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BACKGROUND Clinical decision making is a core competency of surgical practice, involving a continuous and evolving process of data interpretation and evaluation. The aim of this article is twofold. First, to recognize patient deaths where a clinical incident arose following unsatisfactory clinical decision making, determining where in the clinical decision-making process each failure occurred. Second, to discuss and explore individual incidents to provide lessons from which the surgical community can learn. METHODS Using the Australian and New Zealand Audit of Surgical Mortality database, all deaths from 1 January 2015 to 31 December 2015 were analysed. All deaths in which the surgeon or assessor identified an aspect of patient management that was inadequate were recognized. Clinical incidents deemed by the assessor to be an area of concern or an adverse event were individually reviewed to determine if a clinical decision-making incident (CDMI) occurred. CDMIs were categorized into various themes depending on the nature of the incident. RESULTS A total of 3422 fully audited deaths occurred throughout the study period; from these cases, 226 individual CDMIs were identified. Decision to operate was the most commonly identified CDMI (n = 99, 43.8%), followed by diagnostic error (n = 49, 21.7%). The least common CDMI identified was inadequate post-operative assessment (n = 14, 6.2%). CONCLUSION This paper demonstrates thought-provoking examples of clinical decision-making failure implicated in patient death. Clinical decision-making failures most commonly occur around the decision to operate with increased discussion of complex cases possibly required. Further CDMI evaluation should be considered to complement more traditional methods of surgical mortality evaluation.

AIM To analyse the safety and efficacy of curative intent surgery in biliary and pancreatic cancer. METHODS An extensive literature review was performed using MEDLINE, Google Scholar and EMBASE to identify articles regarding hepato-pancreatoduodenectomy or resection of liver metastasis in patients with pancreatic, biliary tract, periampullary and gallbladder cancers. RESULTS A total of 19 studies were identified and reviewed. Major hepatectomy was undertaken in 391 patients. The median overall survival for pancreatic cancer ranged from 5-36 mo and for biliary tract/gallbladder cancer, it was 8-38 mo. The 30 d mortality rate was only 1%-9%. Overall Survival was significantly better for patients, who had good response to neoadjuvant chemotherapy, underwent metachronous liver resection and who had intestinal type tumours. CONCLUSION Resection of liver metastases in pancreatic and biliary cancers may provide survival benefit without compromising safety and quality of life in a very select group of patients. These data may be utilised to formulate selection criteria that may allow future investigation of resection in the era of more effective systemic therapy.

IntroductionThe problems associated with recruitment and retention of patients in clinical trials have been widely addressed in literature; however, similar problems associated with healthcare workers are rarely reported. The aim of this paper is to outline the factors that can impede a participant’s successful participation in a research project and to analyse the characteristics of participants that withdrew.MethodsThe Laparoscopic Simulation Skills Program (LSSP) was a prospective randomised cohort study investigating the efficacy of self-directed learning for basic laparoscopic skills acquisition. Two hundred and seven medical students, junior doctors, as well as surgical and gynaecology trainees were enrolled between June 2015 and November 2016.ResultsFifty-six (27%) participants failed to attend the final assessment. Of these, 43 participants (77%) responded to the follow-up survey and/or phone contact regarding non-attendance. Most participants failed to attend due to lack of free time/conflicting clinical duties and university requirements. Participants who did not attend the final assessment and did not provide further responses were less motivated by a career in surgery, surgical simulation and perceived less benefits of laparoscopic simulation. The 43 participants who answered the survey and/or phone contact provided similar responses to the participants who completed the study requirements and had more intrinsic motivators to enrol.ConclusionsClinical duties and other educational commitments are the biggest barriers to participation in simulation based-education research.

Introduction The use of safety checklists in interventional radiology is an intervention aimed at reducing mortality and morbidity. Currently there is little known about their practical use in Australian radiology departments. The primary aim of this mixed methods study was to evaluate how safety checklists (SC) are used and completed in radiology departments within Australian hospitals, and attitudes towards their use as described by Australian radiologists. Methods A mixed methods approach employing both quantitative and qualitative techniques was used for this study. Direct observations of checklist use during radiological procedures were performed to determine compliance. Medical records were also audited to investigate whether there was any discrepancy between practice (actual care measured by direct observation) and documentation (documented care measured by an audit of records). A focus group with Australian radiologists was conducted to determine attitudes towards the use of checklists. Results Among the four participating radiology departments, overall observed mean completion of the components of the checklist was 38%. The checklist items most commonly observed to be addressed by the operating theatre staff as noted during observations were correct patient (80%) and procedure (60%). Findings from the direct observations conflicted with the medical record audit, where there was a higher percentage of completion (64% completion) in comparison to the 38% observed. The focus group participants spoke of barriers to the use of checklists, including the culture of radiology departments. ConclusionThis is the first study of safety checklist use in radiology within Australia. Overall completion was low across the sites included in this study. Compliance data collected from observations differed markedly from reported compliance in medical records. There remain significant barriers to the proper use of safety checklists in Australian radiology departments. Refereed/Peer-reviewed

This study aimed to investigate the cancer characteristics,treatments administered and outcomes for nonagenarians and centenarians diagnosed with mCRC using our state-wide population-based mCRC registry to understand the current patterns of care and outcomes in this age subgroup of patients. Refereed/Peer-reviewed

BACKGROUND: Infection may complicate surgical patients' hospital admission. The effect of hospital-acquired infections (HAIs) on processes of care among surgical patients who died is unknown. AIM: To investigate the effect of HAIs on processes of care in surgical patients who died in hospital. METHODS: Surgeon-recorded infection data extracted from a national Australian surgical mortality audit (2012-2016) were grouped into HAIs and no infection. The audit included all-age surgical patients, who died in hospital. Not all patients had surgery. Excluded from analysis were patients with community-acquired infection and those with missing timing of infection. Multivariate logistic regression was used to determine the adjusted effects of HAIs on the processes of care in these patients. Costs associated with HAIs were estimated. FINDINGS: One-fifth of surgical patients who died did so with an HAI (2242 out of 11,681; 19.2%). HAI patients had increased processes of care compared to those who died without infection: postoperative complications [51.0% vs 30.3%; adjusted odds ratio (aOR): 2.20; 95% confidence interval (CI): 1.98-2.45; P < 0.001]; unplanned reoperations (22.6% vs 10.9%; aOR: 2.38; 95% CI: 2.09-2.71; P < 0.001) and unplanned intensive care unit admission (29.3% vs 14.8%; aOR: 2.18; 95% CI: 1.94-2.45; P < 0.001). HAI patients had longer hospital admissions and greater hospital costs than those without infection. CONCLUSION: HAIs were associated with increased processes of care and costs in surgical patients who died; these outcomes need to be investigated in surgical patients who survive.

