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)
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...
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| author | Tim Batchelor Babu Naidu Chris A Rogers Jane Blazeby Alan Kirk Paula Rogers Stacey Stewart Syed Qadri Fiona Strachan Sarah Wordsworth Susan J Dutton Arjun Nair Amy Kerr Rajesh Shah Lisa Jones Elizabeth A Stokes Mark Ainsworth Kathryn Saunders Daisy Elliott Rosie Harris Sangeetha Paramasivan Tom Treasure Martyn Cain Eric Lim Michael Shackcloth Joel Dunning Niall McGonigle Tim Brush Lucy Dabner Holly E Mckeon Dawn Phillips Holly Mckeon Chloe Beard Alba Realpe Rojas Elizabeth Stokes Andrew G Nicholson Sofina Begum Simon Jordan Paulo De Sousa Monica Tavares Barbosa Eveline Internullo Rakesh Krishnadas Gianluca Casali Doug West Karen Bobruk Catherine O’Donovan Louise Flintoff Amelia Lowe Joanna Nicklin Emma Heron Jo Chambers Becky Houlihan Laura Beacham Heather Hudson Katy Tucker Toni Farmery Danielle Davis Mike Shackcloth Julius Asante-Siaw Susannah Love Sarah Feeney Lindsey Murphy Almudena Duran Rosas Andrea Young Ian Paul Hyder Latif Charlotte Jacobs Alison Chilvers Edward Stephenson Nazalie Iqbal Vladimir Anikin Claire Prendergast Hazem Fallouh Maninder Kalkat Richard Steyn Nicola Oswald Charlotte Ferris Jo Webb Joanne Taylor Hollie Bancroft Salma Kadiri Zara Jalal Senior Elizabeth Belcher Dionisios Stavroulias Francesco Di Chiara May Havinden-Williams Mahmoud Loubani Karen Dobbs Paul Atkin Dominic Fellowes Leanne Cox Vipin Zamvar Ruth Langley Joy Adamson Ian Hunt Peter B Licht Chris Hall Mike Cowen Keith Kerr Nagmi Qureshi |
| author_facet | Tim Batchelor Babu Naidu Chris A Rogers Jane Blazeby Alan Kirk Paula Rogers Stacey Stewart Syed Qadri Fiona Strachan Sarah Wordsworth Susan J Dutton Arjun Nair Amy Kerr Rajesh Shah Lisa Jones Elizabeth A Stokes Mark Ainsworth Kathryn Saunders Daisy Elliott Rosie Harris Sangeetha Paramasivan Tom Treasure Martyn Cain Eric Lim Michael Shackcloth Joel Dunning Niall McGonigle Tim Brush Lucy Dabner Holly E Mckeon Dawn Phillips Holly Mckeon Chloe Beard Alba Realpe Rojas Elizabeth Stokes Andrew G Nicholson Sofina Begum Simon Jordan Paulo De Sousa Monica Tavares Barbosa Eveline Internullo Rakesh Krishnadas Gianluca Casali Doug West Karen Bobruk Catherine O’Donovan Louise Flintoff Amelia Lowe Joanna Nicklin Emma Heron Jo Chambers Becky Houlihan Laura Beacham Heather Hudson Katy Tucker Toni Farmery Danielle Davis Mike Shackcloth Julius Asante-Siaw Susannah Love Sarah Feeney Lindsey Murphy Almudena Duran Rosas Andrea Young Ian Paul Hyder Latif Charlotte Jacobs Alison Chilvers Edward Stephenson Nazalie Iqbal Vladimir Anikin Claire Prendergast Hazem Fallouh Maninder Kalkat Richard Steyn Nicola Oswald Charlotte Ferris Jo Webb Joanne Taylor Hollie Bancroft Salma Kadiri Zara Jalal Senior Elizabeth Belcher Dionisios Stavroulias Francesco Di Chiara May Havinden-Williams Mahmoud Loubani Karen Dobbs Paul Atkin Dominic Fellowes Leanne Cox Vipin Zamvar Ruth Langley Joy Adamson Ian Hunt Peter B Licht Chris Hall Mike Cowen Keith Kerr Nagmi Qureshi |
| author_sort | Tim Batchelor |
| collection | DOAJ |
| description | 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 |
| format | Article |
