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Haemodynamic CHIVA correction surgery versus compression for primary venous ulcers: first year results
Zamboni P, Cisno C, Marchetti F, Mazza P, Fogato L, Carandina S, de Palma M, Liboni A
Phlebology 2004 Mar;19(1):28-34
clinical trial
3/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To compare two different treatments for primary venous ulcers: a minimally invasive surgical technique for the haemodynamic correction of reflux, versus a traditional compression treatment. METHOD: From a cohort of 87 lower extremities affected by the first episode of venous ulcers, 45 mobile patients affected by primary chronic venous insufficiency were randomized to receive either the haemodynamic correction procedure (CHIVA) or compression treatment. RESULTS: Mean follow up lasted one year. The rate of healing in the surgical group was 100% in a mean time of 29 days with a velocity of 2.86 mm2/day, and in the conservative group the rate was 96% in 61 days, with a velocity of 1.66 mm2/day (p < 0.02). All air plethysmographic parameters, with the exception of ejection fraction, significantly improved at six months in the surgical group. Finally, quality of life significantly improved in both groups, but in the surgical group the following domains were significantly different compared with the compression group: RP, role limitations due to physical problems; VT, energy/vitality; SF, social functioning; RE, role limitations due to emotional problems; and MH, mental health. CONCLUSIONS: Surgical haemodynamic correction of reflux has been demonstrated to improve venous function, time to ulcer healing and quality of life when compared with compression treatment.

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