Calik 2019.
Study characteristics | ||
Methods |
Study design: single centre, prospective comparative (but used randomisation) Country: Turkey Setting/Location: Erzurum Regional Training and Research Hospital Source of funding: not stated Intention‐to‐treat analysis: not stated |
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Participants |
No of participants randomised: n = 400 participants, 412 procedures (EVLA = 200 (204 procedures) CA = 200 (208 procedures)) No of participants analysed: no cohort diagram EVLA = 200 (204 procedures) CA = 200 (208 procedures) Exclusions post‐randomisation: not stated Losses to follow‐up: "The 1, 3, 6 and 12 month follow‐up visits and CDUS examinations were done in 181 (90.5%) patients in the CAA group and 174 (87%) in the EVLA group" Age ‐ mean years (SD): EVLA 38.4 (11.9) CA 38.6 (11.6) Sex ‐ F/M: EVLA 114/86 CA 109/91 No. bilateral limbs randomised: EVLA 4 CA 8 Inclusion criteria: aged 18‐75 years with symptomatic varicose veins; CEAP C2‐C5; GSV insufficiency 0.5 sec determined by CDUS; could come to follow‐up examinations and mentally healthy to approve Exclusion criteria: saphenous vein duplication or accessory saphenous vein with venous insufficiency; advanced tortuous GSV; saphenous vein under 3 mm and over 15 mm diameter, history of DVT; active thrombophlebitis in deep or superficial veins; arterial insufficiency history or ABPI < 0.9; significant femoral or popliteal vein insufficiency; history of saphenous vein intervention (surgical, thermal or chemical ablation) |
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Interventions |
Treatment(s): EVLA ‐ performed under mild sedation. 1470 nm radial tip laser inserted 2 cm below SFJ. TA administrated. EVLA catheter withdrawn at 2.08 cm ± 0.6 cm/sec, 15 W power applied with external pressure from the ultrasound probe. Elastic bandage applied for 1 to 4 days. Then compression stockings (20 ‐ 30 mmHg) for one month. Control: CA ‐ performed under mild sedation. GSV punctured, 0.035' guidewire placed, delivery catheter (CA delivery system (CADS)) inserted and placed 3 cm distal to SFJ, CA injected, delivery catheter pulled back at 2 cm/sec whilst compression with ultrasound probe applied. Injection/retraction process repeated until whole segment sealed. Elastic bandage (20‐30 mmHg) applied for one day following. Duration: follow‐up was at 1 day, week 1 and at 1, 3, 6, and 12 months |
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Outcomes |
Primary outcomes: it is not clear from the paper what the specific primary or secondary outcomes were. Calik states the aims of the study were to assess the safety and efficacy of the CA in GSV in comparison to EVLA, and to present both anatomic and clinical results of 12 months follow‐up. They have reported on occlusion rates, recanalisation rates, post‐procedural complications, pain scores procedural time, VCSS, quality of life measures via the CIVIQ and time to return to daily activity. Recurrence definition: reported on recanalisation but definition not given |
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Notes | Additional phlebectomies and treatment with UGFS allowed after 3 months Use of bilateral procedures which could impact upon outcome measures such as pain, quality of life and return to work |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Consecutive treatment methods were blindly assigned by using block randomisation. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of assessors |
Incomplete outcome data (attrition bias) All outcomes | High risk | No consort diagram, losses to follow‐up not discussed, difficult to decipher how many participants were analysed at each of the time frames. |
Selective reporting (reporting bias) | High risk | The specific outcomes of the study were not explicitly stated. |
Other bias | High risk | No power calculation performed Use of bilateral procedures which could impact upon outcome measures such as pain, quality of life and return to work. No subanalysis of these participants performed. Definitions for occlusion, partial and total recanalisation never specified Use of the Wong‐Baker FACES pain scale, which is a paediatric pain assessment scale. |