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

Abstract

BackgroundThere 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/DesignA 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.DiscussionThe ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer.Trial registrationThe 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.

Minimally Invasive Versus Open Esophagectomy for Esophageal Cancer: A Population-Based Analysis

“…Although we attempted to control for known clinical, socioeconomic, hospital, and tumor covariates through our propensity-matched analysis, inherent differences between comparison groups may still occur that would be best addressed with a sufficiently powered randomized trial. For example, 2 different clinical trials in progress randomizing patients between OE and MIE are the French MIRO (Oesophagectomie Pour Cancer par Voie Conventionnelle ou Coelio-Assistée) trial [18] and the British ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) trial [19]. Nonetheless, our study is the largest comparative effectiveness study of MIE to date to examine long-term survival.…”

Multimodal Treatment for Cancer of the Esophagus

“…The three meta-analyses built on these randomized trials showed no diference in survival when the endpoint was 1-year survival in six of these trials. On the contrary, in comparison with surgical treatment, 2-year survival rates were improved following preoperative chemotherapy (4.4%) when the endpoint was 2-year survival in seven randomized trials [53]. When the meta-analysis was restricted to four recently randomized trials based on cisplatin and 5-luorouracil therapy, there was a 6.3% improvement in 2-year survival.…”

“…These limitations pave the way for the occurrence of unknown interactions and confounding variables. Currently, there are two diferent clinical trials comparing E to MIE patients, namely the French MIRO trial [52] and the British ROMIRO trail [53]. Still, the study that we conducted is the most extensive comparative efectiveness research of MIE assessing long-term survival.…”

Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design

“…These include development of a typology with which to deconstruct interventions into component parts (in order to consider which may need to be standardized), and qualitative data collection in the operating room (in order to understand how interventions are actually delivered and explore surgeons' views about standardization). 42 The methods are currently being tested and refined within an RCT 34 and observational study, 43 to explore how the interventions might be described and standardized across different research settings.…”

“…Case study 2 Achieving blinding of patients: the ROMIO study 34,46 Background Surgery alone or in combination with chemotherapy or chemoradiation treatment is the mainstay of cure for localized esophageal cancer. There are several surgical approaches, and the past decade has seen a growing interest in minimal access surgical techniques with the potential advantages of causing less tissue trauma and better recovery.…”