Surgical education has changed; the classical ‘see one, do one, teach one’ philosophy has become increasingly hard to practice. Simulation-based education (SBE) has evolved as an effective tool to address the learning needs of healthcare professionals while maintaining the health and safety of patients. The quality and size of published evidence showing the utility of SBE and its role in the acquisition of both technical and non-technical surgical skills continues to increase. However, although many simulated skills courses have proven to be beneficial,1 2 the optimum format for the delivery of laparoscopic simulation training is still unclear. To better understand the role of training formats in SBE, the Royal Australasian College of Surgeons (RACS) implemented the Laparoscopic Simulation Skills Program (LSSP). The aim of the LSSP was to determine the best format for delivery of simulated laparoscopic skills training. The LSSP delivered a technical skills training programme in metropolitan and regional Australia. As part of this programme, a questionnaire was used to record participants’ perceptions on the utility of laparoscopic simulation training, barriers and motivators for attending training, as well as preferences for SBE delivery. The results of this survey are presented in this article to examine how participants’ opinions and choices direct their participation in the programme. A postcourse questionnaire was …

Training in laparoscopic surgery is important not only to acquire and improve skills but also avoid the loss of acquired abilities. The aim of this single-centre, prospective randomized study was to assess skill acquisition of different laparoscopic techniques and identify the point in time when acquired skills deteriorate and training is needed to maintain these skills. Sixty surgical novices underwent laparoscopic surgery (LS) and single-incision laparoscopic surgery (SILS) baseline training (BT) performing two validated tasks (peg transfer, precision cutting). The novices were randomized into three groups and skills retention testing (RT) followed after 8 (group A), 10 (group B) or 12 (group C) weeks accordingly. Task performance was measured in time with time penalties for insufficient task completion. 92 % of the participants completed the BT and managed to complete the task in the required time frame of proficiency. Univariate and multivariate analyses revealed that SILS (P

Background Studies show increased rates of mortality for admissions on the weekend (WE) versus the weekday (WD). However, scepticism exists of this so-called ‘weekend effect’ on patient outcome. It remains poorly investigated, particularly the timing of the day of surgery and post-operative outcomes. A UK study found higher odds of death when operated on Friday and the WE, versus WD. This relationship was investigated by interrogating the Australian and New Zealand Audit of Surgical Mortality database. Methods A standardized tool is used to collect data after every surgical death. Data in this retrospective cohort study from participating private and public hospitals in Australia on elective and emergency operations were extracted and included 7718 patients who had a surgical procedure within 30 days of admission and who subsequently died. A proxy measure of early surgical mortality, namely odds of dying within the first 48 h following surgery, was used to compare surgical mortality across days of the week. Results Unadjusted and adjusted odds of early surgical mortality were higher on the WE compared to WD, unadjusted and adjusted OR 1.30 (P < 0.001) and 1.19 (P = 0.026), respectively. When separated by day of week, there was a trend for higher surgical mortality on Friday, Saturday and Sunday versus all other days, although this did not reach statistical significance. ASA grade and specialty of surgery were important predictors of outcome. Conclusion There appears to be an association between day of surgery and surgical outcome. The exact cause and contributing factors requires further investigation.

Background The best surgeons demonstrate skills beyond those required for the performance of technically competent surgery. These skills are described under the term nontechnical skills. Failure in these domains has been associated with adverse events inside the operating room. These nontechnical skills are not learned commonly in a structured manner during surgery training. The main purpose of this study was to explore the effects of participation in simulation-based training, either as a sole strategy or as part of a combined approach on surgeons and surgical trainees nontechnical skills performance in simulation environment. Methods The study consisted of a single-blinded, prospective comparative trial. Forty participants were enrolled, all participating in 2 simulation sessions challenging nontechnical skills comprising 3 surgical scenarios. Seventeen participants attended a 1-day, nontechnical skills workshop between simulation sessions. Scenarios were video-recorded for assessment and debriefing purposes. Assessment was made by 2 observers using the Non-Technical Skills for Surgeons (NOTSS) scoring system. Results There was a significant improvement in nontechnical skills performance of both groups from the first to the second simulation session, for 2 of the 3 scenarios. No difference in performance between the simulation and the simulation plus workshop groups was noted. Conclusion This study provides evidence that formal training in nontechnical skills is feasible and can impact positively participants' nontechnical performance in a simulated environment. The addition of a 1-day didactic workshop does not seem to provide additional benefit over simulation-based training as a sole strategy for nontechnical skills training.

Background:There is growing trend for some surgical procedures previously performed in hospitals to be done in alternative settings, including office-based facilities. There has been some safety concerns reported in the media, which document serious adverse events following procedures performed in an office-based setting. To understand the current regulatory oversight of surgery in this setting ASERNIP-S conducted a review of the legislative and accreditation process governing these facilities in Australia.Methods:Using rapid review methodology, internet searches targeted government Web sites for relevant publicly-available documents. Use of consolidated versions of legislative instruments ensured currency of information. Standards were sourced directly from the issuing authorities or those that oversee the accreditation process.Results:Within Australia, healthcare facilities for surgery and their licensing are defined by each state and territory, which results in significant jurisdictional variation. These variations relate to the need for anesthesia beyond conscious sedation and listing of procedures in legislative instruments. In 2013, Australia adopted National Safety and Quality Health Service standards (NSQHS standards) for the accreditation of hospitals and day surgery centers; however, there is no NSQHS standard for office-based facilities. The main legislative driver for compliance is access to reimbursement schemes for service delivery.Conclusions:The legislative and accreditation framework creates a situation whereby healthcare facilities that provide services outside the various legal definitions of surgery and those not covered by a reimbursement scheme, can operate without licensing and accreditation oversight. This situation exposes patients to potential increased risk of harm when receiving treatment in such unregulated facilities.

