The feasibility of a randomised controlled trial of minimally invasive and open surgery for oesophageal cancer

There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of oesophageal cancer, but randomised controlled trials in surgery are often difficult to conduct. The ROMIO (Randomised 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 oesophageal cancer.

Methods:
A pilot randomised controlled trial (RCT), in two centres (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 oesophagectomy by, i) open gastric mobilisation and right thoracotomy, ii) laparoscopic gastric mobilisation and right thoracotomy and iii) in the Bristol centre only, totally minimally invasive surgery. 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 oesophageal 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.DiscussionThe ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for oesophageal cancer.Trial registration: The pilot trial has Current Controlled Trials registration number ISRCTN59036820 (25/02/2013) at www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol.

Author: Kerry NL AveryChris MetcalfeRichard BerrisfordC Paul BarhamJenny L DonovanJackie ElliottStephen J FalkRob GoldinGeorge HannaAndrew A HollowoodRichard KrysztopikSian NobleGrant SandersChristopher G StreetsDan R TitcombTim WheatleyJane M Blazeby

Published on: 2014-06-02

News Provider: 7thSpace Interactive

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