NCT00621062

Prospective Randomized Trial Comparing the New Endovenous Procedures Versus Conventional Surgery for Varicose Veins Due to Great Saphenous Vein Incompetence

Randomized Prospective Trial of Varicose Vein Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Through a prospective RCT evaluate and compare the three new endovenous methods for great saphenous vein ablation (Radiofrequency, endovenous laser and foam sclerotherapy) versus high ligation and stripping. Procedure (proof-of-concept) and patient related (clinical outcome) factors will be studied.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2008-02-22
• Last updated: 2014-02-03

Locations

1 site across 1 country: Sweden