Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study
Introduction Bladder cancer (BC) is a common malignancy and one of the most expensive to manage. Radical cystectomy (RC) with pelvic lymphadenectomy is a gold standard treatment for high-risk BC. Reductions in morbidity and mortality from RC may be achieved through robot-assisted RC (RARC). Prospect...
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BMJ Publishing Group
2018-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/8/8/e020500.full |
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| author | Gareth Ambler Simon Dixon Chris Brew-Graves Norman R Williams James W F Catto John D Kelly John McGrath Melanie Tan Muhammad Shamim Khan Edward Rowe Anthony Koupparis Pramit Khetrapal Rachael Sarpong Andrew Feber Louise Goodwin |
| author_facet | Gareth Ambler Simon Dixon Chris Brew-Graves Norman R Williams James W F Catto John D Kelly John McGrath Melanie Tan Muhammad Shamim Khan Edward Rowe Anthony Koupparis Pramit Khetrapal Rachael Sarpong Andrew Feber Louise Goodwin |
| author_sort | Gareth Ambler |
| collection | DOAJ |
| description | Introduction Bladder cancer (BC) is a common malignancy and one of the most expensive to manage. Radical cystectomy (RC) with pelvic lymphadenectomy is a gold standard treatment for high-risk BC. Reductions in morbidity and mortality from RC may be achieved through robot-assisted RC (RARC). Prospective comparisons between open RC (ORC) and RARC have been limited by sample size, use of extracorporeal reconstruction and use of outcomes important for ORC. Conversely, while RARC is gaining in popularity, there is little evidence to suggest it is superior to ORC. We are undertaking a prospective randomised controlled trial (RCT) to compare RARC with intracorporeal reconstruction (iRARC) and ORC using multimodal outcomes to explore qualitative and quantitative recovery after surgery.Methods and analysis iROC is a multicentre prospective RCT in English National Health Service (NHS) cancer centres. We will randomise 320 patients undergoing RC to either iRARC or ORC. Treatment allocation will occur after trial entry and consent. The primary outcome is days alive and out of hospital within the first 90 days from surgery. Secondary outcomes will measure functional recovery (activity trackers, chair-to-stand tests and health related quality of life (HRQOL) questionnaires), morbidity (complications and readmissions), cost-effectiveness (using EuroQol-5 Domain-5 levels (EQ-5D-5L) and unit costs) and surgeon fatigue. Patients will be analysed according to intention to treat. The primary outcome will be transformed and analysed using regression. All statistical assumptions will be investigated. Secondary outcomes will be analysed using appropriate regression methods. An internal feasibility study of the first 30 patients will evaluate recruitment rates, acceptance of randomised treatment choice, compliance outcome collection and to revise our sample size.Ethics and dissemination The study has ethical approval (REC reference 16/NE/0418). Findings will be made available to patients, clinicians, funders and the NHS through peer-reviewed publications, social media and patient support groups.Trial registration numbers ISRCTN13680280 and NCT03049410. |
| format | Article |
| id | doaj-art-7c94b89453b84dd5a0861a58ba2dca84 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2018-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-7c94b89453b84dd5a0861a58ba2dca842025-08-20T02:18:39ZengBMJ Publishing GroupBMJ Open2044-60552018-08-018810.1136/bmjopen-2017-020500Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility studyGareth Ambler0Simon Dixon1Chris Brew-Graves2Norman R Williams3James W F Catto4John D Kelly5John McGrath6Melanie Tan7Muhammad Shamim Khan8Edward Rowe9Anthony Koupparis10Pramit Khetrapal11Rachael Sarpong12Andrew Feber13Louise Goodwin143 Department of Statistical Science, University College London, London, UKSchool of Medicine and Population Health, The University of Sheffield, Sheffield, UK4 Surgical and Interventional Trials Unit (SITU), Division of Surgery and Interventional Science, University College London, London, UKDivision of Surgery and Interventional Science, University College London, London, UKAcademic Units of Urology and Molecular Oncology, The University of Sheffield Department of Oncology and Metabolism, Sheffield, UK2 Division of Surgery and Interventional Science, University College London, London, UK7 Department of Urology, Royal Devon and Exeter NHS Trust, Exeter, UK4 Surgical and Interventional Trials Unit (SITU), Division of Surgery and Interventional Science, University College London, London, UKUrology, Guy`s and St Thomas` Hospitals NHS Trust, London, UK6 Bristol Urology Institute, Department of Urology, North Bristol NHS Trust, Bristol, UK6 Bristol Urology Institute, Department of Urology, North Bristol NHS Trust, Bristol, UK2 Division of Surgery and Interventional Science, University College London, London, UK4 Surgical and Interventional Trials Unit (SITU), Division of Surgery and Interventional Science, University College London, London, UK2 Division of Surgery and Interventional Science, University College London, London, UK1 Academic Urology Unit, University of Sheffield, Sheffield, UKIntroduction Bladder cancer (BC) is a common malignancy and one of the most expensive to manage. Radical cystectomy (RC) with pelvic lymphadenectomy is a gold standard treatment for high-risk BC. Reductions in morbidity and mortality from RC may be achieved through robot-assisted RC (RARC). Prospective comparisons between open RC (ORC) and RARC have been limited by sample size, use of extracorporeal reconstruction and use of outcomes important for ORC. Conversely, while RARC is gaining in popularity, there is little evidence to suggest it is superior to ORC. We are undertaking a prospective randomised controlled trial (RCT) to compare RARC with intracorporeal reconstruction (iRARC) and ORC using multimodal outcomes to explore qualitative and quantitative recovery after surgery.Methods and analysis iROC is a multicentre prospective RCT in English National Health Service (NHS) cancer centres. We will randomise 320 patients undergoing RC to either iRARC or ORC. Treatment allocation will occur after trial entry and consent. The primary outcome is days alive and out of hospital within the first 90 days from surgery. Secondary outcomes will measure functional recovery (activity trackers, chair-to-stand tests and health related quality of life (HRQOL) questionnaires), morbidity (complications and readmissions), cost-effectiveness (using EuroQol-5 Domain-5 levels (EQ-5D-5L) and unit costs) and surgeon fatigue. Patients will be analysed according to intention to treat. The primary outcome will be transformed and analysed using regression. All statistical assumptions will be investigated. Secondary outcomes will be analysed using appropriate regression methods. An internal feasibility study of the first 30 patients will evaluate recruitment rates, acceptance of randomised treatment choice, compliance outcome collection and to revise our sample size.Ethics and dissemination The study has ethical approval (REC reference 16/NE/0418). Findings will be made available to patients, clinicians, funders and the NHS through peer-reviewed publications, social media and patient support groups.Trial registration numbers ISRCTN13680280 and NCT03049410.https://bmjopen.bmj.com/content/8/8/e020500.full |
| spellingShingle | Gareth Ambler Simon Dixon Chris Brew-Graves Norman R Williams James W F Catto John D Kelly John McGrath Melanie Tan Muhammad Shamim Khan Edward Rowe Anthony Koupparis Pramit Khetrapal Rachael Sarpong Andrew Feber Louise Goodwin Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study BMJ Open |
| title | Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study |
| title_full | Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study |
| title_fullStr | Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study |
| title_full_unstemmed | Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study |
| title_short | Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study |
| title_sort | robot assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy iroc protocol for a randomised controlled trial with internal feasibility study |
| url | https://bmjopen.bmj.com/content/8/8/e020500.full |
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