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: 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.

Costs of bariatric surgery in a randomised control trial (RCT) comparing Roux en Y gastric bypass vs sleeve gastrectomy in morbidly obese diabetic patients.

AIM: To provide a longitudinal analysis of the direct healthcare costs of providing laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery service in the context of a randomised control trial (RCT) of obese patients with type 2 diabetes in Waitemata District Health Board, Auckland, New Zealand. METHODS: The Waitemata District Health Board costing system was used to calculate costs in New Zealand Dollars (NZD) associated with all pre- and post-operative hospital clinic visits, peri-operative care, hospitalisations and medication costs up to one year after bariatric surgery. Healthcare costs of medications, laboratory investigations and hospital clinic visits for one year prior to enrolment into the RCT were also calculated. RESULTS: One hundred and fourteen patients were randomised to undergo laparoscopic sleeve gastrectomy (LSG, n=58) or laparoscopic Roux en Y gastric bypass (LRYGB, n=56). Total costs one year pre-enrolment was $203,926 for all patients (mean $1,789 per patient). Total cost of surgery was $1,208,005 (mean $9,131 per LSG patient and mean $12,456 per LRYGB patient). Total cost one year post-operatively was $542,656 (mean $4,760 per patient). The total medication cost reduced from $118,993.72(mean $1,044 per patient) to $31,304.93 (mean $274.60 per patient), p<0.005. The largest cost reduction was seen with annual diabetic medications reducing from $110,115.78(mean $965.93 per patient) to $7,237.85 (mean $63.48 per patient), p<0.005. CONCLUSIONS: Among patients with type 2 diabetes and morbid obesity undergoing LSG and LRYGB, health service costs were greater in the year after surgery than in the year before, although prescription costs were lower post-operatively. There was no significant difference in reduction in prescription cost by surgical procedure at 12 months. However, the LRYGB surgery was more expensive than LSG, primarily because of the longer operative time required.