Randomised controlled comparison study of endoleuminal Laser versus Foam Sclerotherapy in Treatment of Varicose veins

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
INTERVENTION: Varicose vein surgery is a common operation with between 400 and 500 cases performed each year in Nottingham. Traditional Varicose vein surgery for the long saphenous system (LSV) consists of a high ligation, involving a cut in the groin and multiple avulsions, dealing with the varicosities in the legs. This requires general anaesthesia and is performed as a day case or inpatient treatment with one night in hospital. For patients, traditional surgery results in pain, extensive bruising, limited mobility and a delayed return to normal activity lasting up to six weeks, although more usually only two weeks. Surgery needs to be performed by surgeons who have achieved competence in the procedure. Recently, new methods for treating varicose veins have been introduced into the independent healthcare sector. These give patients a choice of procedures and some allow varicose veins to be treated without general anaesthesia. In addition, patients report less pain, bruising and an early return to normal activity. These new procedures are endoluminal thermal ablation (VNUS), endovenous laser therapy (EVLT), venocuff valve reinforcement and Varicofoam therapy. The NHS modernisation programme aims to increase the use of day case surgery, enhance patient choice , Increased day case activity in Nottingham can be performed in the new diagnostic and treatment centre (DTC). The aim of this study is to compare the latest treatments for varicose veins using established outcome assessments verified by previous studies performed in the department of vascular surgery at the QMC. Study design: The study comprises randomised study comparing different approaches to the treatment of long and short saphenous disease. Patients will be given a copy of the information sheet. They will be given time to consider their decision and when they wish to enter, they will be asked to sign the study consent form. A copy will be given to patient, one will be placed in their clinical notes and one will be kep CONDITION: Cardiovascular: Varicose veins ; Circulatory System ; Varicose veins PRIMARY OUTCOME: Pain, bruising and patient satisfaction, number of treatment episodes required. SECONDARY OUTCOME: 1. Time to perform procedure, time in hospital, cost, recurrence rates; 2. Complications INCLUSION CRITERIA: Men and women requesting treatment for bilateral varicose veins who present to the Vascular Clinics at the Queen's Medical Centre, City Hospital and independent hospitals within Nottinghamshire (UK).
Epistemonikos ID: f2a12ba28b59195376262f1f3810ed9967d16204
First added on: Aug 21, 2024