Hepatic resection is a relatively young and complex specialized procedure. A strong relationship between volume and perioperative mortality has been reported internationally. However, there has been no multicentre study into hepatic resection in Australia. This retrospective, population-based cohort study was conducted to determine national, state and territory based volume and perioperative mortality rates (POMRs).Australian Institute of Health and Welfare data was interrogated for the Australian Classification of Health Intervention codes for hepatic resection defined as extended hemi-hepatectomy (30421), hemi-hepatectomy (30418), segmental hepatic resection (30415) and sub-segmental hepatic resection (30414). Logistic regression analysis was performed using the de-identified data to investigate trends and differences between states/territories. Mortality rates were risk adjusted for age, gender and public or private admission. The data set included patients who underwent hepatic resection in the financial years 2005/2006 to 2012/2013.The overall POMR for all types of hepatic resection was 1.6% (201/12 562). There was no significant change in POMR over time. However, there was significant variation between the states and territories with two states having significantly higher POMR for major hepatic resections (regional range: 1.3-3.8%). POMRs increased with age with the highest mortality seen in the 75-79 year age group. The POMR was lower in private than in public hospitals.The results of this study confirm that the overall Australian POMR for major hepatic resection is similar to results reported internationally. National and state/territory POMR has not varied significantly over time. The significant variation between states/territories warrants further investigation.

Morbidity and mortality (MM) meetings contribute to surgical education and improvements in patient care through the review of surgical outcomes; however, they often lack defined structure, objectives and resource support. The aim of this study was to investigate the factors that impact the effective conduct of MM meetings.We conducted a rapid systematic literature review. Three biomedical databases (PubMed, the Cochrane Library and the University of York Centre for Reviews and Dissemination), clinical practice guideline clearinghouses and grey literature sources were searched from May 2009 to September 2016. Studies that evaluated the function of a hospital-based MM process were included. Two independent reviewers conducted study selection and data extraction. Study details and key findings were reported narratively.Nineteen studies identified enablers, and seven identified barriers, to the effective conduct of MM meetings. Enabling factors for effective MM meetings included a structured meeting format, a structured case identification and presentation, and a systems focus. Absence of key personnel from meetings, lack of education regarding the meeting process, poor perceptions of the process, logistical issues and heterogeneity in case evaluation were identified as barriers to effective MM meetings.Taking steps to standardize and incorporate the enabling factors into MM meetings will ensure that the valuable time spent reviewing MM is used effectively to improve patient care.

Background and Objectives. Most gastric cancer patients now undergo perioperative chemotherapy (POCT) based on the MAGIC trial results. POCT consists of neoadjuvant chemotherapy (NACT) as well as postoperative adjuvant chemotherapy. This study assessed the applicability of perioperative chemotherapy and the impact of radical gastrectomy encompassing a detailed lymph-node resection on outcomes of gastric cancer. Methods. Medical and pathology records of all gastric carcinoma resections were reviewed from 2006 onwards. Pathological details, number of lymph-nodes resected, and proportion of involved nodes, reasons for nonadministration of NACT, complications, recurrence, and survival data were analysed. Results. Only twenty-eight (37.8%) out of 74 patients underwent NACT and only nine completed POCT. NACT was declined due to comorbidities/patient refusal n=24, early stage n=14, and emergency presentation n=8. Patients receiving NACT were much younger. Anastomotic leaks, hospital-mortality, lymph-node yield, and proportion of involved lymph-nodes were similar in both groups. Thirty-two patients died due to recurrence with lymph-node involvement heralding higher recurrence risk and much poorer survival (HR 2.66; p=0.013). Conclusion. More than 60% patients with resectable gastric carcinoma did not undergo NACT. Radical gastrectomy with lymphadenectomy remained the cornerstone of treatment in this period.

The Western Australian Audit of Surgical Mortality was established in 2002. A 10-year analysis suggested it was the primary driver in the subsequent fall in surgeon-related mortality. Between 2004 and 2010 the Royal Australasian College of Surgeons established mortality audits in other states. The aim of this study was to examine national data from the Australian Institute of Health and Welfare (AIHW) to determine if a similar fall in mortality was observed across Australia.The AIHW collects procedure and outcome data for all surgical admissions. AIHW data from 2005/2006 to 2012/2013 was used to assess changes in surgical mortality.Over the 8 years surgical admissions increased by 23%, while mortality fell by 18% and the mortality per admission fell by 33% (P0.0001). A similar decrease was seen in all regions. The mortality reduction was overwhelmingly observed in elderly patients admitted as an emergency.The commencement of this nation-wide mortality audit was associated with a sharp decline in perioperative mortality. In the absence of any influences from other changes in clinical governance or new quality programmes it is probable it had a causal effect. The reduced mortality was most evident in high-risk patients. This study adds to the evidence that national audits are associated with improved outcomes.

Background In addition to technical expertise, surgical competence requires effective non-technical skills to ensure patient safety and maintenance of standards. Recently the Royal Australasian College of Surgeons implemented a new Surgical Education and Training (SET) curriculum that incorporated non-technical skills considered essential for a competent surgeon. This study sought to compare the non-technical skills of experienced surgeons who completed their training before the introduction of SET with the non-technical skills of more recent trainees. Methods Surgical trainees and experienced surgeons undertook a simulated scenario designed to challenge their non-technical skills. Scenarios were video recorded and participants were assessed using the Non-Technical Skills for Surgeons (NOTSS) scoring system. Participants were divided into subgroups according to years of experience and their NOTSS scores were compared. Results For most NOTSS elements, mean scores increased initially, peaking around the time of Fellowship, before decreasing roughly linearly over time. There was a significant downward trend in score with increasing years since being awarded Fellowship for six of the 12 NOTSS elements: considering options (score −0·015 units per year), implementing and reviewing decisions (−0·020 per year), establishing a shared understanding (−0·014 per year), setting and maintaining standards (−0·024 per year), supporting others (−0·031 per year) and coping with pressure (−0·015 per year). Conclusion The drop in NOTSS score was unexpected and highlights that even experienced surgeons are not immune to deficiencies in non-technical skills. Consideration should be given to continuing professional development programmes focusing on non-technical skills, regardless of the level of professional experience.

Objective: Brain metastasis is considered rare in metastatic colorectal cancer (mCRC); thus, surveillance imaging does not routinely include the brain. The reported incidence of brain metastases ranges from 0.6% to 3.2%. Methods: The South Australian mCRC Registry (SAmCRC) was analyzed to assess the number of patients presenting with brain metastasis during their lifetime. Due to small numbers, a descriptive analysis is presented. Results: Only 59 patients of 4,100 on the registry at the time of analysis had developed brain metastasis (1.4%). The clinical characteristics of those with brain metastasis were as follows: the median age was 65.3 years and 51% were female. Where the V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status of the tumor was known, the majority harbored a KRAS mutation (55%); 31 (53%) underwent craniotomy and 55 (93%) underwent whole-brain radiotherapy. The median survival time from diagnosis of brain metastasis was 4.2 months (95% confidence interval 2.9–5.5). Patients who underwent craniotomy and radiotherapy had superior survival compared to those who underwent whole-brain radiotherapy (8.5 months vs. 2.2 months, respectively). Data from the SAmCRC (a population-based registry) confirm that brain metastases are rare and the median time to development is approximately 2 years. Conclusions: Brain metastasis is a rare outcome in advanced CRC. Patients within the registry tended to be female, young in age, and harbored with higher rates of KRAS mutations. Whether routine surveillance brain scanning should be considered remains controversial given the relative rarity of developing brain metastases in mCRC and ultimately, most patients with central nervous system involvement die from their extracranial disease.

