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.

Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study.

INTRODUCTION: Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in 'real world' settings), compared with explanatory trials (which are smaller and more tightly controlled). OBJECTIVE: This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT. METHODS AND ANALYSIS: We have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity. ETHICS AND DISSEMINATION: Ethics approval was obtained (NRES Committee South West-Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN59036820, ISRCTN10386621.

Predicting blood transfusion in patients undergoing minimally invasive oesophagectomy.

AIM: To evaluate predictors of allogenic blood transfusion requirements in patients undergoing minimal invasive oesophagectomy at a tertiary high volume centre for oesophago-gastric surgery. METHODS: Retrospective analysis of all patients undergoing minimal access oesophagectomy in our department between January 2010 and December 2011. Patients were divided into two groups depending on whether they required a blood transfusion at any time during their index admission. Factors that have been shown to influence perioperative blood transfusion requirements in major surgery were included in the analysis. Binary logistic regression analysis was performed to determine the impact of patient and perioperative characteristics on transfusion requirements during the index admission. RESULTS: A total of 80 patients underwent minimal access oesophagectomy, of which 61 patients had a laparoscopic assisted oesophagectomy and 19 patients had a minimal invasive oesophagectomy. Perioperative blood transfusion was required in 28 patients at any time during hospital admission. On binary logistic regression analysis, a lower preoperative haemoglobin concentration (p < 0.01), suffering a significant complication (p < 0.005) and laparoscopic assisted oesophagectomy (p < 0.05) were independent predictors of blood transfusion requirements. DISCUSSION: It has been reported that requirement for blood transfusion can affect long-term outcomes in oesophageal cancer resection. Two factors which could be addressed preoperatively; haemoglobin concentration and type of oesophageal resection, may be valuable in predicting blood transfusions in patients undergoing minimally invasive oesophagectomy. CONCLUSION: Our analysis revealed that preoperative haemoglobin concentration, occurrence of significant complications and type of minimal access oesophagectomy predicted blood transfusion requirements in the patient population examined.

Quantifying potential error in painting breast excision specimens.

Aim. When excision margins are close or involved following breast conserving surgery, many surgeons will attempt to reexcise the corresponding cavity margin. Margins are ascribed to breast specimens such that six faces are identifiable to the pathologist, a process that may be prone to error at several stages. Methods. An experimental model was designed according to stated criteria in order to answer the research question. Computer software was used to measure the surface areas of experimental surfaces to compare human-painted surfaces with experimental controls. Results. The variability of the hand-painted surfaces was considerable. Thirty percent of hand-painted surfaces were 20% larger or smaller than controls. The mean area of the last surface painted was significantly larger than controls (mean 58996 pixels versus 50096 pixels, CI 1477-16324, P = 0.014). By chance, each of the six volunteers chose to paint the deep surface last. Conclusion. This study is the first to attempt to quantify the extent of human error in marking imaginary boundaries on a breast excision model and suggests that humans do not make these judgements well, raising questions about the safety of targeting single margins at reexcision.

Assessment of the relationship between post-meal satiety, gastric volume and gastric emptying after swedish adjustable gastric banding. A pilot study using magnetic resonance imaging to assess postsurgery gastric function.

BACKGROUND: Swedish adjustable gastric banding (SAGB) is a common weight loss procedure performed worldwide. The exact mechanism by which it achieves appetite suppression, and hence weight loss, is not clear. One possible mechanism is altered meal handling by the post-SAGB stomach. METHODS: Five post SAGB patients and five age/sex-matched controls were recruited. Pre- and post-meal magnetic resonance imaging (MRI) was performed with two liquid test meals of differing viscosity-locust bean gum (3.0%) and water. Appetite was assessed using ten-point visual analogue scales. RESULTS: There were significant relationships between hunger scores and esophageal, pouch and residual stomach fluid volume changes for the locust bean gum meal (p=0.033, 0.043 and 0.011, respectively). The rate constants for gastric emptying were similar in the two groups for both the gum (0.038+/-0.016 min(-1) for SAGB, 0.041+/-0.032 min(-1) for controls, p=0.44) and water meals (0.068+/-0.044 min(-1) for SAGB, 0.044+/-0.009 min(-1) for controls, p=0.35). An unexpected finding was asymptomatic esophageal meal retention with the locust bean gum meal in the post-SAGB arm (mean 16.9 ml at 15 min). CONCLUSIONS: There is no evidence of differences in volume-dependent gastric emptying between the normal and post-SAGB stomach. Further investigation of the phenomenon of esophageal retention, and its role in post-SAGB satiety, is warranted.

Effect of n-3 polyunsaturated fatty acids on Barrett's epithelium in the human lower esophagus.

