{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T08:41:43Z","timestamp":1768984903183,"version":"3.49.0"},"reference-count":59,"publisher":"National Institute for Health and Care Research","issue":"48","license":[{"start":{"date-parts":[[2016,6,1]],"date-time":"2016-06-01T00:00:00Z","timestamp":1464739200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["10\/50\/65"],"award-info":[{"award-number":["10\/50\/65"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title><jats:p>Localised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6\u20139 months. Minimal-access surgery may accelerate recovery.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objectives<\/jats:title><jats:p>The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title><jats:p>Pilot parallel three-arm randomised controlled trial nested within feasibility work.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title><jats:p>Two UK NHS departments of upper gastrointestinal surgery.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title><jats:p>Patients aged \u2265\u200918 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title><jats:p>Oesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Main outcome measure<\/jats:title><jats:p>The primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title><jats:p>During 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the hybrid procedure and 20 to totally minimally invasive surgery. Recruitment is continuing, allowing a seamless transition into the definitive trial. Consequently, the database is unlocked at the time of writing and data presented here are for patients recruited by 31 August 2014. Random allocation achieved a good balance between the arms of the study, which, as a high proportion of patients underwent their allocated surgery (69\/79, 87%), ensured a fair comparison between the interventions. Dressing patients with large bandages, covering all possible incisions, was successful in keeping patients blind while pain was assessed during the first week post surgery. Postsurgical length of stay and risk of adverse events were within the typical range for this group of patients, with one death occurring within 30 days among 76 patients. There were good completion rates for the assessment of pain at 6 days post surgery (88%) and of the patient-reported outcomes at 6 weeks post randomisation (74%).<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Conclusions<\/jats:title><jats:p>Rapid recruitment to the pilot trial and the successful refinement of methodology indicated the feasibility of a definitive trial comparing different approaches to oesophagectomy. Although we have shown a full trial of open compared with minimally invasive oesophagectomy to be feasible, this is necessarily based on our findings from the two clinical centres that we could include in this small preliminary study.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-10\"><jats:title>Trial registration<\/jats:title><jats:p>Current Controlled Trials ISRCTN59036820.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-11\"><jats:title>Funding<\/jats:title><jats:p>This project was funded by the NIHR Health Technology Assessment programme and will be published in full in<jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 20, No. 48. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta20480","type":"journal-article","created":{"date-parts":[[2016,7,1]],"date-time":"2016-07-01T08:32:29Z","timestamp":1467361949000},"page":"1-68","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":34,"title":["Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial"],"prefix":"10.3310","volume":"20","clinical-trial-number":[{"clinical-trial-number":"isrctn59036820","registry":"10.18810\/isrctn","type":"results"}],"author":[{"given":"Chris","family":"Metcalfe","sequence":"first","affiliation":[{"name":"Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK"},{"name":"School of Social and Community Medicine, University of Bristol, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kerry","family":"Avery","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine, University of Bristol, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Berrisford","sequence":"additional","affiliation":[{"name":"Department of Upper Gastrointestinal Surgery, Plymouth Hospitals NHS Trust, Plymouth, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Barham","sequence":"additional","affiliation":[{"name":"Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sian M","family":"Noble","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine, University