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Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.
The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative treatment | Other | vein stripping |
|
| Laser ablation | Other | Ultrasound guided laser ablation |
|
| Foam sclerotherapy | Other | Ultrasound guided foam sclerotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operative treatment | Procedure | In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recanalization or reflux of the treated venous trunk | Results will be verified by Duplex scanning | at 1 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom relief | Symptoms will be evaluated by using CEAP-classification and degree of disability | at 1 and 12 months |
| Complications related to procedure | At 1 month follow-up immediate complications will be recorded. At 12 months follow-up appearance of late complications and pain and incapacity for work due to the procedure will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarit Venermo, MD,PhD | Department of Vascular Surgery, Helsinki University Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Surgery, Helsinki University Central Hospital | Helsinki | HUS | 00029 | Finland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29652086 | Derived | Vahaaho S, Halmesmaki K, Alback A, Saarinen E, Venermo M. Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins. Br J Surg. 2018 May;105(6):686-691. doi: 10.1002/bjs.10757. |
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| D014648 | Varicose Veins |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D011468 | Prostatectomy |
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|
| Laser ablation | Procedure | In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. |
|
|
| Foam sclerotherapy | Procedure | Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. |
|
|
| at 1 and 12 months |
| Quality of life | Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life) | at 1 and 12 months |
| Department of Vascular Surgery, Tampere University Hospital |
| Tampere |
| 33521 |
| Finland |
| D013521 |
| Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |