The VIOLET study
VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer, a multi-centre randomised controlled trial with an internal pilot
Royal Brompton & Harefield NHS Foundation Trust
Duration of Study in the UK
5 years, 8 months, 30 days
Lung cancer is the leading cause of cancer death worldwide and survival in the UK remains low. Surgery is the mainstay of the cure, although it is associated with serious complications. Recently, minimal access video assisted thoracoscopic surgery (VATS) for lung cancer has been introduced. VATS leads to less tissue trauma than open surgery and there are small randomised trials and some case series showing it is safe; however, it is unknown whether it improves patient outcome. Therefore, the aim of the VIOLET study is to generate high quality evidence to support (or refute) the provision of VATS by comparing open surgery with minimal access VATS in a randomised controlled trial (RCT). The study will compare the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open surgery for treatment of lung cancer.
The VIOLET study aims to recruit 498 patients from ten hospitals (NHS Trusts) across the UK. Adult patients will have been diagnosed with known or suspected early-stage lung cancer and will be randomised to either VATS or open surgery. Patient quality of life, clinical outcomes and economic variables will be compared. The study also involves an inbuilt qualitative component to help understand the recruitment process at each site. Trial involvement will cease 1 year after recruitment. Results from the study will inform clinical understanding and influence surgical practice in the UK.
London - Dulwich Research Ethics Committee
Date of REC Opinion
7 Jan 2015
Further Information Favourable Opinion