| id | doaj-art-30fdc3dd177c44b1ab3f1fb7e3e31571 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-30fdc3dd177c44b1ab3f1fb7e3e315712025-08-20T02:50:29ZengBMJ Publishing GroupBMJ Open2044-60552019-10-0191010.1136/bmjopen-2019-029507Study 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)Tim Batchelor0Babu Naidu1Chris A Rogers2Jane Blazeby3Alan KirkPaula Rogers4Stacey Stewart5Syed QadriFiona StrachanSarah Wordsworth6Susan J Dutton7Arjun Nair8Amy Kerr9Rajesh Shah10Lisa Jones11Elizabeth A Stokes12Mark Ainsworth13Kathryn Saunders14Daisy Elliott15Rosie Harris16Sangeetha Paramasivan17Tom Treasure18Martyn CainEric Lim19Michael Shackcloth20Joel Dunning21Niall McGonigle22Tim Brush23Lucy Dabner24Holly E Mckeon25Dawn Phillips26Holly Mckeon27Chloe Beard28Alba Realpe RojasElizabeth StokesAndrew G Nicholson29Sofina BegumSimon JordanPaulo De SousaMonica Tavares BarbosaEveline InternulloRakesh KrishnadasGianluca Casali30Doug West31Karen BobrukCatherine O’DonovanLouise FlintoffAmelia LoweJoanna Nicklin32Emma HeronJo ChambersBecky HoulihanLaura BeachamHeather HudsonKaty TuckerToni FarmeryDanielle DavisMike ShackclothJulius Asante-SiawSusannah LoveSarah FeeneyLindsey MurphyAlmudena Duran RosasAndrea YoungIan PaulHyder LatifCharlotte JacobsAlison ChilversEdward StephensonNazalie IqbalVladimir Anikin33Claire Prendergast34Hazem Fallouh35Maninder Kalkat36Richard Steyn37Nicola OswaldCharlotte FerrisJo WebbJoanne TaylorHollie BancroftSalma Kadiri38Zara Jalal SeniorElizabeth Belcher39Dionisios Stavroulias40Francesco Di ChiaraMay Havinden-WilliamsMahmoud LoubaniKaren DobbsPaul AtkinDominic FellowesLeanne CoxVipin Zamvar41Ruth Langley42Joy Adamson43Ian Hunt44Peter B LichtChris HallMike CowenKeith KerrNagmi QureshiCardiothoracic Surgery, Barts Health NHS Trust, London, UKDepartment of Thoracic Surgery, University Hospitals Birmingham, Birmingham, UK1 Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UKprofessorRoyal Brompton & Harefield NHS Foundation Trust Hospital, Uxbridge, UKBHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UKUniversity of Oxford, University of Oxford, Oxford, UKCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UKUniversity College Hospital, London, UKDepartment of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKDepartment of Thoracic Surgery, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK5 Medicine, Division of Pulmonary and Critical Care Medicine, University of Florida College of Medicine – Jacksonville, Jacksonville, Florida, USAHealth Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK3 Oxford Liver Unit, Department of Gastroenterology and Hepatology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK6 Biomedical Sciences Research Institute, Ulster University, Coleraine, UKNational Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK1 Bristol Medical School, University of Bristol Faculty of Health Sciences, Bristol, UKPopulation Health Sciences, University of Bristol, Bristol, UKprofessor of cardiothoracic surgeryDepartment of Thoracic Surgery, Royal Brompton Hospital, London, UK3 Department of Thoracic Surgery, Liverpool Heart and Chest Hospital, Liverpool, UKDepartment of Cardiothoracic Surgery, James Cook University Hospital, Middlesbrough, UK5 Department of Thoracic Surgery, Royal Brompton and Harefield, Harefield Hospital, London, UKBristol Trials Centre (CTEU), Bristol Medical School, University of Bristol, Bristol, UK6 Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK6 Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UKBlood Safety, Hepatitis, STI and HIV Division, UK Health Security Agency, London, UKBristol Trials Centre, Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, UKBristol Trials Centre, University of Bristol Medical School, Bristol, UK2 Respiratory Pathology, National Heart and Lung Institute, Imperial College London, London, UKDepartment of Surgery, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK6 Thoracic Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UKDivision of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UKBiosciences, College of Health, Medicine and Life