Magna 2013.
| Study characteristics | ||
| Methods |
Study design: sIngle‐centre*, prospective, RCT (* second centre was added in May 2009 due to slow inclusion rate) Country: the Netherlands Setting/Location: Departments of Dermatology and Vascular Surgery in two hospitals Source of funding: Erasmus Medical Centre listed under Sponsors and Collaborators Intention‐to‐treat analysis: yes |
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| Participants |
No of participants randomised: total n = 240 legs (EVLT n = 80 legs; UGFS n = 80 legs; HL/S n = 80 legs) No of participants analysed: total n = 223 legs (EVLT n = 78 legs; UGFS n = 77 legs; HL/S n = 68 legs) Exclusions post‐randomisation: not indicated Losses to follow‐up: total n = 1 (EVLT n = 0; UGFS n = 1; HL/S n = 0) Age ‐ mean years (SD): EVLT 49 (15.03); UGFS 56 (13.30); HL/S 52 (15.59) Sex ‐ M/F: EVLT 24/54; UGFS 25/52; HL/S 22/46 No bilateral limbs randomised: EVLT 16, UGFS 19, HL/S 17 Inclusion criteria: adults with symptomatic primary incompetent GSV at least above the knee with a diameter ≥ 0.5 cm; with an incompetent SFJ (incompetence defined as reflux ≥ 0.5 s at colour DUS Exclusion criteria: previous treatment of the ipsilateral GSV; deep venous incompetence or obstruction; agenesis of the deep system; vascular malformations; use of anticoagulant; pregnancy; heart failure; contraindication for one of the treatments; immobility; arterial insufficiency; age under 18 yrs; inability to provide written informed consent |
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| Interventions |
Treatment(s): EVLT (940 nm diode laser): performed under UG tumescent anaesthetic UGFS: prepared foam made with 1 cc aethoxysclerol 3%, 3 cc air; if considered necessary procedure could be repeated after 3 months; no manufacturer information given Control: HL/S: high ligation with short (above knee) stripping; performed under spinal or general anaesthesia Duration: evaluated at 3 months, 12 months and 5 yrs |
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| Outcomes |
Primary outcomes: anatomic success according to DUS, neovascularisation Secondary outcomes: C of the CEAP classification; type and frequency of complications; QoL (CIVIQ and EuroQol‐5D) Recurrence definition: for the UGFS and EVLT groups ‐ flow or reflux of the GSV at midthigh; for surgery ‐ presence of the GSV in the saphenous compartment at thigh level (both groups evaluated by clinical examination and DUS) |
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| Notes | January 2007 to May 2010 Intention for additional phlebectomies was to perform during initial treatment, but in several cases were performed after 3 months (during initial treatment: EVLT n = 15; UGFS n = 0; HL/S n = 18; after 3 months: EVLT n = 12; UGFS n = 15; HL/S n = 11) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...randomised using a computerized list by an independent research nurse." |
| Allocation concealment (selection bias) | Low risk | "...randomised using a computerized list by an independent research nurse." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No indication of blinding of participants and personnel |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No indication of blinding of assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts and reasons were thoroughly reported |
| Selective reporting (reporting bias) | Unclear risk | For complications, study authors stated they would report on migraine, skin burns, skin necrosis, and anaphylactic shock. No data were presented for these outcomes. |
| Other bias | Unclear risk | Possibly underpowered; power calculation described a need for 240 participants, but only 223 were analysed. Also unclear how QoL was evaluated for bilaterally treated participants ‐ study authors do not clarify |