To compare single ambulatory phlebectomies (SAP) with or without delayed endovenous thermal ablation (EVTA) (after 9 months) with combined thermal ablation and phlebectomies (TAP) (control arm).
ID
Source
Brief title
Condition
- Venous varices
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cost-effectiveness
Secondary outcome
Elimination of reflux in GSV (or AASV), patient reported outcomes (including
symptoms, satisfaction and health related quality of life), direct and indirect
costs, clinical class of the CEAP classification, venous clinical severity
score and predictors of success.
Background summary
It is suggested that reflux of the saphenous trunk may be reversible.
Therefore, treating varicose veins in a more conservative manner by SAP may be
a cost effective strategy.
Study objective
To compare single ambulatory phlebectomies (SAP) with or without delayed
endovenous thermal ablation (EVTA) (after 9 months) with combined thermal
ablation and phlebectomies (TAP) (control arm).
Study design
Multicentre randomised controlled trial
Intervention
SAP (with or without delayed EVTA) or TAP with follow-up at 3, 9, 12, and 60
months
Study burden and risks
in approximately 25% of all treated patients with varicose veins and reflux of
the GSV or AASV, ablation of the trunk can be avoided resulting in fewer
complications and costs. However in 1/3 of these patients the SAP procedure
will not be sufficient and patients will need a second intervention with EVTA.
Burgemeester s' Jacobplein 51 Burgemeester s' Jacobplein 51
3000 CA Rotterdam
NL
Burgemeester s' Jacobplein 51 Burgemeester s' Jacobplein 51
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
patients with primary incompetent GSV and tributaries and patients with primary incompetent AASV and tributaries.
Exclusion criteria
previous treatment of ipsilateral GSV trunk or tributary (or in case of AASV, previous treatment of ipsilateral AASV trunk or tributary) deep venous thrombosis and agenesis, post-thrombotic syndrome of the obstructive type, pregnancy and arterial disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL49701.078.14 |
| OMON | NL-OMON24499 |