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| Name | Class |
|---|---|
| Capio Research Foundation | OTHER |
| Region Stockholm | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varicose vein surgery with preop duplex | Active Comparator | 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 |
|
| varicose vein surgery no preop duplex | No Intervention | The surgeon has planned surgery for varicose veins from a clinical examination only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoperative duplex examination | Procedure |
| ||
| Preoperative duplex |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Re-do Surgery | number of reoperations (legs) in the two treatment arms | 7 years mean |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rate | number of recurrences in treatment arms but also nature of recurrences | 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capio StGörans Gospital | Stockholm | SE-11821 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16378147 | Background | Blomgren L, Johansson G, Bergqvist D. Quality of life after surgery for varicose veins and the impact of preoperative duplex: results based on a randomized trial. Ann Vasc Surg. 2006 Jan;20(1):30-4. doi: 10.1007/s10016-005-9285-z. | |
| 16102633 | Background | Blomgren L, Johansson G, Dahlberg-Akerman A, Thermaenius P, Bergqvist D. Changes in superficial and perforating vein reflux after varicose vein surgery. J Vasc Surg. 2005 Aug;42(2):315-20. doi: 10.1016/j.jvs.2005.03.043. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Varicose Vein Surgery Without Preoperative Duplex | The surgeon has planned surgery for varicose veins from a clinical examination only |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Varicose Vein Surgery Without Preoperative Duplex |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Re-do Surgery | number of reoperations (legs) in the two treatment arms | The number of legs has been analyzed, randomized 166 legs in the duplex group and 177 in the no-duplex group | Posted | Number | legs | 7 years mean |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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The rate of hand-held Doppler device use was not known and may have influenced the results, however even now many Swedish surgeons plan varicose vein surgery clinical tests only
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lena Blomgren MD PhD | Uppsala UH | +46851774173 | lena.blomgren@karolinska.se |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014689 | Venous Insufficiency |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| Procedure |
|
| 15810046 | Result | Blomgren L, Johansson G, Bergqvist D. Randomized clinical trial of routine preoperative duplex imaging before varicose vein surgery. Br J Surg. 2005 Jun;92(6):688-94. doi: 10.1002/bjs.4983. |
| 21618499 | Result | Blomgren L, Johansson G, Emanuelsson L, Dahlberg-Akerman A, Thermaenius P, Bergqvist D. Late follow-up of a randomized trial of routine duplex imaging before varicose vein surgery. Br J Surg. 2011 Aug;98(8):1112-6. doi: 10.1002/bjs.7579. Epub 2011 May 27. |
| 31992538 | Derived | Blomgren L. Residual incompetent tributaries after varicose vein surgery increased the need for reintervention after 8 years. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):378-382.e1. doi: 10.1016/j.jvsv.2019.11.012. Epub 2020 Jan 25. |
The surgeon has planned surgery for varicose veins from a clinical examination only |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Recurrence Rate | number of recurrences in treatment arms but also nature of recurrences | The number of legs with recurrence of varicose veins in the saphenofemoral junction (SFJ)or saphenopopliteal junction (SPJ) | Posted | Number | legs | 7 years | legs | Participants |
|
|
|
| 0 |
| 148 |
| 0 |
| 148 |
| EG001 | Varicose Vein Surgery Without Preoperative Duplex | The surgeon has planned surgery for varicose veins from a clinical examination only | 0 | 145 | 0 | 145 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |