Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT)
| العنوان: | Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT) |
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| المؤلفون: | Martyn Lee Humphreys, Christopher Streets, Chris A Rogers, Naheed Farooq, Anni Skilton, Kerry N L Avery, Timothy J. Underwood, James P. Byrne, Newton Wong, Carolyn Hindmarsh, Grant Sanders, Rachel Cm Brierley, Richard J E Skipworth, Natalie S Blencowe, Robin A Wickens, Kish Pursnani, Bilal Alkhaffaf, Joanna Nicklin, R Berrisford, Nicola Rea, Simon L. Parsons, Jill Cooke, Alexander P. Boddy, Richard Krysztopik, Chris Metcalfe, David J. Bowrey, William Hollingworth, Fergus Noble, Arun Ariyarathenam, Marcus Jepson, Rachel Schranz, Ram Chaparala, Rebecca J Houlihan, David Exon, Paul Wilkerson, Tim Wheatley, Jamie Kelly, Graeme Couper, Lucy Culliford, Sally Maitland, Rachael Heys, Caoimhe Rice, Chris Deans, Sukhbir Ubhi, Lucy Howie, R S Vohra, James A Catton, Jenny L Donovan, CP Barham, Jane M Blazeby, Peter Lamb, Katy A Chalmers, Alexandra Williams, Sian Cousins, Paul Turner, Neil T. Welch, Dan Titcomb, Aida Moure-Fernandez, Khurshid Akhtar, Vinutha Daya Shetty, Rachel Melhado, Andrew Hollowood, Robert N. Williams, Daisy Gaunt, Joanne Smith, Benjamin Howes, Jackie Elliott |
| المصدر: | BMJ Open Brierley, RC, Gaunt, D, Metcalfe, C, Blazeby, JM, Blencowe, NS, Jepson, M, Berrisford, RG, Avery, KNL, Hollingworth, W, Rice, CT, Moure-Fernandez, A, Wong, N & Barham, CP 2019, ' Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT). ', BMJ Open . https://doi.org/10.1136/bmjopen-2019-030907Test Brierley, R C M, Gaunt, D M, Metcalfe, C, Blazeby, J M, Blencowe, N S, Jepson, M, Berrisford, R, Avery, K N L, Hollingworth, W, Rice, C, Moure Fernandez, A, Wong, N A C S, Nicklin, J K, Skilton, A, Boddy, A P, Byrne, J, Underwood, T, Vohra, R S, Catton, J A, Pursnani, K, Melhado, R, Alkhaffaf, B, Krysztopik, R, Lamb, P, Culliford, L A, Rogers, C A, Howes, B, Chalmers, K A, Cousins, S E, Elliott, J, Donovan, J L, Heys, R L, Wickens, R A, Wilkeron, P, Hollowood, A, Streets, C G, Titcomb, D R, Humphreys, M L, Wheatley, T, Sanders, G, Ariyarathenam, A, Kelly, J, Noble, F, Couper, G, Skipworth, R J E, Deans, C, Ubhi, S, Williams, R, Bowrey, D, Exon, D, Turner, P, Shetty, V, Chaparala, R, Akhtar, K, Farooq, N, Parsons, S, Welch, N, Houlihan, R, Smith, J, Schranz, R, Rea, N, Cooke, J, Williams, A, Hindmarsh, C, Maitland, S, Howie, L & Barham, C P 2019, ' Laparoscopically assisted vs open oesophagectomy for patients with oesophageal cancer – the ROMIO (Randomised Oesophagectomy : Minimally Invasive or Open) study: protocol for a randomized controlled trial (RCT) ', BMJ Open, vol. 9, e030907 . https://doi.org/10.1136/bmjopen-2019-030907Test Brierley, R, Gaunt, D M, Metcalfe, C, Blazeby, J M, Blencowe, N S, Jepson, M, Berrisford, R, Avery, K N L, Hollingworth, W, Rice, C T, Moure-Fernandez, A, Wong, N A, Nicklin, J, Skilton, A, Boddy, A, Byrne, J, Underwood, T, Vohra, R, Catton, J A, Pursnani, K, Melhado, R, Alkhaffaf, B, Krysztopik, R, Lamb, P, Culliford, L A, Rogers, C A, Howes, B, Chalmers, K, Cousins, S, Elliott, J, Donovan, J, Heys, R, Wickens, R A, Wilkerson, P, Hollowood, A, Streets, C, Titcomb, D, Humphreys, M L, Wheatley, T, Sanders, G, Ariyarathenam, A, Kelly, J, Noble, F, Couper, G W, Skipworth, R J E, Deans, C, Ubhi, S, Williams, R, Bowrey, D, Exon, D, Turner, P, Shetty, V, Chaparala, R, Akhtar, K, Farooq, N, Parsons, S L, Welch, N T, Houlihan, R J, Smith, J, Schranz, R, Rea, N, Cooke, J, Williams, A, Hindmarsh, C, Maitland, S, Howie, L & Barham, C P 2019, ' Laparoscopically assisted vs open oesophagectomy for patients with oesophageal cancer – the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial (RCT) ', BMJ Open . https://doi.org/10.1136/bmjopen-2019-030907Test |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Male, Esophageal Neoplasms, Cost-Benefit Analysis, Physical function, law.invention, 0302 clinical medicine, Postoperative Complications, Randomized controlled trial, Quality of life, Clinical Protocols, law, Protocol, 030212 general & internal medicine, Aged, 80 and over, Surgical approach, Manchester Cancer Research Centre, General Medicine, Middle Aged, minimally invasive oesophagectomy, Treatment Outcome, Carcinoma, Squamous Cell, Regression Analysis, BRTC, Female, Adult, medicine.medical_specialty, oesophageal cancer, Blinding, Adolescent, Adenocarcinoma, BTC (Bristol Trials Centre), 03 medical and health sciences, Young Adult, Double-Blind Method, oesophagectomy, medicine, HEB, Humans, Aged, Protocol (science), business.industry, ResearchInstitutes_Networks_Beacons/mcrc, General surgery, Cancer, medicine.disease, United Kingdom, Patient recruitment, Esophagectomy, quality of life, Laparoscopy, Surgery, Neoplasm Recurrence, Local, business, randomised controlled trial, 030217 neurology & neurosurgery, Follow-Up Studies |
| الوصف: | IntroductionSurgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life.Methods and analysisWe will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery.Ethics and disseminationThis study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal.Trial registration numberNCT10386621. |
| وصف الملف: | application/pdf; text; application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| تدمد: | 2044-6055 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::96fb67eff7ce30f29e410d8d266edd62Test https://pubmed.ncbi.nlm.nih.gov/31748296Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....96fb67eff7ce30f29e410d8d266edd62 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20446055 |
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