BACKGROUND Previous reports have described differences in biology and outcome for colorectal cancer based on whether the primary is right or left sided. Further division by right, left, and rectum or even exact primary site has also been explored. Possible differences in response to biological agents have also been reported based on side of primary lesion. METHODS We explored the South Australian registry for metastatic colorectal cancer to assess if there were any differences in patient characteristics, prognostic markers, and treatment received and outcomes based on whether the primary was right or left sided. We also explored if differences exist based on left colon and rectum and by exact primary site. RESULTS Two thousand nine hundred seventy-two patients were analyzed. Thirty-five percent had a right-sided primary. The median overall survival for the entire group right versus left was 9.6 versus 20.3 months (P

Objective: To compare the management and outcome of rural and metropolitan patients with metastatic colorectal cancer (mCRC) in South Australia. Conclusion: Patterns of chemotherapy and surgical management of rural patients with mCRC in SA are equivalent to their metropolitan counterparts and lead to comparable overall survival. The centralised model of oncological care in SA may ensure rural patients gain access to optimal care. Design, setting and patients: Retrospective cohort study of patients with mCRC submitted to the South Australian mCRC registry between 2 February 2006 and a cut-off date of 28 May 2012. Main outcome measures: Differences in oncological and surgical management and overall survival (calculated using the Kaplan-Meier method) between city and rural patients. Results: Of 2289 patients, 624 (27.3%) were rural. There was a higher proportion of male patients in the rural cohort, but other patient characteristics did not significantly differ between the cohorts. Equivalent rates of chemotherapy administration between city and rural patients were observed across each line of treatment (first line: 56.0% v 58.3%, P = 0.32; second line: 23.3% v 22.5%, P = 0.78; and third line: 10.1% v 9.3%, P = 0.69). A higher proportion of city patients received combination chemotherapy in the first-line setting (67.4% v 59.9%; P = 0.01). When an oxaliplatin combination was prescribed, oral capecitabine was used more frequently in rural patients (22.9% v 8.4%; P < 0.001). No significant difference was seen in rates of hepatic resection or other non-chemotherapy treatments between cohorts. Median overall survival was equivalent between city and rural patients (14.6 v 14.9 months, P = 0.18). Refereed/Peer-reviewed

Objective Previous Australian studies have suggested poorer survival of patients with colorectal cancer in remote areas. To date no studies have assessed the geographic disparity in patients with metastatic disease. This retrospective cohort study looks at geographic differences in the surgical care and survival of patients with metastatic colorectal disease. The paper utilises data from the South Australian Clinical Registry for Metastatic Colorectal Cancer (SACRMCC). Design, participants, interventions and main outcome measures Data on patients' socio-economic status, primary and metastatic tumour characteristics, treatment and survival was extracted from the SACRMCC database. A binomial model analysis was used to identify geographical differences in the surgical treatment of patients and a Cox proportional hazards model was used to identify any geographic differences in survival. Results The findings showed no differences in the diagnosis of liver metastases or provision of liver surgery between geographic areas, however there was a reduced likelihood of liver surgery with increasing age. The median overall survival rate, from the date of diagnosis of metastatic disease, was 20.0 months and the distribution by geographic remoteness was 19.1 months, 20.2 months, 22.0 months and 20.4 months in Major Cities, Inner Regional, Outer Regional and Remote areas respectively. This was not statistically significant. Conclusion Overall, there was no evidence of a geographical disparity in the diagnosis, surgical treatment or survival in metastatic colorectal cancer. This may be due to the shift toward centralising surgical care in South Australia. Nevertheless, there remains a need to improve the uptake of surgical care in the growing elderly population.

Background Improved outcomes are desirable results of clinical audit. The aim of this study was to use data from the Victorian Audit of Surgical Mortality (VASM) and the Victorian Admitted Episodes Dataset (VAED) to highlight specific areas of clinical improvement and reduction in mortality over the duration of the audit process. Methods This study used retrospective, observational data from VASM and VAED. VASM data were reported by participating public and private health services, the Coroner and self-reporting surgeons across Victoria. Aggregated VAED data were supplied by the Victorian Department of Health. Assessment of outcomes was performed using chi-squared trend analysis over successive annual audit periods. Because initial collection of data was incomplete in the recruitment phase, statistical analysis was confined to the last 3-year period, 2010–2013. Results A 20% reduction in surgical mortality over the past 5 years has been identified from the VAED data. Progressive increase in both surgeon and hospital participation, significant reduction in both errors in management as perceived by assessors and increased direct consultant involvement in cases returned to theatre have been documented. Conclusions The benefits of VASM are reflected in the association with a reduction of mortality and adverse clinical outcomes, which have clinical and financial benefits. It is a purely educational exercise and continued participation in this audit will ensure the highest standards of surgical care in Australia. This also highlights the valuable collaboration between the Victorian Department of Health and the RACS.

Background Simulation-based training assumes that skills are directly transferable to the patient-based setting, but few studies have correlated simulated performance with surgical performance. Methods A systematic search strategy was undertaken to find studies published since the last systematic review, published in 2007. Inclusion of articles was determined using a predetermined protocol, independent assessment by two reviewers and a final consensus decision. Studies that reported on the use of surgical simulation-based training and assessed the transferability of the acquired skills to a patient-based setting were included. Results Twenty-seven randomized clinical trials and seven non-randomized comparative studies were included. Fourteen studies investigated laparoscopic procedures, 13 endoscopic procedures and seven other procedures. These studies provided strong evidence that participants who reached proficiency in simulation-based training performed better in the patient-based setting than their counterparts who did not have simulation-based training. Simulation-based training was equally as effective as patient-based training for colonoscopy, laparoscopic camera navigation and endoscopic sinus surgery in the patient-based setting. Conclusion These studies strengthen the evidence that simulation-based training, as part of a structured programme and incorporating predetermined proficiency levels, results in skills transfer to the operative setting.

