (KNF) in the Atrium MC.
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. 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. Furthermore, patients will be asked to keep a log book of their intake of any analgesic medication. See addendum B.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Possible benefits for the intervention group include:
• patient is less hindered in mobility by absence of a TED stocking to reach full mobility sooner
• less stress and postoperative care after radiofrequency ablation
• more comfort due to not wearing TED stocking
Risks to the intervention group
• possible higher chance for bleeding on the operated leg
• possible higher chance for edema to the operated leg
• possible higher chance for more pain on the operated leg, due to possibly more edema and hematoma
|- Main changes (audit trail)|
|- RECORD||12-mei-2014 - 4-jun-2014|