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 on post-operative day 14.The secondary objective is to study the…
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 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.
Secondary outcome
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.
Background summary
In developed countries lower extremity venous insufficiency affects up to 15%
of men and 35% of women. Leading to significant reduction in health-related
quality of life (HRQOL) and accounts for 1-2% of the total health care
spending. There is a positive relationship between higher age and obesitas, and
varicosis. 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. The investigators suggest that compression after vein
surgery reduces the risk of hematomas, edema and pain. 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.
Study 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 on post-operative day 14.
The secondary objective is to study the hinder and quality of life for the
patients, post-operative pain and time to full recovery.
Study design
Prospective, single-blinded, randomized, controlled, single center,
intervention study.
Intervention
After randomization, patients will be allocated to either no compressive
therapy or a class II TED stocking for 4 hours.
Study burden and risks
All patients who are randomized to the study may benefit from a shorter
aftercare period or receive standard aftercare.
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
Hoograamstraat 113
Maastricht 6211 BJ
NL
Hoograamstraat 113
Maastricht 6211 BJ
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 (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)
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 | NL46948.096.13 |