Syndor 2017.
| Study characteristics | ||
| Methods | Study design: prospective, single‐blinded, RCT Country: USA Setting/Location: clinic Source of funding: not stated, study authors received no financial support Intention‐to‐treat analysis: not stated | |
| Participants | No of participants randomised: 200 participants; RFA = 100; EVLA = 100 No of participants analysed: RFA = 100, EVLA = 100 Exclusions post‐randomisation: nil Losses to follow‐up: 6 weeks RFA = 97, EVLA = 96; 6 months EVLA = 79, RFA = 74 Age mean (range): RFA = 47 (19 ‐ 86); EVLA = 48.5 (23 ‐ 86) Sex ‐ F/M: EVLA 77/23; RFA 80/20 Inclusion criteria: CVI symptoms caused by GSV reflux (reversed flow in GSV > 0.5 s after calf compression in a standing position); CEAP > 2; prior attempt of at least 6 weeks of compression stockings for CVI Exclusion criteria: previous vein surgery/EVTA/phlebectomy in target extremity excluding sclerosant injection for spider veins; active or prior DVT; active or prior hypercoagulability; people who are breastfeeding; people who are non‐ambulatory; age < 18 yrs; prisoners | |
| Interventions |
Treatment description: RFA: office‐based majority without conscious sedation, tumescent anaesthesia. Heat (120 oC) segmentally 20 s cycles spaced 6.5 cm apart via VNUS ClosureFAST technology (2 consecutive cycles delivered 1 ‐ 2 cm distal to the SFJ and all other segments were treated with 1 cycle. Stockings continuously 24 hrs then during day for 14 days
Control description: EVLA: office‐based majority without conscious sedation, tumescent anaesthesia. 980 nm diode laser system (AngioDynamics, Qeensbury NY) at a fluence range of 50 ‐ 80 J and power back power of 10 W with a constant continuous pullback. Stockings continuously 24 hrs then during day for 14 days. Duration: post‐procedure review within 7 days, 6 weeks, 6 months |
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| Outcomes | Primary outcomes: technical success (closure of GSV with no new reflux, neovascularity or other refluxing truncal veins) Secondary outcomes: pain during procedure (1 ‐ 10), haematoma, paraesthesia, thermal injury, overall satisfaction, satisfaction within 7 days, 6 weeks and 6 months | |
| Notes | Participants were offered ambulatory phlebectomies or UGFS Conscious sedation commonly administered when adjunctive ambulatory phlebectomy performed |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation was performed in blocks of two, four or six participants |
| Allocation concealment (selection bias) | Low risk | "Objective data recorded by nurse practitioner blinded with regards to which EVTA procedure the patient had undergone. All patient charts with photographs were kept in a locked office and the patient database was kept in a secure password protected format. Patients were blinded" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and personnel blinded. "Objective data recorded by nurse practitioner blinded with regards to which EVTA procedure the patient had undergone. All patient charts with photographs were kept in a locked office and the patient database was kept in a secure password protected format. Patients were blinded" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Objective data recorded by nurse practitioner blinded with regards to which EVTA procedure the patient had undergone. All patient charts with photographs were kept in a locked office and the patient database was kept in a secure password protected format." Participants were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts reported, reasons not given |
| Selective reporting (reporting bias) | Low risk | All predefined outcomes reported |
| Other bias | Unclear risk | Phlebectomies and UGFS performed concomitantly Conscious sedation used Wide range in follow‐up dates (i.e. some 6‐week reviews were done at 1 yr; initial follow‐up ranged from 1 to 29 days) No power analysis |