to evaluate if 4 hours of pressure bandage has the same effect as current practice (3 days of a Class II TEK stocking). The secondary objective is to study the hinder and quality of life for the patients
ID
Source
Brief title
Condition
- Venous varices
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is edema of the leg, objectified by volume measurements
using a Perometer® (Bösl Medizintechnik, Aachen- Deutschland) at 3 moments:
pre-operative, 3 days and 2 weeks
Secondary outcome
Post-operative pain, postoperative complications, time to full recovery and
quality of life are secondary endpoints. Postoperative pain will be scored by
the patient on a VAS scale from 0-10. The HRQOL will be estimated by the SF-36
questionnaire, which will be asked to fill in at randomization and after 2
weeks. Included will be the question to determine time to full recovery after
the operation. Postoperative complications will be documented
Background summary
In developed countries lower extremity venous insufficiency affects up to 15%
of men and 35% of women [1, 2], leads to significant reduction in
health-related quality of life (HRQOL) and accounts for 1-2% of the total
health care spending. Radiofrequency ablation (RFA) is an accepted treatment
for patients with primary GSV incompetence. However the best aftercare is not
known.
Study objective
to evaluate if 4 hours of pressure bandage has the same effect as current
practice (3 days of a Class II TEK stocking). The secondary objective is to
study the hinder and quality of life for the patients
Study design
prospective, non-blinded, randomized, controlled, single center, intervention
study
Intervention
After randomization patients will be allocated to either pressure bandage for 4
hours or a class II TEK stocking for 3 days
Study burden and risks
All patients who are randomized to the study may benefit from a shorter
aftercare period or receive standard aftercareIn ontwikkelde landen
Henri Dunantstraat 5
6419 PC, Heerlen
NL
Henri Dunantstraat 5
6419 PC, Heerlen
NL
Listed location countries
Age
Inclusion criteria
- patients with primary varicosity of the GSV, between age 18-80 year (C2 * C4 according to CEAP classification)
- unilateral radiofrequency ablation
Exclusion criteria
- ulcus cruris (C6 according to CEAP classification)
- healed ulcus cruris (C5 according to CEAP classification)
- non-compliance to wearing pressure bandage
- bilateral radiofrequency ablation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36341.096.11 |