Background Simulation-based training has become an increasingly accepted part of surgical training. However, simulators are still not widely available to surgical trainees. Some factors that hinder the widespread implementation of simulation-based training are the lack of standardized methods and equipment, costs and time constraints. We have developed a Mobile Simulation Unit (MSU) that enables trainees to access modern simulation equipment tailored to the needs of the learner at the trainee's workplace. Methods From July 2012 to December 2012, the MSU visited six hospitals in South Australia, four in metropolitan and two in rural areas. Resident Medical Officers, surgical trainees, Fellows and International Medical Graduates were invited to voluntarily utilize a variety of surgical simulators on offer. Participants were asked to complete a survey about the accessibility of simulation equipment at their workplace, environment of the MSU, equipment available and instruction received. Utilization data were collected. Results The MSU was available for a total of 303 h over 52 days. Fifty-five participants were enrolled in the project and each spent on average 118 min utilizing the simulators. The utilization of the total available time was 36%. Participants reported having a poor access to simulation at their workplace and overwhelmingly gave positive feedback regarding their experience in the MSU. Conclusion The use of the MSU to provide simulation-based education in surgery is feasible and practical. The MSU provides consistent simulation training at the surgical trainee's workplace, regardless of geographic location, and it has the potential to increase participation in simulation programmes.

A systematic review to determine whether skills acquired through simulation-based training transfer to the operating room for the procedures of laparoscopic cholecystectomy and endoscopy.Simulation-based training assumes that skills are directly transferable to the operation room, but only a few studies have investigated the effect of simulation-based training on surgical performance.A systematic search strategy that was used in 2006 was updated to retrieve relevant studies. Inclusion of articles was determined using a predetermined protocol, independent assessment by 2 reviewers, and a final consensus decision.Seventeen randomized controlled trials and 3 nonrandomized comparative studies were included in this review. In most cases, simulation-based training was in addition to patient-based training programs. Only 2 studies directly compared simulation-based training in isolation with patient-based training. For laparoscopic cholecystectomy (n = 10 studies) and endoscopy (n = 10 studies), participants who reached simulation-based skills proficiency before undergoing patient-based assessment performed with higher global assessment scores and fewer errors in the operating room than their counterparts who did not receive simulation training. Not all parameters measured were improved. Two of the endoscopic studies compared simulation-based training in isolation with patient-based training with different results: for sigmoidoscopy, patient-based training was more effective, whereas for colonoscopy, simulation-based training was equally effective.Skills acquired by simulation-based training seem to be transferable to the operative setting for laparoscopic cholecystectomy and endoscopy. Future research will strengthen these conclusions by evaluating predetermined competency levels on the same simulators and using objective validated global rating scales to measure operative performance.

INTRODUCTIONUpper Gastrointestinal Tract (UGIT) malignancy is an increasing problem in western society and its prognosis is generally poor. The prognosis dims even further with the presence of loco regional recurrences or distant metastasis. This article looks at the feasibility and potential benefit from resection of non-hepatic, non-nodal metastases and recurrences.PRESENTATION OF CASECase 1. A 72-year-old male who underwent total gastrectomy for a gastric adenocarcinoma presented with a splenic mass 40 months later and underwent a splenectomy. He is disease free at 30 months post-metastectomy. Case 2. A 54-year-old male with oesophagogastric junctional adenocarcinoma, underwent an Ivor-Lewis oesophagectomy. He developed a distal pancreatic mass at 24 months follow-up and underwent distal pancreatectomy and splenectomy. He is disease free at 12 months post-metastectomy. Case 3. A 75-year-old male underwent subtotal gastrectomy for lesser curvature adenocarcinoma. At 42 months follow-up, he developed solitary abdominal wall recurrence. This was locally resected with clear margins. After 12 months, he developed another full thickness abdominal wall recurrence with involvement of the hepatic flexure. Enbloc resection including right hemicolectomy was performed and he is disease free at 3 months.DISCUSSIONThere is very scarce literature on resection of non-hepatic, non-nodal recurrences/distant metastasis in oesophagogastric cancers. Based on these cases, a surgical resection in selected cases may provide prolonged survival with good quality of life.CONCLUSIONResection for isolated recurrences and metachronous metastasis from UGIT cancers may be worthwhile, especially if patients have minimal co-morbidities.

Introduction:Our research group recently evaluated a minimally invasive surgical procedure in order to inform a reimbursement decision. The application for funding was designed around the study selection criteria from a single pivotal randomized controlled trial (RCT). The aim of this study review was to evaluate the safety and effectiveness of this minimally invasive surgical procedure, and document challenges faced in evaluating a technology based on a highly targeted population.Methods:A systematic literature search of four biomedical databases was conducted (PubMed, Embase, Cochrane library, York CRD) up to 8 August 2017. Specific elements related to the population were patient age, together with level and duration of pain. Primary effectiveness outcomes included pain, patient reported quality of life, mortality and adverse events. The included RCTs were critically appraised against the Cochrane risk of bias tool. Meta-analysis was not possible due to the limited availability of evidence with consistent outcomes.Results:From 4,718 search results, only one pivotal RCT specifically met the inclusion criteria, which demonstrated favorable safety and effectiveness of the procedure; however, the sample population in the trial had limited external validity to the proposed reimbursement population and follow-up was limited to six months. As a result, the selection criteria were broadened to better reflect the manner in which the service may be provided in clinical practice, and capture longer-term safety concerns. Four additional RCTs were included, which provided contradictory results.Conclusions:The results of this review identified two important issues in evaluating a health technology where the assessment has been focused to the results of a single trial. In particular, the generalizability of a trial is defined by the demographic distribution of the sample, not the selection criteria. Designing the review selection criteria around the selection criteria for a single trial can have consequences for a funding decision.

