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A comparison of the effectiveness of treating those with and without the complications of superficial venous insufficiency . OBJECTIVE To test the hypothesis that patients with soft tissue changes related to superficial venous insufficiency ( SVI ) have greater benefits from treatment than those with only symptomatic varicose veins . BACKGROUND A commonly held view is that SVI is only a minor ailment , yet randomized clinical trials ( RCTs ) show that treatment improves quality of life ( QoL ) and is cost-effective . In an effort to curb the treatment costs of this common disorder , rationing is applied in many health care systems , often limiting the reimbursement of treatment to those with soft tissue changes . METHODS This cohort study draws its data from an interventional RCT . After informed consent , consecutive patients with symptomatic unilateral SVI were randomized to receive surgical ligation and stripping or endovenous laser ablation . This analysis differentially studies the outcomes of patients with simple varicose veins ( C2 : n = 191 ) and soft tissue complications ( C3-4 : n = 76 ) . Effectiveness outcomes measured up to 1 year included the following : Qol [ short form 36 ( SF36 ) , EuroQol , and the Aberdeen Varicose Veins Questionnaire ] , clinical recurrence , and the need for secondary procedures . Multivariable regression analysis was used to control for potential confounding factors . RESULTS Both groups saw significant improvements in QoL . All improvements were equal between groups apart from the SF36 domain of Bodily Pain , where C2 saw an improvement of 12.8 [ 95 % confidence interval ( CI ) : 4.8-20.8 ] points over C3-4 participants ( P = 0.002 ) , who also suffered more recurrence [ odds ratio ( OR ) = 2.7 , 95 % CI : 1.2-6.1 , P = 0.022 ] and required more secondary procedures ( OR = 4.4 , 95 % CI : 1.2-16.3 , P = 0.028 ) . CONCLUSIONS This study suggests that rationing by clinical severity contradicts the evidence . Delaying treatment until the development of skin damage leads to a degree of irreversible morbidity and greater recurrence . TRIAL REGISTRATION NCT00759434 Clinicaltrials.gov .
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Intervention_Physical
interventional RCT .
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Intervention_Surgical
receive surgical ligation
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Intervention_Physical
stripping or endovenous laser ablation
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Outcome_Physical
superficial venous insufficiency
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Outcome_Other
quality of life ( QoL )
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Outcome_Physical
surgical ligation and stripping or endovenous laser ablation .
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Outcome_Physical
Qol [ short form 36 ( SF36 ) , EuroQol , and the Aberdeen Varicose Veins Questionnaire ] , clinical recurrence
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Outcome_Other
QoL .
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Outcome_Pain
Bodily