of Bristol, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aida Moure","family":"Fernandez","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine, University of Bristol, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George","family":"Hanna","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Goldin","sequence":"additional","affiliation":[{"name":"Department of Cellular Pathology, Imperial College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jackie","family":"Elliott","sequence":"additional","affiliation":[{"name":"Gastro-Oesophageal Support and Help Group, Kingswood, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy","family":"Wheatley","sequence":"additional","affiliation":[{"name":"Department of Upper Gastrointestinal Surgery, Plymouth Hospitals NHS Trust, Plymouth, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Grant","family":"Sanders","sequence":"additional","affiliation":[{"name":"Department of Upper Gastrointestinal Surgery, Plymouth Hospitals NHS Trust, Plymouth, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Hollowood","sequence":"additional","affiliation":[{"name":"Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Falk","sequence":"additional","affiliation":[{"name":"Bristol Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan","family":"Titcomb","sequence":"additional","affiliation":[{"name":"Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Streets","sequence":"additional","affiliation":[{"name":"Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jenny L","family":"Donovan","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine, University of Bristol, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane M","family":"Blazeby","sequence":"additional","affiliation":[{"name":"School of Social and Community Medicine, University of Bristol, Bristol, UK"},{"name":"Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"6221","published-online":{"date-parts":[[2016,6]]},"reference":[{"key":"key20160630152011235_ref1-bib1","volume-title":"Oesophageal Cancer Incidence Statistics","author":"Cancer Research UK"},{"key":"key20160630152011235_ref1-bib2","volume-title":"National Oesophago-Gastric Cancer Audit 2012","author":"Groene","year":"2012"},{"key":"key20160630152011235_ref1-bib3","doi-asserted-by":"crossref","first-page":"297","DOI":"10.1503\/cjs.005512","article-title":"Laparoscopic versus open surgery for the treatment of colorectal cancer: a literature review and recommendations from the Comit\u00e9 de l\u2019\u00e9volution des pratiques en oncologie","volume":"56","author":"Morneau","year":"2013","journal-title":"Can J Surg"},{"key":"key20160630152011235_ref1-bib4","doi-asserted-by":"publisher","first-page":"658","DOI":"10.1097\/SLA.0b013e3182480a6a","article-title":"Reporting of short-term clinical outcomes after oesophagectomy: a systematic review","volume":"255","author":"Blencowe","year":"2012","journal-title":"Ann Surg"},{"key":"key20160630152011235_ref1-bib5","doi-asserted-by":"publisher","first-page":"1461","DOI":"10.1002\/bjs.6015","article-title":"Systematic review of minimally invasive resection for gastro-oesophageal cancer","volume":"94","author":"Gemmill","year":"2007","journal-title":"Br J Surg"},{"key":"key20160630152011235_ref1-bib6","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1016\/j.ejcts.2008.09.024","article-title":"Minimally invasive esophagectomy for cancer","volume":"35","author":"Decker","year":"2009","journal-title":"Eur J Cardiothorac Surg"},{"key":"key20160630152011235_ref1-bib7","first-page":"135","article-title":"Minimally invasive surgery compared to open procedures in esophagectomy for cancer: a systematic review of the literature","volume":"64","author":"Verhage","year":"2009","journal-title":"Minerva Chir"},{"key":"key20160630152011235_ref1-bib8","doi-asserted-by":"publisher","first-page":"486","DOI":"10.1097\/01.sla.0000089858.40725.68","article-title":"Minimally invasive esophagectomy: outcomes in 222 patients","volume":"238","author":"Luketich","year":"2003","journal-title":"Ann Surg"},{"key":"key20160630152011235_ref1-bib9","doi-asserted-by":"publisher","first-page":"232","DOI":"10.1097\/01.sla.0000225093.58071.c6","article-title":"Comparison of the outcomes between open and minimally invasive esophagectomy","volume":"245","author":"Smithers","year":"2007","journal-title":"Ann Surg"},{"key":"key20160630152011235_ref1-bib10","doi-asserted-by":"publisher","first-page":"894","DOI":"10.1097\/SLA.0b013e3182263781","article-title":"Transthoracic versus transhiatal esophagectomy for the treatment of esophagogastric cancer: a