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| Name | Class |
|---|---|
| University of Hull | OTHER |
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Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL).
Surgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury.
Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years.
26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.
Newer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins.
Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out.
The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Active Comparator | Patients undergo Surgery under a general anaesthetic. |
|
| EVLT | Experimental | Patients undergo EVLT under a local anaesthetic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Generic Quality of Life - Short Form-36 | 1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Specific Quality of Life - Aberdeen Varicose Vein Questionnaire | 1 Week, 6 Weeks, 3 Months, 1 Year, 2 Years | |
| Generic quality of life - EuroQol | 1 week, 6 weeks, 3 months, 1 year, 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian C Chetter, MBChB | University of Hull | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull Royal Infirmary | Hull | East Yorkshire | HU3 2JZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23160149 | Derived | Samuel N, Carradice D, Wallace T, Mekako A, Hatfield J, Chetter I. Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. Ann Surg. 2013 Mar;257(3):419-26. doi: 10.1097/SLA.0b013e318275f4e4. | |
| 20510634 | Derived | Carradice D, Mazari FA, Mekako A, Hatfield J, Allgar V, Chetter IC. Energy delivery during 810 nm endovenous laser ablation of varicose veins and post-procedural morbidity. Eur J Vasc Endovasc Surg. 2010 Sep;40(3):393-8. doi: 10.1016/j.ejvs.2010.04.010. Epub 2010 May 26. |
| Label | URL |
|---|---|
| Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins | View source |
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| EVLT | Procedure | EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required. |
|
|
| Venous Clinical Severity Score | 3 months, 1 year, 2 years |
| Visual analogue pain scores | 1 week |
| Return to work and normal functioning | 1 week, 6 weeks |
| Would undergo EVLT again if necessary | 1 week, 6 weeks, 3 months, 1 year, 2 years |
| Complication rates | 1 week, 6 weeks, 3 months, 1 year, 2 years |
| Duplex assessment | 1 week, 6 weeks, 3 months, 1 year, 2 years |
| Cost Effectiveness | 2 years |
| A randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. | View source |