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).
Adenocarcinoma
/ economics
Adolescent
Adult
Aged
Aged, 80 and over
Carcinoma, Squamous Cell
/ economics
Clinical Protocols
Cost-Benefit Analysis
Double-Blind Method
Esophageal Neoplasms
/ economics
Esophagectomy
/ economics
Female
Follow-Up Studies
Humans
Laparoscopy
/ economics
Male
Middle Aged
Neoplasm Recurrence, Local
/ economics
Postoperative Complications
/ economics
Quality of Life
Regression Analysis
Treatment Outcome
United Kingdom
/ epidemiology
Young Adult
minimally invasive oesophagectomy
oesophageal cancer
oesophagectomy
quality of life
randomised controlled trial
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
19 11 2019
19 11 2019
Historique:
entrez:
22
11
2019
pubmed:
22
11
2019
medline:
27
10
2020
Statut:
epublish
Résumé
Surgery (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. We 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. This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal. ISRCTN10386621.
Identifiants
pubmed: 31748296
pii: bmjopen-2019-030907
doi: 10.1136/bmjopen-2019-030907
pmc: PMC6887040
doi:
Banques de données
ISRCTN
['ISRCTN10386621']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e030907Subventions
Organisme : Cancer Research UK
ID : 23924
Pays : United Kingdom
Organisme : Department of Health
ID : HTA/14/140/78
Pays : United Kingdom
Organisme : Department of Health
ID : 14/140/78
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/K025643/1
Pays : United Kingdom
Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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