meta-analysis","volume":"254","author":"Boshier","year":"2011","journal-title":"Ann Surg"},{"key":"key20160630152011235_ref1-bib11","doi-asserted-by":"publisher","first-page":"525","DOI":"10.1002\/bjs.6908","article-title":"Health-related quality of life after minimally invasive oesophagectomy","volume":"97","author":"Parameswaran","year":"2010","journal-title":"Br J Surg"},{"key":"key20160630152011235_ref1-bib12","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1097\/SLA.0b013e3181b13ca2","article-title":"The Clavien-Dindo Classification of Surgical Complications. Five-year experience","volume":"250","author":"Clavien","year":"2009","journal-title":"Ann Surg"},{"key":"key20160630152011235_ref1-bib13","doi-asserted-by":"crossref","DOI":"10.1200\/jco.2015.33.3_suppl.5","article-title":"Hybrid minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicenter, open-label, randomized Phase III controlled trial, the MIRO trial","volume":"33","author":"Mariette","year":"2015","journal-title":"J Clin Oncol"},{"key":"key20160630152011235_ref1-bib14","doi-asserted-by":"crossref","first-page":"310","DOI":"10.1186\/1471-2407-11-310","article-title":"Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial \u2013 the MIRO trial","volume":"11","author":"Briez","year":"2011","journal-title":"BMC Cancer"},{"key":"key20160630152011235_ref1-bib15","doi-asserted-by":"publisher","first-page":"1887","DOI":"10.1016\/S0140-6736(12)60516-9","article-title":"Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multi-centre, open-label, randomised controlled trial","volume":"379","author":"Biere","year":"2012","journal-title":"Lancet"},{"key":"key20160630152011235_ref1-bib16","doi-asserted-by":"crossref","first-page":"473","DOI":"10.1097\/00005650-199206000-00002","article-title":"The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection","volume":"30","author":"Ware","year":"1992","journal-title":"Med Care"},{"key":"key20160630152011235_ref1-bib17","doi-asserted-by":"publisher","first-page":"1384","DOI":"10.1016\/S0959-8049(03)00270-3","article-title":"Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer","volume":"39","author":"Blazeby","year":"2003","journal-title":"Eur J Cancer"},{"key":"key20160630152011235_ref1-bib18","doi-asserted-by":"publisher","first-page":"1105","DOI":"10.1016\/S0140-6736(09)61116-8","article-title":"No surgical innovation without evaluation: the IDEAL recommendations","volume":"374","author":"McCulloch","year":"2009","journal-title":"Lancet"},{"key":"key20160630152011235_ref1-bib19","doi-asserted-by":"crossref","first-page":"404","DOI":"10.1093\/biomet\/26.4.404","article-title":"The use of confidence of fiducial limits illustrated in the case of the binomial","volume":"26","author":"Clopper","year":"1934","journal-title":"Biometrika"},{"key":"key20160630152011235_ref1-bib20","doi-asserted-by":"publisher","first-page":"143","DOI":"10.1016\/j.cct.2003.10.016","article-title":"Assessment of blinding in clinical trials","volume":"25","author":"Bang","year":"2004","journal-title":"Control Clin Trials"},{"key":"key20160630152011235_ref1-bib21","doi-asserted-by":"publisher","first-page":"365","DOI":"10.1093\/jnci\/85.5.365","article-title":"The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology","volume":"85","author":"Aaronson","year":"1993","journal-title":"J Natl Cancer Inst"},{"key":"key20160630152011235_ref1-bib22","doi-asserted-by":"publisher","first-page":"241","DOI":"10.1038\/bjc.1996.42","article-title":"Application of the Multidimensional Fatigue Inventory (MFI-20) in cancer patients receiving radiotherapy","volume":"73","author":"Smets","year":"1996","journal-title":"Br J Cancer"},{"key":"key20160630152011235_ref1-bib23","doi-asserted-by":"publisher","first-page":"205","DOI":"10.1097\/01.sla.0000133083.54934.ae","article-title":"Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey","volume":"240","author":"Dindo","year":"2004","journal-title":"Ann Surg"},{"key":"key20160630152011235_ref1-bib24","volume-title":"EQ-5D-5L","author":"The EuroQol Group"},{"key":"key20160630152011235_ref1-bib25","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1007\/978-0-387-88441-7_10","volume-title":"AJCC Cancer Staging Manual","author":"American Joint Committee on Cancer","year":"2010","edition":"7th edn"},{"key":"key20160630152011235_ref1-bib26","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/1745-6215-10-9","article-title":"The challenges faced in the design, conduct and analysis of surgical randomised controlled