Study protocol for VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer, a UK multicentre randomised controlled trial with an internal pilot (the VIOLET study). Issue 10 (14th October 2019)

• Record Type: Journal Article
• Authors: Lim, Eric; Batchelor, Tim; Shackcloth, Michael; Dunning, Joel; McGonigle, Niall; Brush, Tim; Dabner, Lucy; Harris, Rosie; Mckeon, Holly E; Paramasivan, Sangeetha; Elliott, Daisy; Stokes, Elizabeth A; Wordsworth, Sarah; Blazeby, Jane; Rogers, Chris A
• Other Names: author non-byline.; Lim Eric author non-byline.; Rogers Chris A author non-byline.; Brush Tim author non-byline.; Dabner Lucy author non-byline.; Phillips Dawn author non-byline.; Mckeon Holly author non-byline.; Beard Chloe author non-byline.; Harris Rosie author non-byline.; Elliott Daisy author non-byline.; Paramasivan Sangeetha author non-byline.; Rojas Alba Realpe author non-byline.; Wordsworth Sarah author non-byline.; Stokes Elizabeth author non-byline.; Blazeby Jane author non-byline.; Nicholson Andrew G author non-byline.; Begum Sofina author non-byline.; Jordan Simon author non-byline.; Sousa Paulo De author non-byline.; Barbosa Monica Tavares author non-byline.; Batchelor Tim author non-byline.; Internullo Eveline author non-byline.; Krishnadas Rakesh author non-byline.; Casali Gianluca author non-byline.; West Doug author non-byline.; Bobruk Karen author non-byline.; O'Donovan Catherine author non-byline.; Flintoff Louise author non-byline.; Lowe Amelia author non-byline.; Nicklin Joanna author non-byline.; Heron Emma author non-byline.; Chambers Jo author non-byline.; Houlihan Becky author non-byline.; Beacham Laura author non-byline.; Hudson Heather author non-byline.; Tucker Katy author non-byline.; Farmery Toni author non-byline.; Davis Danielle author non-byline.; Shackcloth Mike author non-byline.; Asante-Siaw Julius author non-byline.; Love Susannah author non-byline.; Feeney Sarah author non-byline.; Murphy Lindsey author non-byline.; Rosas Almudena Duran author non-byline.; Young Andrea author non-byline.; Dunning Joel author non-byline.; Paul Ian author non-byline.; Latif Hyder author non-byline.; Jacobs Charlotte author non-byline.; Chilvers Alison author non-byline.; Stephenson Edward author non-byline.; Cain Martyn author non-byline.; Iqbal Nazalie author non-byline.; Anikin Vladimir author non-byline.; McGonigle Niall author non-byline.; Prendergast Claire author non-byline.; Jones Lisa author non-byline.; Rogers Paula author non-byline.; Naidu Babu author non-byline.; Fallouh Hazem author non-byline.; Hernandez Luis author non-byline.; Kalkat Maninder author non-byline.; Steyn Richard author non-byline.; Oswald Nicola author non-byline.; Kerr Amy author non-byline.; Ferris Charlotte author non-byline.; Webb Jo author non-byline.; Taylor Joanne author non-byline.; Bancroft Hollie author non-byline.; Kadiri Salma author non-byline.; Senior Zara Jalal author non-byline.; Belcher Elizabeth author non-byline.; Stavroulias Dionisios author non-byline.; Chiara Francesco Di author non-byline.; Saunders Kathryn author non-byline.; Havinden-Williams May author non-byline.; Ainsworth Mark author non-byline.; Loubani Mahmoud author non-byline.; Qadri Syed author non-byline.; Dobbs Karen author non-byline.; Atkin Paul author non-byline.; Fellowes Dominic author non-byline.; Cox Leanne author non-byline.; Zamvar Vipin author non-byline.; Marshall Lucy author non-byline.; Strachan Fiona author non-byline.; Stewart Stacey author non-byline.; Langley Ruth author non-byline.; Adamson Joy author non-byline.; Hunt Ian author non-byline.; Licht Peter B author non-byline.; Nair Arjun author non-byline.; Hall Chris author non-byline.; Cowen Mike author non-byline.; Dutton Susan J author non-byline.; Kirk Alan author non-byline.; Kerr Keith author non-byline.; Shah Rajesh author non-byline.; Qureshi Nagmi author non-byline.; Treasure Tom author non-byline.;
• Is Part Of: BMJ open. Volume 9:Issue 10(2019)
• Publication Date: 2019-10-14
• Subjects: randomised controlled trial -- minimally invasive -- Cardiothoracic surgery -- open surgery -- video assisted -- lung cancer -- lobectomy; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-029507
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Lung cancer is a leading cause of cancer deaths worldwide and surgery remains the main treatment for early stage disease. Prior to the introduction of video-assisted thoracoscopic surgery (VATS), lung resection for cancer was undertaken through an open thoracotomy. To date, the evidence base supporting the different surgical approaches is based on non-randomised studies, small randomised trials and is focused mainly on short-term in-hospital outcomes. Methods and analysis: The VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer study is a UK multicentre parallel group randomised controlled trial (RCT) with blinding of outcome assessors and participants (to hospital discharge) comparing the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open lobectomy for treatment of lung cancer. We will test the hypothesis that VATS lobectomy is superior to open lobectomy with respect to self-reported physical function 5 weeks after randomisation (approximately 1 month after surgery). Secondary outcomes include assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pathologic N2 (pN2) disease and disease-free survival), overall survival and health related quality of life to 1 year. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment. Ethics and dissemination: This trial has been approved by the UK (Dulwich) National Research Ethics Service Committee London. Findings will be written-up as methodology papers for conference presentation, and publication in peer-reviewed journals. Many aspects of the feasibility work will inform surgical RCTs in general and these will be reported at methodology meetings. We will also link with lung cancer clinical studies groups. The patient and public involvement group that works with the Respiratory Biomedical Research Unit at the Brompton Hospital will help identify how we can best publicise the findings. Trial registration number: ISRCTN13472721