Sciences, Brunel University London, Uxbridge, UK1Dorothy House Hospice Care, Winsley, UKInstitute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UKInstitute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UKDepartment of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKDepartment of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKOxford University Hospitals NHS Foundation Trust, Oxford, UKDepartment of Thoracic Surgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UKCardiothoracic Surgery, Royal Infirmary of Edinburgh, Edinburgh, UKInstitute of Clinical Trials and Methodology - MRC CTU at UCL, University College London, London, UKDepartment of Health Sciences, University of York, York, UK2College of Sciences and Engineering, University of Tasmania, Tasmania, TAS, AustraliaIntroduction 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 ISRCTN13472721https://bmjopen.bmj.com/content/9/10/e029507.full |
| spellingShingle | Tim Batchelor Babu Naidu Chris A Rogers Jane Blazeby Alan Kirk Paula Rogers Stacey Stewart Syed Qadri Fiona Strachan Sarah Wordsworth Susan J Dutton Arjun Nair Amy Kerr Rajesh Shah Lisa Jones Elizabeth A Stokes Mark Ainsworth Kathryn Saunders Daisy Elliott Rosie Harris Sangeetha Paramasivan Tom Treasure Martyn Cain Eric Lim Michael Shackcloth Joel Dunning Niall McGonigle Tim Brush Lucy Dabner Holly E Mckeon Dawn Phillips Holly Mckeon Chloe Beard Alba Realpe Rojas Elizabeth Stokes Andrew G Nicholson Sofina Begum Simon Jordan Paulo De Sousa Monica Tavares Barbosa Eveline Internullo Rakesh Krishnadas Gianluca Casali Doug West Karen Bobruk Catherine O’Donovan Louise Flintoff Amelia Lowe Joanna Nicklin Emma Heron Jo Chambers Becky Houlihan Laura Beacham Heather Hudson Katy Tucker Toni Farmery Danielle Davis Mike Shackcloth Julius Asante-Siaw Susannah Love Sarah Feeney Lindsey Murphy Almudena Duran Rosas Andrea Young Ian Paul Hyder Latif Charlotte Jacobs Alison Chilvers Edward Stephenson Nazalie Iqbal Vladimir Anikin Claire Prendergast Hazem Fallouh Maninder Kalkat Richard Steyn Nicola Oswald Charlotte Ferris Jo Webb Joanne Taylor Hollie Bancroft Salma Kadiri Zara Jalal Senior Elizabeth Belcher Dionisios Stavroulias Francesco Di Chiara May Havinden-Williams Mahmoud Loubani Karen Dobbs Paul Atkin Dominic Fellowes Leanne Cox Vipin Zamvar Ruth Langley Joy Adamson Ian Hunt Peter B Licht Chris Hall Mike Cowen Keith Kerr Nagmi Qureshi 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/9/10/e029507.full |
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studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT mahmoudloubani studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT karendobbs studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT paulatkin studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT dominicfellowes studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT leannecox studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT vipinzamvar studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT ruthlangley studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT joyadamson studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT ianhunt studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT peterblicht studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT chrishall studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT mikecowen studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT keithkerr studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy AT nagmiqureshi studyprotocolforvideoassistedthoracoscopiclobectomyversusconventionalopenlobectomyforlungcanceraukmulticentrerandomisedcontrolledtrialwithaninternalpilotthevioletstudy |