4102 Background: Metastatic neuroendocrine neoplasms (mNEN’s) originating in the gastrointestinal tract are frequently slow growing yet both symptom and disease control remain important. Treatment options include resection, chemoablation, systemic somatostatin analogues (SSA) or peptide receptor radionuclide therapy (PRRT), but additional options are needed and one such option is hepatic intralesional (IL) rose bengal disodium (PV-10), an oncolytic immunotherapy under development for solid tumours. Methods: This phase 1 study is evaluating the safety, tolerability and reduction of biochemical markers and symptoms resulting from percutaneous administration of PV-10 in 12 subjects with progressive mNEN with hepatic lesions not amenable to resection or other potentially curative therapy. Target lesion(s) must be 1.0 - 3.9 cm in longest diameter. In Cohort 1 (n = 6) subjects receive PV-10 to a single hepatic lesion per treatment cycle, and can receive PV-10 to additional uninjected hepatic lesions ≥6 weeks after prior injection. Cohort 2 (n = 6) subjects may receive injection of multiple lesions per treatment cycle. The primary endpoint is safety. Secondary endpoints include objective response rate (ORR) assessed by contrast enhanced CT and 68Ga-DOTATATE PET, biochemical response (CgA) and patient-reported outcome (EORTC QLQ-C30 and GI.NET21). Results: Cohort 1 has fully enrolled, with 4 of 6 subjects male, median age 65yrs, range 47-72. Primary sites were: small bowel 3, pancreas 2, caecal 1; grade: Gd1 = 5, Gd2 = 1. All patients received prior SSA and PRRT. Median CgA was 645 (range 30-2819). To date 1 subject has received 4 PV-10 treatment cycles, 1 has received 2 cycles, and 4 have received a single cycle. Toxicity has been acceptable, including pain post procedure, carcinoid flare and nausea. LFT’s have remained stable. Overall QOL score was stable for 5 of 6 subjects. ORR in injected lesions is 50% (progression in 1 subject), with overall disease control of 84%. CgA response: 5 stable, 1 progression. One subject with “carcinoid pellagra” had rash resolution. Response follow-up is ongoing and additional efficacy and functional data will be presented. Conclusions: Hepatic IL PV-10 elicited no safety concerns with encouraging evidence of both local and systemic disease control. Enrolment to Cohort 2 is underway. Clinical trial information: NCT02693067.

Despite well-established guidelines on the age at which mechanical and bioprosthetic aortic valves are to be recommended to patients, it is observed that mechanical prosthesis are being eschewed in favour of bioprostheses. One potential explanation for this effect is the impact of TAVI which has

Objective High caseload is considered one of the most important factors for good outcomes after high-risk surgeries such as oesophagectomy. However, many Australian centres perform low volumes of oesophagectomies due to demographics. The aim of the present study was to audit outcome after oesophagectomy in an Australian low-volume centre over a period of 13 years and to discuss potential contributors to outcome other than just case volume. Methods Perioperative and long-term outcomes of all oesophagectomies over a 13-year period in a low-volume Australian tertiary care centre were analysed retrospectively. Data were compared in subgroups of patients in two separate time periods: 2000–05 (n=23) and 2006–12 (n=24). Results There were two perioperative deaths over the entire 13-year period with no postoperative mortality in the last decade. The complication and long-term survival rates for each of the two separate time periods were similar to those from high-volume centres, more so in the second half of the study period. Conclusions The data suggest that under specific conditions, oesophagectomies can be safely performed even in smaller- or low-volume centres in Australia. The policy of centralisation for these procedures in Australia needs to be carefully tailored to the needs of the population, clinical outcomes, cost-effectiveness and optimal utilisation of existing facilities rather than on caseload alone. What is known about the topic? High caseload is considered one of the most important factors for good outcomes after oesophagectomy and a driving force behind centralisation of this procedure. However, other factors may also affect outcome – such as availability of experienced surgeons, specialist nurses, interventional radiology, gastroenterology, etc. What does this paper add? With the availability of appropriate levels of expertise, infrastructure and specialist nursing staff as is the case in most Australian tertiary centres, good perioperative outcomes can be obtained despite low volumes. Case load only should not be used as a surrogate marker of quality. What are the implications for practitioners? The policy of centralisation for oesophagectomy in Australia needs to be carefully thought out on the basis of population demographics, outcomes and cost-effectiveness, with the appropriate use of existing facilities, rather than on a caseload basis alone.

This study was designed to evaluate the outcomes of pancreaticoduodenectomy (PD) at a low-volume specialised Hepato Pancreato Biliary (HPB) unit. Volume outcome analyses show significantly better results for patients undergoing PD at high-volume centres (Begg et al. JAMA 280:1747–1751, 1998; Finlayson et al. Arch Surg 138:721–725, 2003; Birkmeyer et al. N Engl J Med 346:1128–1137, 2002; Gouma et al. Ann Surg 232:786–795, 2000). Centralisation of PD seems to be the logical conclusion to be drawn from these results. In countries like Australia with a small and widely dispersed population, centralisation may not be always feasible. Alternative strategy would be to have similar systems in place to those in high-volume centres to achieve similar results at low-volume centres. Many Australian tertiary care centres perform low to medium volumes of PD (Chen et al. HPB 12:101–108, 2010; Kwok et al. ANZ J Surg 80:605–608, 2010; Barnett and Collier ANZ J Surg 76:563–568, 2006; Samra et al. Hepatobiliary Pancreat Dis Int 10:415–421, 2011). Most of these have a specialised HPB unit, accredited by the Australia and New Zealand Hepatic pancreatic and biliary association (ANZHPBA), as training units for post fellowship training in HPB surgery. It is imperative to perform outcome-based analyses in these units to ensure safety and high quality of care. Retrospective analysis of database for periampullary carcinoma (1998 till date) was performed in an ANZHPBA accredited HPB unit based at a tertiary care teaching hospital in South Australia. Because age older than 74 years is shown to be a predictive marker of increased morbidity and mortality after a PD, we analysed the outcomes in this subset of patients separately. Fifty-three patients underwent PD in 14 years. Overall mortality was 3.8 %. The last in hospital mortality was in 1999. The morbidity rates and the oncologic outcomes were similar to those in high-volume units. PD can be safely performed in a low-volume specialised unit at centres where the amenities and processes at high-volume centres can be replicated.

Introduction Analyses of adverse events inside the operating theatre has demonstrated that many errors are caused by failure in non-technical skills and teamwork. While simulation has been used successfully for teaching and improving technical skills, more recently, multidisciplinary simulation has been used for training team skills. We hypothesized that this type of training is feasible and improves team skills in the operating theatre. Methods A systematic search of the literature for studies describing true multidisciplinary operating theatre team simulation was conducted in November and December 2012. We looked at the characteristics and outcomes of the team simulation programmes. Results 1636 articles were initially retrieved. Utilizing a stepwise evaluation process, 26 articles were included in the review. The studies reveal that multidisciplinary operating theatre simulation has been used to provide training in technical and non-technical skills, to help implement new techniques and technologies, and to identify latent weaknesses within a health system. Most of the studies included are descriptions of training programmes with a low level of evidence. No randomized control trial was identified. Participants' reactions to the training programme were positive in all studies; however, none of them could objectively demonstrate that skills acquired from simulation are transferred to the operating theatre or show a demonstrable benefit in patient outcomes. Conclusion Multidisciplinary operating room team simulation is feasible and widely accepted by participants. More studies are required to assess the impact of this type of training on operative performance and patient safety.