trials","volume":"10","author":"Cook","year":"2009","journal-title":"Trials"},{"key":"key20160630152011235_ref1-bib27","doi-asserted-by":"publisher","first-page":"200","DOI":"10.1186\/1745-6215-15-200","article-title":"The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer \u2013 the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial","volume":"15","author":"Avery","year":"2014","journal-title":"Trials"},{"key":"key20160630152011235_ref1-bib28","doi-asserted-by":"publisher","first-page":"663","DOI":"10.1016\/j.cct.2008.03.003","article-title":"Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations","volume":"29","author":"de Salis","year":"2008","journal-title":"Contemp Clin Trials"},{"key":"key20160630152011235_ref1-bib29","doi-asserted-by":"publisher","first-page":"78","DOI":"10.1186\/1745-6215-12-78","article-title":"Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK\/07\/011)","volume":"12","author":"Paramasivan","year":"2011","journal-title":"Trials"},{"key":"key20160630152011235_ref1-bib30","doi-asserted-by":"publisher","first-page":"2333","DOI":"10.1007\/s00405-013-2349-8","article-title":"The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer","volume":"270","author":"Hamilton","year":"2013","journal-title":"Eur Arch Otorhinolaryngol"},{"key":"key20160630152011235_ref1-bib31","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1016\/j.cct.2008.07.007","article-title":"Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness","volume":"30","author":"Howard","year":"2009","journal-title":"Contemp Clin Trials"},{"key":"key20160630152011235_ref1-bib32","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1016\/j.jclinepi.2008.02.010","article-title":"Development of a complex intervention improved randomisation and informed consent in a randomized controlled trial","volume":"62","author":"Donovan","year":"2009","journal-title":"J Clin Epidemiol"},{"key":"key20160630152011235_ref1-bib33","first-page":"515","volume-title":"Handbook of Health Research Methods","author":"Donovan","year":"2005"},{"key":"key20160630152011235_ref1-bib34","doi-asserted-by":"publisher","first-page":"766","DOI":"10.1136\/bmj.325.7367.766","article-title":"Improving the design and conduct of randomised trials: the role of qualitative research methods in the ProtecT study","volume":"325","author":"Donovan","year":"2002","journal-title":"BMJ"},{"key":"key20160630152011235_ref1-bib35","volume-title":"Qualitative Data Analysis","author":"Miles","year":"1994","edition":"2nd edn."},{"key":"key20160630152011235_ref1-bib36","volume-title":"Designing Qualitative Research","author":"Marshall","year":"1995"},{"key":"key20160630152011235_ref1-bib37","volume-title":"An Introduction to Qualitative Research","author":"Flick","year":"2009"},{"key":"key20160630152011235_ref1-bib38","doi-asserted-by":"publisher","first-page":"107","DOI":"10.1007\/s00464-007-9380-z","article-title":"Contructing hierarchical task analysis in surgery","volume":"22","author":"Sarker","year":"2008","journal-title":"Surg Endosc"},{"key":"key20160630152011235_ref1-bib39","doi-asserted-by":"publisher","first-page":"251","DOI":"10.1016\/j.amjsurg.2010.01.031","article-title":"Development of an objective evaluation tool to assess technical skills in laparoscopic colorectal surgery: a Delphi methodology","volume":"201","author":"Palter","year":"2011","journal-title":"Am J Surg"},{"key":"key20160630152011235_ref1-bib40","doi-asserted-by":"publisher","first-page":"i50","DOI":"10.1136\/qshc.2005.015842","article-title":"Work system design for patient safety: the SEIPS model","volume":"15","author":"Carayon","year":"2006","journal-title":"Qual Saf Health Care"},{"key":"key20160630152011235_ref1-bib41","doi-asserted-by":"publisher","first-page":"476","DOI":"10.1097\/SLA.0b013e318275b72a","article-title":"Is competency assessment at the specialist level achievable? A study for the national training programme in laparoscopic colorectal surgery in England","volume":"257","author":"Miskovic","year":"2013","journal-title":"Ann Surg"},{"key":"key20160630152011235_ref1-bib42","doi-asserted-by":"publisher","first-page":"38","DOI":"10.1186\/1745-6215-8-38","article-title":"OMERACT: an international initiative to improve outcome measurement in rheumatology","volume":"8","author":"Tugwell","year":"2007","journal-title":"Trials"},{"key":"key20160630152011235_ref1-bib43","volume-title":"COMET","author":"North West Hub for Trials Methodology Research"},{"key":"key20160630152011235_ref1-bib44","volume-title":"Exacta Medica","author":"Entwistle","year":"2003"},{"key":"key20160630152011235_ref1-bib45","volume-title":"Dataset for the Histopathological Reporting of Oesophageal