Prospective Randomized Trial Comparing the New Endovenous Procedures Versus Conventional Surgery for Varicose Veins Due to Great Saphenous Vein Incompetence (RAFPELS)
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|ClinicalTrials.gov Identifier: NCT00621062|
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : February 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Varicose Veins||Procedure: High Ligation of the GSV Procedure: Endovenous Laser Ablation Procedure: Radiofrequency ablation Procedure: Foam Sclerotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized Prospective Trial of Varicose Vein Surgery|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
|Active Comparator: High Ligation of the GSV||
Procedure: High Ligation of the GSV
Performed in local or general anesthesia in accordance to clinical praxis and the patients own preference. After high ligation the GSV is stripped from the groin to the most distant insufficient part or just under the knee joint.All proximal branches are ligated. Including the superficial epigastric vein. The stripping instrument can be inserted in either cranial or caudal direction but all veins are stripped in the cranio-caudal direction.
|Active Comparator: Endovenous Laser Ablation||
Procedure: Endovenous Laser Ablation
Laser ablation is performed in tumescence anesthesia which is performed with a 150-200 ml (sometimes more is required, up to 400ml in patients with a poorly formed saphenous sheath) solution of lidocaine with adrenaline supplement. General sedation can be administrated as a supplement (with intravenous Propofol or Dormicum when needed). Laser is performed under duplex guidance and the catheter is inserted percutaneously into the GSV at knee level and parked distant to the saphenofemoral junction (SFJ) just distal to the superficial epigastric vein. Laser ablation is performed down to the most distal insufficient part of GSV or just below the knee joint. We use an effect of 14 Watt administration of 70-80 J / cm at a continuous mode at a speed of 1cm/5sec.
|Active Comparator: Radiofrequency ablation||
Procedure: Radiofrequency ablation
RF ablation is performed in tumescence anesthesia which is performed with a 150-200 ml solution (same as above) of lidocaine with adrenaline supplement. General sedation can be administrated as a supplement (with intravenous Propofol or Dormicum when needed). RF is performed under duplex guidance and the Closure-FAST catheter is inserted percutaneously into the GSV at the knee level and parked distant to the SFJ just distal to the superficial epigastric vein. Probe size and length used for RF is chosen in accordance to the manufacturer's recommendation and with a probe temperature of 120 degrees C. RF closure is performed down to the most distal insufficient part of GSV or just under the knee joint.
|Active Comparator: Foam Sclerotherapy||
Procedure: Foam Sclerotherapy
Sclerosant foam consists of 2ml 3% aethoxysclerol mixed with 8ml air (Tessari method). A maximum of 10 ml is injected. Access to the vein for the sclerosant is gained by a duplex guided puncture or a mini incision mid-thigh or just above the knee and the amount of sclerosant foam used is 2,5-10 ml. Duplex is used prior to the operation in order to mark the vein and during the operation in order to control the extent of the sclerofoam. Duplex validates that foam is deposed to the whole length of the GSV. Blood from the veins is drained by means of elevation prior to the deposition of the sclerofoam. The leg is then bandaged with elastic bandage.
- Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation. [ Time Frame: 3 years ]
- Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621062
|Department of Vascular Surgery; Central Hospital of Västerås|
|Västerås, Sweden, 72189|
|Principal Investigator:||Anders Hellberg, MD, PhD||Dept. of Vascular Surgery, Central Hospital of Västerås|
|Principal Investigator:||Adam Bersztel, MD, PhD||Dept. of Vascular Surgery, Central Hospital of Västerås|
|Study Chair:||Jerszy Leppert, Professor||Västerås Centrum for Clinical Research, University of Uppsala|
|Principal Investigator:||Achilleas Karkamanis, MD||Dept. of Vascular Surgery, Central Hospital of Västerås|