Varicose Veins
Conditions
Keywords
varicose veins, venous insufficiency, surgery, duplex, recurrence
Brief summary
Duplex imaging is costly and time-consuming, but is used increasingly for preoperative evaluation of varicose veins. Its value in terms of the long-term results of surgery is not clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were compared at 2 months and 2 years after surgery. Routine preoperative duplex examination led to an improvement in results. However two years is a short time, and with a longer follow-up other mechanisms for recurrence may become more important, e.g. neovascularization (new vessel formation) or progression of disease, hence the value of a detailed preoperative diagnosis may be diminished. The aim of this phase of the investigation is to study the results after 8 years, in particular what mechanisms for recurrences were most important.
Interventions
PROCEDUREpreoperative duplex examination
PROCEDUREPreoperative duplex
Sponsors
Capio Research Foundation
Region Stockholm
Uppsala University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients with primary varicose veins
Exclusion criteria
* pure cosmetic complaints * previous venous surgery or sclerotherapy * history of suspect or manifest deep venous thrombosis * active or healed venous ulceration * peripheral arterial disease * previous significant trauma to the leg * general illness * alcohol or drug abuse * unable to understand information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Re-do Surgery | 7 years mean | number of reoperations (legs) in the two treatment arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate | 7 years | number of recurrences in treatment arms but also nature of recurrences |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varicose Vein Surgery With Preoperative Duplex The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail | 148 |
| Varicose Vein Surgery Without Preoperative Duplex The surgeon has planned surgery for varicose veins from a clinical examination only | 145 |
| Total | 293 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 35 | 37 |
Baseline characteristics
| Characteristic | Varicose Vein Surgery With Preoperative Duplex | Varicose Vein Surgery Without Preoperative Duplex | Total |
|---|---|---|---|
| Age Continuous | 56.3 years STANDARD_DEVIATION 10.6 | 52.6 years STANDARD_DEVIATION 12.9 | 54 years STANDARD_DEVIATION 11 |
| Region of Enrollment Sweden | 148 participants | 145 participants | 293 participants |
| Sex: Female, Male Female | 108 Participants | 109 Participants | 217 Participants |
| Sex: Female, Male Male | 40 Participants | 36 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 148 | 0 / 145 |
| serious Total, serious adverse events | 0 / 148 | 0 / 145 |
Outcome results
Primary
Rate of Re-do Surgery
number of reoperations (legs) in the two treatment arms
Time frame: 7 years mean
Population: The number of legs has been analyzed, randomized 166 legs in the duplex group and 177 in the no-duplex group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varicose Vein Surgery With Preoperative Duplex | Rate of Re-do Surgery | 15 legs |
| Varicose Vein Surgery Without Preoperative Duplex | Rate of Re-do Surgery | 38 legs |
Secondary
Recurrence Rate
number of recurrences in treatment arms but also nature of recurrences
Time frame: 7 years
Population: The number of legs with recurrence of varicose veins in the saphenofemoral junction (SFJ)or saphenopopliteal junction (SPJ)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varicose Vein Surgery With Preoperative Duplex | Recurrence Rate | 13 legs |
| Varicose Vein Surgery Without Preoperative Duplex | Recurrence Rate | 46 legs |