Flessenkämper 2013.

Study characteristics
Methods	Study design: multicentre, prospective, RCT Country: Germany Setting/Location: 1) Centre for Vascular Medicine, Helios Klinikum Emil von Behring, Berlin 2) Centre for Venous Diseases, Frieburg 3) Centre for Venous Diseases, Saarlois Source of funding: sponsored by Deutschen Gessellschaft für Phlebologie (DGP) Intention‐to‐treat analysis: not indicated
Participants	No of participants randomised: total n = 449 (EVLT n = 142; EVLT+HL n = 148; HL/S n = 159). Details of the EVLT+HL group are reported here but were not used in this review. No of participants analysed: 100% at 2 months; 86% at 6 months; total n = 385 (EVLT n = 127; EVLT+HL n = 133; HL/S n = 128) Exclusions post‐randomisation: not indicated Losses to follow‐up: at 6 months EVLT n = 15; EVLT+HL n = 15; HL/S n = 39 Age ‐ mean years (SD): EVLT 47.4 (12.9); EVLT+HL 48.7 (12.0); HL/S 47.7 (11.5) Sex ‐ M/F: EVLT 45/97; EVLT+HL 37/111; HL/S 47/112 Inclusion criteria: people between 18 and 72 years old with clinical signs or symptoms of superficial venous insufficiency with proven reflux into GSV, with a life expectancy of more than 5 years; all people suitable for open and endoluminal therapy with diameter of GSV not exceeding 16 mm at a point 5 cm distal to the SFJ Exclusion criteria: previous surgery of the GSV was the only reported exclusion criteria
Interventions	Treatment(s): EVLT: laser therapy with a 980 nm diode laser, used local tumescent and general anaesthesia EVLT with high ligation (EVLT+HL): EVLT performed combined with HL, under general anaesthesia. Both EVLT procedures performed with instruments from Biolitec Jena, Germany (30 W) Control: HL/S: resection of all branches down to the dorsal level of the femoral vein; under general anaesthesia Duration: follow‐up at 2, 6, 12 and 24 months for re‐examination, then followed participants as long as possible
Outcomes	Primary outcomes: inguinal venous reflux after 2 yrs Secondary outcomes: peri‐operative technical success rate, rate of hyperpigmentation and matting, neurological compilations, duration of compression therapy and lymphoedema, complications, post‐operative ecchymosis, pain (visual analogue scale 1 ‐10) or discomfort, duration of disability, participant satisfaction, clinical severity (CEAP, VCSS, Hach classification, VDS) Recurrence definition: any reflux more than 0.5 s from the SFJ into the GSV, which was assessed by physicians by DUS ultrasound at 2‐yr follow‐up
Notes	May 2005 to July 2009 Reflux was defined as retrograde flow of > 0.5 s duration after Valsalva manoeuvre or manual compression and decompression of distal vein Nearly all participants were treated as inpatients All 3 groups had simultaneous mini‐phlebectomies, as required
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Used lottery ticket box at central office and telephone randomisation
Allocation concealment (selection bias)	Low risk	Used central office and telephone randomisation
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding of participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of assessor. "Because of the scars, blinding for the follow‐up was not possible"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Dropouts reported but no reasons given
Selective reporting (reporting bias)	Low risk	All outcomes reported on
Other bias	Unclear risk	Possibly underpowered; power calculation described a need for 469 participants, but only 449 were randomised Number of participants needing additional phlebectomies was not recorded, which could affect post‐operative pain, QoL, etc.