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Open Access Study protocol

The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

Kerry NL Avery1, Chris Metcalfe1, Richard Berrisford2, C Paul Barham3, Jenny L Donovan1, Jackie Elliott4, Stephen J Falk5, Rob Goldin6, George Hanna7, Andrew A Hollowood3, Richard Krysztopik8, Sian Noble1, Grant Sanders2, Christopher G Streets3, Dan R Titcomb3, Tim Wheatley2 and Jane M Blazeby13*

Author Affiliations

1 School of Social and Community Medicine, University of Bristol, 39 Whatley Road, BS8 2PS, Clifton Bristol, UK

2 Department of Upper Gastrointestinal Surgery, Derriford Hospital, Derriford Road, PL6 8DH Plymouth, UK

3 Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Marlborough Street, BS1 3NU Bristol, UK

4 Gastro-Oesophageal Support and Help Group, 15 Honey Hill Road, BS15 4HG Kingswood, South Gloucestershire, UK

5 Bristol Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Horfield Road, BS2 8ED Bristol, UK

6 Centre for Pathology, 4th Floor Clarence Wing, St. Mary’s Hospital, Praed Street, W2 1NY London, UK

7 Department of Bio-Surgery & Surgical Technology, Imperial College NHS Trust, Academic Surgical Unit, 10th Floor, QEQM Building, St. Mary’s Hospital, Praed Street, W2 1NY London, UK

8 Gastroenterology & Surgical Department B57, Royal United Hospital Bath NHS Trust, Combe Park, BA1 3NG Bath, UK

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Trials 2014, 15:200  doi:10.1186/1745-6215-15-200

Published: 2 June 2014

Abstract

Background

There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer.

Methods/Design

A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff.

Discussion

The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer.

Trial registration

The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com webcite; the ROMIO trial record at that site gives a link to the original version of the study protocol.

Keywords:
Feasibility studies; Upper gastrointestinal neoplasms; Pilot study; Surgical procedures; Minimally invasive; Randomized controlled trial