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

Trials

Jane M Blazeby¹  Tim Wheatley²  Dan R Titcomb¹  Christopher G Streets¹  Grant Sanders²  Sian Noble⁴  Richard Krysztopik⁵  Andrew A Hollowood¹  George Hanna⁶  Rob Goldin³  Stephen J Falk⁸  Jackie Elliott⁷  Jenny L Donovan⁴  C Paul Barham¹  Richard Berrisford²  Chris Metcalfe⁴  Kerry NL Avery⁴ 

[1] Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Marlborough Street, BS1 3NU Bristol, UK;Department of Upper Gastrointestinal Surgery, Derriford Hospital, Derriford Road, PL6 8DH Plymouth, UK;Centre for Pathology, 4th Floor Clarence Wing, St. Mary’s Hospital, Praed Street, W2 1NY London, UK;School of Social and Community Medicine, University of Bristol, 39 Whatley Road, BS8 2PS, Clifton Bristol, UK;Gastroenterology & Surgical Department B57, Royal United Hospital Bath NHS Trust, Combe Park, BA1 3NG Bath, UK;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;Gastro-Oesophageal Support and Help Group, 15 Honey Hill Road, BS15 4HG Kingswood, South Gloucestershire, UK;Bristol Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Horfield Road, BS2 8ED Bristol, UK

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

Others  :  805419
DOI  :  10.1186/1745-6215-15-200

 received in 2014-03-19, accepted in 2014-05-22,  发布年份 2014

【 摘 要 】

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; the ROMIO trial record at that site gives a link to the original version of the study protocol.

【 授权许可】

   
2014 Avery et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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