OBJECTIVES:Transilluminated powered phlebectomy (TriVex) is a new surgical technique that uses tumescent dissection, transillumination, and powered phlebectomy. The purpose of this study was to compare TriVex with conventional varicose vein surgery in terms of pain, cosmesis, recurrence, complications, and operating time. METHODS:One hundred eighty-eight limbs in 141 patients (33 men, 108 women; mean age, 42.5 years) with varicose veins were randomised to conventional (n = 100) or TriVex (n = 88). Exclusion criteria were venous ulceration or deep venous disease. Varicosities were graded with CEAP and clinical assessment (grades 1-3), and were similar in both groups. Randomization was single blinded. Long or short saphenous vein ligation or stripping was performed as indicated with duplex scanning. Operative time was from skin incision to leg bandaging. Phlebectomy was performed with conventional stab avulsions or TriVex. Patients completed assessment forms preoperatively and postoperatively (2, 6, 26, 52 weeks), and this was supplemented with physician clinical evaluation. Pain was assessed with visual analog score. RESULTS: There was a significant difference in the number of incisions for phlebectomy in the two groups (conventional, n = 29; TriVex, n = 5; P <.0001). TriVex was faster in the grade 3 (extensive) group, but this did not reach statistical significance. There was no difference in mean postoperative pain score over 8 days in the two groups (P =.4624). At 2 weeks there was no significant difference between the groups with regard to bruising (P =.77), cellulitis (P =.33), and numbness (P =.33). At 6 weeks there was no significant difference between the groups with regard to nerve injury (P =.97), residual veins (P =.79), cosmetic score (P =.837), and overall satisfaction (P =.878). At 6 and 12 months, there was no significant difference in cosmesis (P =.955, P =.088, respectively) or recurrence (P =.27, P =.11, respectively). CONCLUSIONS:TriVex is a safe and effective method for excision of varicosities and compares well, after a learning curve, with conventional surgery in regard to complications and recurrence. It has the advantage of a trend toward reduced operating time in extensive varicosities, and significantly fewer incisions, although there was no perceived difference in cosmesis during follow-up.
RCT Entities:
OBJECTIVES: Transilluminated powered phlebectomy (TriVex) is a new surgical technique that uses tumescent dissection, transillumination, and powered phlebectomy. The purpose of this study was to compare TriVex with conventional varicose vein surgery in terms of pain, cosmesis, recurrence, complications, and operating time. METHODS: One hundred eighty-eight limbs in 141 patients (33 men, 108 women; mean age, 42.5 years) with varicose veins were randomised to conventional (n = 100) or TriVex (n = 88). Exclusion criteria were venous ulceration or deep venous disease. Varicosities were graded with CEAP and clinical assessment (grades 1-3), and were similar in both groups. Randomization was single blinded. Long or short saphenous vein ligation or stripping was performed as indicated with duplex scanning. Operative time was from skin incision to leg bandaging. Phlebectomy was performed with conventional stab avulsions or TriVex. Patients completed assessment forms preoperatively and postoperatively (2, 6, 26, 52 weeks), and this was supplemented with physician clinical evaluation. Pain was assessed with visual analog score. RESULTS: There was a significant difference in the number of incisions for phlebectomy in the two groups (conventional, n = 29; TriVex, n = 5; P <.0001). TriVex was faster in the grade 3 (extensive) group, but this did not reach statistical significance. There was no difference in mean postoperative pain score over 8 days in the two groups (P =.4624). At 2 weeks there was no significant difference between the groups with regard to bruising (P =.77), cellulitis (P =.33), and numbness (P =.33). At 6 weeks there was no significant difference between the groups with regard to nerve injury (P =.97), residual veins (P =.79), cosmetic score (P =.837), and overall satisfaction (P =.878). At 6 and 12 months, there was no significant difference in cosmesis (P =.955, P =.088, respectively) or recurrence (P =.27, P =.11, respectively). CONCLUSIONS: TriVex is a safe and effective method for excision of varicosities and compares well, after a learning curve, with conventional surgery in regard to complications and recurrence. It has the advantage of a trend toward reduced operating time in extensive varicosities, and significantly fewer incisions, although there was no perceived difference in cosmesis during follow-up.