Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial

Trials

  ^{1    2    3    4} 

[1] 0000 0001 2113 8111, grid.7445.2, Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK;0000 0001 2113 8111, grid.7445.2, Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK;0000 0001 0693 2181, grid.417895.6, Imperial College Healthcare NHS Trust, London, UK;0000 0001 2113 8111, grid.7445.2, Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK;Specialty Training Registrar in Vascular Surgery, East of England Deanery, UK;0000 0001 2113 8111, grid.7445.2, Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK;Specialty Training Registrar in Vascular Surgery, London Deanery, UK;0000 0001 0693 2181, grid.417895.6, Imperial College Healthcare NHS Trust, London, UK;

关键词: Phlebectomy;    foam sclerotherapy;    superficial venous disease;    varicose veins;    varicosity treatment;   

DOI  :  10.1186/s13063-019-3398-0

来源: publisher

【 摘 要 】

BackgroundAmbulatory phlebectomies and foam sclerotherapy are two of the most common treatments for varicose vein tributaries. Many studies have been published on these treatments, but few comparative studies have attempted to determine their relative effectiveness.Methods/designThis is a prospective single-centre randomised clinical trial. Patients with primary truncal vein incompetence and varicose vein tributaries requiring treatment will be assigned randomly to either ambulatory phlebectomies or foam sclerotherapy. The primary outcome measure is the re-intervention rate for the varicose vein tributaries during the study period. The secondary outcomes include the degree of pain during the first two post-operative weeks and the time to return to usual activities or work. Improvements in clinical scores, quality of life scores, occlusion rates and cost-effectiveness for each intervention are other secondary outcomes. The re-intervention rate will be considered from the third month.DiscussionThis study compares ambulatory phlebectomies and foam sclerotherapy in the treatment of varicose vein tributaries. The re-intervention rates, safety, patient experience and the cost-effectiveness of each intervention will be assessed. This study aims to recruit 160 patients and is expected to be completed by the end of 2019.Trial registrationClinicalTrials.gov, NCT03416413. Registered on 31 January 2018.

【 授权许可】

CC BY