Dataset Information

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).

ABSTRACT:

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ISRCTN10386621.

SUBMITTER: Brierley RC

PROVIDER: S-EPMC6887040 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Publications

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).

Brierley Rachel C RC Gaunt Daisy D Metcalfe Chris C Blazeby Jane M JM Blencowe Natalie S NS Jepson Marcus M Berrisford Richard G RG Avery Kerry N L KNL Hollingworth William W Rice Caoimhe T CT Moure-Fernandez Aida A Wong Newton N Nicklin Joanna J Skilton Anni A Boddy Alex A Byrne James P JP Underwood Tim T Vohra Ravi R Catton James A JA Pursnani Kish K Melhado Rachel R Alkhaffaf Bilal B Krysztopik Richard R Lamb Peter P Culliford Lucy L Rogers Chris C Howes Benjamin B Chalmers Katy K Cousins Sian S Elliott Jackie J Donovan Jenny J Heys Rachael R Wickens Robin A RA Wilkerson Paul P Hollowood Andrew A Streets Christopher C Titcomb Dan D Humphreys Martyn Lee ML Wheatley Tim T Sanders Grant G Ariyarathenam Arun A Kelly Jamie J Noble Fergus F Couper Graeme G Skipworth Richard J E RJE Deans Chris C Ubhi Sukhbir S Williams Robert R Bowrey David D Exon David D Turner Paul P Daya Shetty Vinutha V Chaparala Ram R Akhtar Khurshid K Farooq Naheed N Parsons Simon L SL Welch Neil T NT Houlihan Rebecca J RJ Smith Joanne J Schranz Rachel R Rea Nicola N Cooke Jill J Williams Alexandra A Hindmarsh Carolyn C Maitland Sally S Howie Lucy L Barham Christopher Paul CP

BMJ open 20191119 11

<h4>Introduction</h4>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 Serv ...[more]

PMID: 31748296

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Project description:Background Oesophageal cancer is the eighth most common cause of cancer worldwide. In recent years, the frequency to use minimally invasive surgical methods for esophagectomy has been increased, but its real advantages over conventional surgery is still remains. The aim of this study is to compare patients who underwent open three-stage transthoracic oesophagectomy with those who underwent minimally invasive thoraco-laparoscopic oesophagectomy (MIO) to ascertain the feasibility, safety, and clinical advantages of the MIO. Methods We did a multicentre prospective, open and parallel, randomised controlled trial in six study centres between April 1st, 2014, and April 30th, 2018. Patients aged 18–75 years with resectable middle and upper esophageal cancer were randomly assigned via a computer-generated randomisation sequence to receive either open three-stage transthoracic oesophagectomy (Group A) or MIO (Group B). The perioperative outcomes were to compare operative time, intraoperative blood loss, total expenses in hospital, hospital stay, the number and location of lymph nodes harvested and respiratory complications within 30 days. This trial is registered with ClinicalTrials.gov Identifier: NCT02355249. Results We randomly assigned 339 patients to the Group A and 156 to the Group B. No differences emerged in terms of age (year) [(61.52±8.52) vs. (60.25±6.28), P=0.67], the median lengths of hospital stay (day) [(16.28±8.02) vs. (17.15±11.74), P=0.08]. Group A has less intraoperative blood loss (mL) [(241.1±165.8) vs. (274.0±169.8), P<0.05] and total expenses in hospital (?) [(92,076±27,889) vs. (107,669±32,655), P<0.05], shorter operative time (min) [(267±92.2) vs. (364.3±99.43), P<0.05]. While Group B has palpable advantage in the number [(18.30±11.44) vs. (23.08±12.45), P<0.05] and location [(4.30±2.16) vs. (5.44±2.37), P<0.05] of lymph nodes harvested. The proportion of respiratory complications within 30 days was no statistical difference in the Group B [21/156 (13.5%)] compared to the Group A [45/339 (13.3%)] (Chi-square sig =0.934, P>0.05). Meanwhile, the study makes clear that tumour size has no correlation to operative time (Spearman r =?0.014, P>0.05) and intraoperative blood loss (Spearman r =0.078, P>0.05). Conclusions Compared to open three-stage transthoracic oesophagectomy, MIO has prominent representation in lymph nodes harvested which is fatal to estimate prognosis and plan sequential treatment plan, although, MIO has some disadvantage such as longer operative time, more intraoperative blood loss and total expenses in hospital which is conflicting to previous observational studies conclusion. There is no statistical difference in respiratory complications within 30 days between the two surgical approaches. Next step, survival rate after 2 years will be analyzed and published after the follow-up work is finished.

Project description:IntroductionOesophageal cancer is the eighth most common cause of cancer worldwide. In 2009 in China, the incidence and death rate of oesophageal cancer was 22.14 per 100 000 person-years and 16.77 per 100 000 person-years, respectively, the highest in the world. Minimally invasive oesophagectomy (MIO) was introduced into clinical practice with the aim of reducing the morbidity rate. The mechanisms of MIO may lie in minimising the reaction to surgical injury and inflammation. There are some randomised trials regarding minimally invasive versus open oesophagectomy, with 100-850 subjects enrolled. To date, no large randomised controlled trial comparing minimally invasive versus open oesophagectomy has been reported in China, where squamous cell carcinoma predominated over adenocarcinoma of the oesophagus.Methods and analysisThis is a 3 year multicentre, prospective, randomised, open and parallel controlled trial, which aims to compare the effectiveness of minimally invasive thoraco-laparoscopic oesophagectomy to open three-stage transthoracic oesophagectomy for resectable oesophageal cancer. Group A patients receive MIO which involves thoracoscopic oesophagectomy and laparoscopic gastric mobilisation with cervical anastomosis. Group B patients receive the open three-stage transthoracic oesophagectomy which involves a right thoracotomy and laparotomy with cervical anastomosis. Primary endpoints include respiratory complications within 30 days after operation. The secondary endpoints include other postoperative complications, influences on pulmonary function, intraoperative data including blood loss, operative time, the number and location of lymph nodes dissected, and mortality in hospital, the length of hospital stay, total expenses in hospital, mortality within 30 days, survival rate after 2 years, postoperative pain, and health-related quality of life (HRQoL). Three hundred and twenty-four patients in each group will be needed and a total of 648 patients will finally be enrolled into the study.Ethics and disseminationThe study protocol has been approved by the Institutional Ethics Committees of all participating institutions. The findings of this trial will be disseminated to patients and through peer-reviewed publications and international presentations.Trial registration numberNCT02355249.

Dataset Information

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).

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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).

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