Toni Pihlaja1, Pekka Romsi2, Pasi Ohtonen3, Janne Jounila4, Matti Pokela2. 1. Department of Vascular Surgery, Oulu University Hospital, Finland; Medical Research Centre Oulu, University of Oulu, Oulu, Finland. Electronic address: toni.pihlaja@ppshp.fi. 2. Department of Vascular Surgery, Oulu University Hospital, Finland. 3. Medical Research Centre Oulu, University of Oulu, Oulu, Finland; Division of Operative Care, Oulu University Hospital, Oulu, Finland. 4. Department of Surgery, Raahe Regional Hospital, Finland.
Abstract
OBJECTIVE: To compare post-operative compression with no compression, after radiofrequency endothermal ablation (RFA) of a truncal varicose vein and concomitant foam sclerotherapy of the tributaries. METHODS: This prospective randomised controlled, non-inferiority trial recruited patients from two centres in Northern Ostrobothnia, Finland. Patients with clinical class C2-C4 chronic venous disease were randomised to receive no compression after the operation, or to receive compression stockings continuously for two days, and then, during the daytime for five days. In follow up visits, additional foam sclerotherapy was performed for symptoms of distal incompetence. Patients were followed up for six months. The primary outcome was occlusion of the RFA treated truncal vein at six months. Secondary outcomes were return to full activity within 14 days, Aberdeen Varicose Vein Questionnaire (AVVQ) score, post-operative pain, need for painkillers, and postprocedural complications. RESULTS:Of 177 included patients, 90 were allocated to post-operative compression and 87 to no compression. At six months, both groups showed 100% occlusion rates in RFA treated truncal veins (95% confidence interval -0.043-0.042). Within 14 days of treatment, full physical activity was achieved by 87% of the compression group and 81% of the no compression group, (p = .29). At six months, the AVVQ scores were comparable and significantly improved in both groups, compared with baseline. Pain scores were comparable between groups, in day to day analyses, and they were significantly lower in both groups on day 10, compared with pre-operative pain caused by varicose veins. On average, post-operative pain medication was used for 2.3 days and for 2.8 days in the compression and no compression groups, respectively (p = .28). Complications throughout the six month follow up were comparable between groups, although skin rash/blisters occurred more often in the compression group (p = .01). CONCLUSION: After treating C2-C4 varicose veins with RFA and concomitant foam sclerotherapy, no post-operative compression was non-inferior to post-operative compression, in terms of safety and efficacy. ClinicalTrials.gov Identifier: NCT02890563.
RCT Entities:
OBJECTIVE: To compare post-operative compression with no compression, after radiofrequency endothermal ablation (RFA) of a truncal varicose vein and concomitant foam sclerotherapy of the tributaries. METHODS: This prospective randomised controlled, non-inferiority trial recruited patients from two centres in Northern Ostrobothnia, Finland. Patients with clinical class C2-C4 chronic venous disease were randomised to receive no compression after the operation, or to receive compression stockings continuously for two days, and then, during the daytime for five days. In follow up visits, additional foam sclerotherapy was performed for symptoms of distal incompetence. Patients were followed up for six months. The primary outcome was occlusion of the RFA treated truncal vein at six months. Secondary outcomes were return to full activity within 14 days, Aberdeen Varicose Vein Questionnaire (AVVQ) score, post-operative pain, need for painkillers, and postprocedural complications. RESULTS: Of 177 included patients, 90 were allocated to post-operative compression and 87 to no compression. At six months, both groups showed 100% occlusion rates in RFA treated truncal veins (95% confidence interval -0.043-0.042). Within 14 days of treatment, full physical activity was achieved by 87% of the compression group and 81% of the no compression group, (p = .29). At six months, the AVVQ scores were comparable and significantly improved in both groups, compared with baseline. Pain scores were comparable between groups, in day to day analyses, and they were significantly lower in both groups on day 10, compared with pre-operative pain caused by varicose veins. On average, post-operative pain medication was used for 2.3 days and for 2.8 days in the compression and no compression groups, respectively (p = .28). Complications throughout the six month follow up were comparable between groups, although skin rash/blisters occurred more often in the compression group (p = .01). CONCLUSION: After treating C2-C4 varicose veins with RFA and concomitant foam sclerotherapy, no post-operative compression was non-inferior to post-operative compression, in terms of safety and efficacy. ClinicalTrials.gov Identifier: NCT02890563.