BackgroundThe aim of this study was to establish the preference and reasons for initial axillary surgery performed on women with invasive breast cancer in Australia and New Zealand using data from the Breast Surgeon's Society of Australia and New Zealand Quality Audit (BQA) according to whether sentinel lymph node (SLN) biopsy, axillary lymph node dissection (ALND) or no axillary surgery was used.

Background Pyogenic liver abscess (PLA) is an uncommon but potentially life-threatening condition. Due to advances in diagnostic and treatment methods, the mortality rate has reduced in recent decades. The aim of this study was to gather recent data to examine PLA trends in South Australia. Methods The medical records of all patients admitted to The Queen Elizabeth Hospital, South Australia, between November 2000 and November 2009 with a primary or secondary diagnosis of PLA were retrospectively reviewed. Results Thirty-six patients were identified. Twenty (55.6%) were male and 16 (44.4%) female. The mean patient age was 70.2 years. A single PLA was found in 21 (58.3%) patients and multiple abscesses in 15 (41.7%) patients. Segment 7 of the liver was most commonly affected (10 cases). In 12 patients, multiple organisms were identified. Escherichia coli, Klebsiella pneumonia and Streptococcus species were most commonly identified. All patients received antibiotics and 27 (75%) received additional treatment. Nine patients received open abscess drainage. Fourteen received ultrasound-guided or computed tomography-guided percutaneous drainage or aspiration. One patient died as a direct result of a PLA. Discussion Since its first description, the epidemiology of PLA has changed. Patients diagnosed with PLA are now older, the male predominance is less and the organism more likely to originate from the biliary tract. The approach to PLA has also progressed with more accurate imaging and better treatment methods becoming available, which has resulted in a low mortality rate. This series confirms the described trends in South Australia.

Background Training in basic laparoscopic skills can be undertaken using traditional methods, where trainees are educated by experienced surgeons through a process of graduated responsibility or by simulation-based training. This study aimed to assess whether simulation trained individuals reach the same level of proficiency in basic laparoscopic skills as traditional trained participants when assessed in a simulated environment. Methods A prospective study was undertaken. Participants were allocated to one of two cohorts according to surgical experience. Participants from the inexperienced cohort were randomized to receive training in basic laparoscopic skills on either a box trainer or a virtual reality simulator. They were then assessed on the simulator on which they did not receive training. Participants from the experienced cohort, considered to have received traditional training in basic laparoscopic skills, did not receive simulation training and were randomized to either the box trainer or virtual reality simulator for skills assessment. The assessment scores from different cohorts on either simulator were then compared. Results A total of 138 participants completed the assessment session, 101 in the inexperienced simulation-trained cohort and 37 on the experienced traditionally trained cohort. There was no statistically significant difference between the training outcomes of simulation and traditionally trained participants, irrespective of the simulator type used. Conclusions The results demonstrated that participants trained on either a box trainer or virtual reality simulator achieved a level of basic laparoscopic skills assessed in a simulated environment that was not significantly different from participants who had been traditionally trained in basic laparoscopic skills.

Background The role of autologous fat transfer (AFT) for cosmetic breast augmentation is uncertain due to ongoing concerns regarding its safety and efficacy compared with other breast augmentation techniques. Objectives The aim of this systematic review was to assess the safety and efficacy of AFT for cosmetic breast augmentation in comparison with saline and cohesive silicone gel implants. Methods A systematic search of several electronic databases, including PubMed and EMBASE, was used to identify relevant studies for inclusion. The inclusion of studies was established through the application of a predetermined protocol by two independent reviewers. Results There were no comparative studies available, necessitating that all comparisons be indirect. Eighteen studies were included, 11 of which reported outcomes for AFT. Complications associated with AFT occurred in only a small proportion of patients, with fat necrosis, cysts and lumps most commonly reported. No data examining the effect of complications such as microcalcification on long-term mammographic and cancer-related outcomes were identified. Reabsorption of fat occurred to varying degrees, usually during the first 12 months following the procedure. Patient satisfaction following AFT was high. Limitation in breast volume increase was the main complaint associated with this procedure. Conclusions Based on the limited evidence available, AFT was considered to be at least as safe as the nominated comparator procedures in regard to complications; however, its safety in regard to cancer detection could not be determined. The efficacy of AFT could not be determined.

Background: Laparoscopic skills development via simulation-based medical education programs has gained support in recent years. However, the impact of training site type on skills acquisition has not been examined. The objective of this research was to determine whether laparoscopic skills training outcomes differ as a result of training in a Mobile Simulation Unit (MSU) compared with fixed simulation laboratories. Methods: An MSU was developed to provide delivery of training. Fixed-site and MSU laparoscopic skills training outcomes data were compared. Fixed-site participants from three Australian states were pooled to create a cohort of 144 participants, which was compared with a cohort derived from pooled MSU participants in one Australian state. Data were sourced from training periods held from October 2009 to December 2010. LapSim and Fundamentals of laparoscopic surgery (FLS) simulators were used at the MSU and fixed sites. Participants self-reported on demographic and experience variables. They trained to a level of competence on one simulator and were assessed on the other simulator, thus producing crossover scores. No participants trained at both site types. Results: When FLS-trained participants were assessed on LapSim, those who received MSU training achieved a significantly higher crossover score than their fixed-site counterparts (p < 0.001). Compared with baseline data, MSU LapSim-trained participants assessed on FLS displayed a performance increase of 23.1 %, whereas MSU FLS-trained participants assessed on LapSim demonstrated a 12.4 % increase in performance skills. Participants at fixed sites displayed performance increases of 5.2 and 10.9 %, respectively. Conclusions: Mobile Simulation Unit-delivered laparoscopic simulation training is not inferior to fixed-site training. Refereed/Peer-reviewed

Background The incidence of colorectal cancer in Australia is among the highest worldwide. We investigate whether similar treatment results for colorectal cancer can be achieved in rural surgery as reported from metropolitan centres. Methods Retrospective analysis of prospectively collected follow-up data in a rural surgical centre in South Australia has been carried out. Results of all patients undergoing surgical treatment for colorectal cancer are analysed, and all cancer stages and interventions over a 5-year period are included. Results Five-year survival of all patients (n = 194) treated for colorectal cancer independent of stage and cause of death was 56%, cancer-specific 5-year survival was 64%. Perioperative mortality was 1.7%. Overall survival was 96% in stage 1, 92% in stage 2, 58% in stage 3 and 0% for patients with metastatic disease at the time of diagnosis. Cancer-specific survival ranged from 100% in stage 1 to 0% for patients with metastatic disease. Conclusions Assessment of overall and cancer-specific survival of all patients undergoing surgery for colorectal cancer over a 5-year time period in a rural South Australian centre shows that good long-term results can be achieved with low perioperative mortality. These findings compare well with the results of other groups.