BACKGROUND: Epidemiologic studies suggest a reduced risk of esophageal adenocarcinoma in populations with a high consumption of fish, and n-3 fatty acids inhibit experimental carcinogenesis. One possible explanation is the suppression of eicosanoid production through inhibition of cyclooxygenase 2 (COX-2). OBJECTIVE: The objective was to determine the effects of dietary supplementation with the n-3 fatty acid eicosapentaenoic acid (EPA) on a number of biological endpoints in Barrett's esophagus. DESIGN: Fifty-two participants with known Barrett's esophagus underwent endoscopy. Biopsy samples were obtained from a recorded level within the area of Barrett's esophagus, and then 27 patients were randomly assigned to consume EPA capsules (1.5 g/d) for 6 mo or no supplement (controls). At the end of this period, patients again underwent endoscopy, and biopsy samples were collected at the same level. Tissue samples were analyzed for mucosal lipid, prostaglandin E2, leukotriene B4, COX-2 protein, and RNA concentrations. Cellular proliferation was also measured, by Ki-67 immunohistochemistry. RESULTS: The EPA content of esophageal mucosa increased over the study period in the n-3-supplemented subjects and was significantly different from the content in the controls (P < 0.01). There was also a significant decline in COX-2 protein concentrations (measured by immunoblotting) in the n-3 group, and the difference was significant from that in the controls (P < 0.05); no difference in COX-2 RNA concentrations was observed between groups. This change in COX-2 protein was inversely related to the change in EPA content (P < 0.05). There was no significant difference in the change in prostaglandin E2, leukotriene B4, or cellular proliferation between the 2 groups. CONCLUSION: Supplementation with EPA significantly changed n-3 fatty acid concentrations and reduced COX-2 concentrations in Barrett's tissue.

Choice of approach for appendicectomy: a meta-analysis of open versus laparoscopic appendicectomy.

Although laparoscopic appendicectomy has been performed since 1983, the optimal approach for appendicectomy is still under debate. A systematic review and meta-analysis of all randomized controlled trials between 1995 and 2006 was undertaken. Studies were analyzed overall and in 2 subgroups (pre-2000 and post-2000) to examine for changes in outcomes with increased laparoscopic experience. Operation time was significantly longer for laparoscopy and hospital stay was shorter. Operating time reduced markedly for laparoscopy on subgroup analysis. The risks of postoperative ileus and wound infection are lower for laparoscopy. Perhaps paradoxically, the risk of intra-abdominal abscess development is significantly raised with laparoscopy with an odds ratio of 2.26 (P=0.0002). Laparoscopic appendicectomy is a safe and effective method of treating acute appendicitis. This meta-analysis shows improvement in the outcomes of laparoscopy with increasing laparoscopic experience but open surgery appears to still confer benefits, especially in terms of intra-abdominal abscess incidence.

Review of outcome after laparoscopic paraesophageal hiatal hernia repair.

Many studies have confirmed the effectiveness of laparoscopic paraesophageal hernia repair, but there are reports of high recurrence rates after surgery. We have conducted a review of the literature to determine whether it is a safe and durable procedure. A literature search was performed to identify all papers relevant to laparoscopic paraesophageal hernia repair. Twenty studies met the inclusion criteria for this review. In total, 1415 patients underwent attempted repair (mean age 65.7 y) of which 94% underwent an antireflux procedure. There were 70 (5.3%) episodes of operative morbidity and 173 (12.7%) patients experienced postoperative complications. In 10 studies, radiologic follow-up was offered after a mean of 16.5 months. Of those undergoing contrast swallow 26.9% had evidence of anatomic recurrence. In conclusion, recurrence rates after laparoscopic repair seem to be high compared with earlier studies of open repair. The long-term consequences of anatomic recurrence are currently uncertain.

A radiological study of the intraprosthetic movements of the bipolar shoulder replacement in rheumatoid arthritis.

A radiological study of the intraprosthetic movements of a bipolar shoulder replacement was undertaken in 25 shoulders in 20 patients with rheumatoid arthritis and rotator cuff arthropathy. No significant difference was found between intraprosthetic movement and shell - glenoid movement. Some shoulders were found to exhibit paradoxical movement at the intraprosthetic interface. Repeating the measurements after an interval of three years in a subgroup of 12 shoulders showed a significant reduction in intraprosthetic movement over this time interval. In conclusion, movement of the bipolar shoulder prosthesis in shoulders affected by rheumatoid arthritis was preserved up to eight years from operation. Intraprosthetic movement was independent from shell - glenoid movement and paradoxical to glenohumeral movement.