Endovenous laser ablation versus mechano-chemical endovenous ablation in the treatment of great saphenous incompetence: a multicentric, randomized controlled trial

Phase 4

Completed

Conditions: 10057165
varicose veins
10003184

Registration Number: NL-OMON36499

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 224

Inclusion Criteria

1. Primary great saphenous incompetence
2. C2-C4 varicose veins
3. Ultrasound criteria have to be sufficient for endovenous therapy: diameter of the great saphenous vein > 3mm and < 12mm, not tortuous
4. Signed informed consent
5. Patient willing for follow-up
6. Age > 18 years and < 80 years

Exclusion Criteria

1. Patient not capable for informed consent
2. Pregnancy and lactation
3. Surgical or endovenous therapy for ipsilateral varicose vein incompetence in history
4. Deep venous trombosis in treated leg
5. Use of oral anticoagulantia
6. Contraindications or allergy for sclerosant
7. Immobilisation
8. Coagulation disorders or increased risk of tromboembolic complications
9. Peripheral arterial disease, Fontaine 3-4
10. Severe renal failure
11. Liver insufficiency
12. Other treatment modality is more appropriate for varicose vein treatment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters:<br /><br>- Technical success (occlussion percentage, demonstrated by duplex)<br /><br>- Clinical success (CEAP, VCSS)<br /><br>- Peroperative pain (VAS score)<br /><br>- Postoperative pain for 2 weeks (VAS score, amount of analgesia used)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters:<br /><br>- Postoperative complications<br /><br>- Disease specific quality of life (AVVQ, SF-36)<br /><br>- Time from treatment to resumption of normal activities<br /><br>- Procedural lenght<br /><br>- Costs</p><br>