In surgical education research, enrolment of a sufficient number of surgeons is vital for the successful implementation of projects. The Royal Australasian College of Surgeons (RACS) is conducting a multicentre project investigating the efficacy and feasibility of a simulated laparoscopic skills course—titled the Laparoscopic Simulation Skills Program (LSSP). The primary target population for recruitment to the LSSP are surgical trainees and junior doctors, yet their enrolment and participation has been low compared to other eligible groups. It has been reported that motivators for doctors’ participation in clinical research correlates to their desire to update their own knowledge and the possibility of helping patients.1 Our project has focused on the first of these motivators and we have continuously refined communication processes to better engage, enrol and retain our target population. We describe the benefits and pitfalls of the engagement methods used by the LSSP to provide prospective researchers with strategies to improve enrolment of doctors in future research. ### Official contact Initial contact has been made via Officers in Medical and Surgical Administration and Medical Education. Officers are asked to distribute (via email) recruitment information using group distribution lists. #### Pros Mass email targets large populations quickly and easily. Moreover, using formal channels can add credibility to the project.2 This method maintains the confidentiality …

A decline in surgical deaths has been observed in Australia since the introduction of the Australian and New Zealand Audit of Surgical Mortality (ANZASM). The current study was conducted to determine whether the perioperative mortality rate (POMR) has also declined. This study is a retrospective review of the POMR for surgical procedures in Australian public hospitals between July 2009 and June 2013, using data obtained from the Australian Institute of Health and Welfare. Operative procedures contained in the Australian Refined Diagnosis Related Groups were selected and the POMR was modelled using urgency of admission, age and gender as explanatory covariates. The POMR in Australian public hospitals reduced by 15.4 % over the 4-year period. The emergency admissions POMR dropped from 1.40 to 1.12 %, and the elective admissions POMR from 0.09 to 0.08 %. The binary logistic regression model used to predict patient mortality showed emergency admissions to have a higher POMR than elective, being more evident at older ages. For emergency admissions, the difference in POMR between females and males increased with age, from about 55 years onwards, with females being lower. For elective surgeries, the difference between males and females was of little practical importance across ages. The reduction in the POMR in Australia confirms the reduction in surgical deaths reported to ANZASM. Continuing to monitor POMR will be important to ensure the safest surgery in Australia. Further investigations into case-mix will allow better risk adjustment and comparison between regions and time-periods, to facilitate continuous quality improvement.

Tumor growth, dissemination and metastasis are dependent on angiogenesis. The predominant vascular endothelial growth factor (VEGF) isoform that plays a major role in angiogenesis is VEGF-A. Indeed, VEGF-A is implicated in promoting angiogenesis of numerous solid malignancies, including colorectal cancer (CRC). A large body of preclinical and clinical evidence indicates that the expression of specific VEGF-A isoforms represents a predominant pro-angiogenic factor, which is associated with formation of metastases and poor prognosis in CRC patients. Different isoforms of human VEGF-A have been identified, all of which arise from alternative splicing of the primary transcript of a single gene. Notably, it has been recently demonstrated that expression of type 3 isoform pattern is significantly correlated with venous involvement in CRC as well as in progression to metastatic colorectal cancer (mCRC), although it remains unclear what proportion of CRC tumors express these isoforms. This review highlights the importance of investigating the genetic and the epigenetic variations in VEGF-A pathways in CRC, the functions of different VEGF-A isoforms and their potential application as prognostic markers and/or therapeutic targets. Better understanding of the mechanisms controlling angiogenesis in liver metastases is necessary to address the limitations of current anti-angiogenic therapies.

This systematic review evaluated the diagnostic accuracy and impact on patient management of hepatocyte-specific gadoxetic acid enhanced magnetic resonance imaging (GA-MRI) compared to contrast enhanced computed tomography (CE-CT) in patients with liver metastases. Four biomedical databases (PubMed, EMBASE, Cochrane Library, York CRD) were searched from January 1991 to February 2016. Studies investigating the accuracy or management impact of GA-MRI compared to CE-CT in patients with known or suspected liver metastases were included. Bias was evaluated using QUADAS-II. Univariate meta-analysis of sensitivity ratios (RR) were conducted in the absence of heterogeneity, calculated using I 2 , Tau values (τ) and prediction intervals. Nine diagnostic accuracy studies (537 patients with 1216 lesions) and four change in management studies (488 patients with 281 lesions) were included. Per-lesion sensitivity and specificity estimates for GA-MRI ranged from 86.9–100.0 % and 80.2–98.0 %, respectively, compared to 51.8–84.6 % and 77.2–98.0 % for CE-CT. Meta-analysis found GA-MRI to be significantly more sensitive than CE-CT (RR = 1.29, 95 % CI = 1.18–1.40, P

The expression of HLA-G by tumour cells is an established mechanism to escape recognition and immune mediated destruction, allowing tumour survival, growth and metastasis. However, the prognostic value of soluble HLA-G (sHLA-G) remains unknown. Mucinous carcinoma (MC) is a distinct form of colorectal cancer (CRC) found in 10 to 15% of patients, which has long been associated with poor response to treatment. To investigate the prognostic value of plasma sHLA-G levels in CRC patients, preoperative plasma sHLA-G levels were determined by ELISA in CRC patients (n = 133). In addition, the local expression of HLA-G in tumour biopsies was assessed using tissue microarray analysis (n = 255). Within the high 33rd percentile of sHLA-G levels (265-890 U/mL; n = 44) we observed higher frequency of MC patients (p = 0.012; Chi-square), and higher sHLA-G levels in patients with vascular invasion (p = 0.035; two-tailed t-test). Moreover, MC patients had significantly higher sHLA-G levels compared to those with adenocarcinoma not otherwise specified (p = 0.036; two-tailed t-test). Surprisingly, while stage II patients showed negative correlation between sHLA-G levels and liver metastasis free survival (LMFS) (p = 0.041; R = -0.321), in stage III patients high sHLA-G levels were associated with significantly longer LMFS (p = 0.002), and sHLA-G levels displayed positive correlation with LMFS (p = 0.006; R = 0.409). High HLA-G expression in tumours was associated with poor cancer specific overall survival in stage II to III (p = 0.01), and with shorter LMFS in stage II patients (p = 0.004). Our findings reveal that sHLA-G levels are associated with distinct progression patterns in consecutive disease stages, indicating a potential value as surrogate marker in the differential prognosis of CRC.

Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies. © 2009 Elsevier Ltd. All rights reserved.