Carcinoma","author":"Mapstone","year":"2007","edition":"2nd edition"},{"key":"key20160630152011235_ref1-bib46","doi-asserted-by":"publisher","first-page":"195","DOI":"10.1016\/j.jval.2012.09.008","article-title":"Using resource use logs to reduce the amount of missing data in economic evaluations alongside trials","volume":"16","author":"Marques","year":"2013","journal-title":"Value Health"},{"key":"key20160630152011235_ref1-bib47","doi-asserted-by":"publisher","first-page":"912","DOI":"10.1016\/j.jclinepi.2014.03.010","article-title":"The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials","volume":"67","author":"Donovan","year":"2014","journal-title":"J Clin Epidemiol"},{"key":"key20160630152011235_ref1-bib48","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/1745-6215-15-5","article-title":"Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials","volume":"15","author":"Donovan","year":"2014","journal-title":"Trials"},{"key":"key20160630152011235_ref1-bib49","doi-asserted-by":"publisher","first-page":"1713","DOI":"10.1200\/JCO.2010.28.0107","article-title":"Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30","volume":"48","author":"Cocks","year":"2010","journal-title":"J Clin Oncol"},{"key":"key20160630152011235_ref1-bib50","doi-asserted-by":"publisher","first-page":"547","DOI":"10.1016\/S0197-2456(99)00032-X","article-title":"Sample-size calculation for a log-transformed outcome measure","volume":"20","author":"Wolfe","year":"1999","journal-title":"Control Clin Trials"},{"key":"key20160630152011235_ref1-bib51","doi-asserted-by":"publisher","first-page":"CD003432","DOI":"10.1002\/14651858.cd003432.pub2","article-title":"Long-term results of laparoscopic colorectal cancer resection","volume":"16","author":"Kuhry","year":"2008","journal-title":"Cochrane Database Syst Rev"},{"key":"key20160630152011235_ref1-bib52","doi-asserted-by":"publisher","first-page":"1111","DOI":"10.1002\/bjs.4640","article-title":"Meta-analysis of short-term outcomes after laparoscopic resection for colorectal cancer","volume":"91","author":"Abraham","year":"2004","journal-title":"Br J Surg"},{"key":"key20160630152011235_ref1-bib53","doi-asserted-by":"publisher","first-page":"CD005200","DOI":"10.1002\/14651858.CD005200.pub3","article-title":"Laparoscipic versus open total mesorectal excision for rectal cancer","volume":"15","author":"Vennix","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"key20160630152011235_ref1-bib54","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1258\/jhsrp.2011.011031","article-title":"Failure mode and effects analysis: views of hospital staff in the UK","volume":"17","author":"Shebl","year":"2012","journal-title":"J Health Serv Res Policy"},{"key":"key20160630152011235_ref1-bib55","doi-asserted-by":"publisher","first-page":"1804","DOI":"10.1200\/JCO.2013.54.3694","article-title":"A multicentre randomised controlled trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme (EnROL)","volume":"32","author":"Kennedy","year":"2014","journal-title":"J Clin Oncol"},{"key":"key20160630152011235_ref1-bib56","volume-title":"NHS Reference Costs","author":"Department of Health"},{"key":"key20160630152011235_ref1-bib57","volume-title":"Unit Costs of Health and Social Care","author":"Curtis","year":"2014"},{"key":"key20160630152011235_ref1-bib58","volume-title":"British National Formulary","author":"Joint Formulary Committee","year":"2014","edition":"68 ed."},{"key":"key20160630152011235_ref1-bib59","volume-title":"Guide to the Methods of Technology Appraisal","author":"National Institute for Health and Care Excellence (NICE)","year":"2004"}],"container-title":["Health Technology Assessment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta20480\/hta20480.xml","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2002510","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta20480\/hta20480.xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2003429","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T15:48:36Z","timestamp":1692114516000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/hta\/hta20480\/"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,6]]},"references-count":59,"journal-issue":{"issue":"48","published-online":{"date-parts":[[2016,6]]}},"alternative-id":["10.3310\/hta20480"],"URL":"https:\/\/doi.org\/10.3310\/hta20480","relation":{},"ISSN":["1366-5278","2046-4924"],"issn-type":[{"value":"1366-5278","type":"print"},{"value":"2046-4924","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,6]]},"assertion":[{"value":"This content has been made freely available to all.","name":"free","label":"Free to read"}]}}