Comparing open and minimally invasive surgical procedures for esophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial

Metcalfe C, Avery K, Berrisford R, Barham P, Noble SM, Fernandez AM, Hanna G, Goldin R, Elliott J, Wheatley T, Sanders G, Hollowood A, Falk S, Titcomb D, Streets C, Donovan JL, Blazeby JM
Record ID 32013001003
English
Authors' objectives: 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.
Authors' recommendations: 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.
Details
Project Status: Completed
URL for project: http://www.nets.nihr.ac.uk/projects/hta/105065
Year Published: 2016
URL for published report: http://www.journalslibrary.nihr.ac.uk/hta/hta20480/#/abstract
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Conversion to Open Surgery
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
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