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Objectives Gastric cancer remains one of the most fatal cancers, despite an intensive treatment regime of chemotherapy–surgery–chemotherapy. Peritoneal metastatic disease is commonly diagnosed post treatment regime and once established, patients are likely to die in 3–9 months. Systemic chemotherapy does not increase survival for these patients due to the poor vascularisation of this area. We are proposing the addition of pressurised intraperitoneal aerosol chemotherapy (PIPAC) to the treatment regime for curative patients as a preventive measure to reduce the risk of peritoneal metastases occurring. Methods This is a prospective, single centre, non-randomised, open-label pilot trial evaluating the addition of PIPAC to the standard multimodal treatment pathway. Patients will undergo standard neoadjuvant chemotherapy with four cycles of fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT), then PIPAC, followed by gastrectomy. Four cycles of FLOT will be administered post-surgery. Primary outcome is safety and feasibility, assessed by perioperative morbidity and possible interruptions of the standard multimodal treatment pathway.

Background Diverting ileostomy (DI) is utilised in rectal cancer surgery to mitigate the effects of anastomotic leak. The aim of this study was to assess the clinical risk factors associated with post-operative complications of DI reversal. Methods A single-centre retrospective analysis of patients who underwent surgical resection for rectal cancer and subsequent DI reversal between January 2012 and December 2020 was undertaken. Medical records were reviewed to extract clinical, operative and pathologic details and post-operative complications according to the Clavien-Dindo classification. Univariate and multivariable analyses were undertaken to assess risk factors associated with post-operative complications of DI reversal. Results One hundred and twenty-six adult patients who underwent DI reversal were included of which 49 had a post-operative complication (39%). The most common complication was prolonged post-operative ileus, which occurred in 24 patients (19%). On multivariable analysis smoking was significantly associated with overall complications (odds ratio [OR] = 5.60, 95% confidence interval [CI] 1.90-16.52, p = 0.0018), and high Clavien-Dindo (2-5) category complications (OR = 4.60, 95% CI 1.81-11.68, p = 0.0013). In addition, patients who received adjuvant chemotherapy were less likely to have a reversal of DI complication (OR = 0.43, 95% CI 0.19-0.94, p = 0.0342) and less likely to have a high Clavien-Dindo (2-5) category complication (OR = 0.44, 95% CI 0.20-0.93, p = 0.0311). Conclusion Smokers who have undergone surgical resection of rectal cancer have a significantly increased risk of post-operative complications after DI reversal. In these patients, the importance of smoking cessation must be emphasised. The decreased complication rate observed in patients who received adjuvant chemotherapy was an unexpected finding.

Trans-vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a recently popularised minimally invasive surgical procedure, aimed at minimising abdominal wall scars and improving pain and patient recovery times. Although vNOTES has been studied in the context of post-operative pain and cosmesis, women’s acceptance of the technique has only been cursorily examined. In this survey-based observational study, we assessed the acceptability of this technique among a cohort of Middle Eastern women. A cohort of 175 Middle Eastern women were surveyed using a 13-item questionnaire at a single gynaecology centre. The survey used was a translated version of a questionnaire from a previous study (1) and comprised open-response, five-point Likert Scale and agree-disagree items. Among 175 Middle Eastern women participated in this study most of them holding neutral view on abdominal and gynaecological procedures via vagina. 47% of participants were unsure regarding the effect of surgery via vagina on their sexual function. Although 61% of the participants showed no preference towards vNOTES over laparoscopic cholecystectomy, more than half of them indicated preference if vNOTES shown to be as effective and safe as laparoscopic cholecystectomy. The gender of the surgeon was shown to have no influence on the perspectives of the majority of participants to undergo vNOTES. vNOTES may hold value for women who have conservative upbringing and/or value cosmesis. This study provides information regarding Middle Eastern women’s perspectives on vNOTES, which may be of considerable clinical use as the popularity of this surgical technique continues to increase.

The purpose of this research was to investigate the diagnostic and prognostic value of circulating SFRP5 (cSFRP5) in colorectal cancer (CRC). We evaluated preoperative cSFRP5 levels in CRC patients and controls (n = 208). We found significantly higher cSFRP5 levels in CRC patients compared with non-CRC controls (p < 0.001). Levels of cSFRP5 were significantly lower in CRC patients with either vascular invasion (p = 0.001) or liver metastasis (p = 0.016). High cSFRP5 levels were associated with longer disease-free survival in both univariate (p = 0.024) and multivariate (p = 0.015) analyses. Analysis of an independent tissue cohort from The Cancer Genome Atlas database revealed significantly lower SFRP5 RNA expression in CRC tumor tissue compared with adjacent normal mucosa (n = 590 vs 47; p

BACKGROUND: Preoperative screening for coronavirus disease 2019 (COVID-19) aims to preserve surgical safety for both patients and surgical teams. This rapid review provides an evaluation of current evidence with input from clinical experts to produce guidance for screening for active COVID-19 in a low prevalence setting. METHODS: An initial search of PubMed (until 6 May 2020) was combined with targeted searches of both PubMed and Google Scholar until 1 July 2020. Findings were streamlined for clinical relevance through the advice of an expert working group that included seven senior surgeons and a senior medical virologist. RESULTS: Patient history should be examined for potential exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Hyposmia and hypogeusia may present as early symptoms of COVID-19, and can potentially discriminate from other influenza-like illnesses. Reverse transcription-polymerase chain reaction is the gold standard diagnostic test to confirm SARS-CoV-2 infection, and although sensitivity can be improved with repeated testing, the decision to retest should incorporate clinical history and the local supply of diagnostic resources. At present, routine serological testing has little utility for diagnosing acute infection. To appropriately conduct preoperative testing, the temporal dynamics of SARS-CoV-2 must be considered. Relative to other thoracic imaging modalities, computed tomography has the greatest utility for characterizing pulmonary involvement in COVID-19 patients who have been diagnosed by reverse transcription-polymerase chain reaction. CONCLUSION: Through a rapid review of the literature and advice from a clinical expert working group, evidence-based recommendations have been produced for the preoperative screening of surgical patients with suspected COVID-19.

BACKGROUND Laparoscopy has revolutionized the surgical field with the advent of minimally invasive techniques leading to smaller surgical wounds, enhanced recovery, early discharge from the hospital and early return to work. Since the initiation of three-dimensional (3D) systems, studies have failed to prove significant advantages over traditional two-dimensional systems which could be attributed to suboptimal image quality, poor illumination and high cost of earlier systems. Recent advances in stereoscopy have led to the introduction of high-definition (HD) systems with improvement in image quality in both two-dimensional and 3D systems. With HD and new 4K imaging system, the previous data are now obsolete. METHODS We devised a cross-over study using the Olympus 4K camera imaging system compared with the HD 3D systems using 40 novice surgeons with no prior surgical skills to perform standardized surgical tasks and the groups were crossed over to assess any difference in the learning curve with the imaging systems. RESULTS The data showed a statistically significant difference in errors performed with the 3D imaging system with reduction in errors for passing needle through a ring, knot tying, cutting circle and touching circles with a needle. The time taken to perform those tasks was comparable except in knot tying where there was significant reduction in the time taken to tie knots with a P-value of

BACKGROUND To assess the adherence rate of surveillance colonoscopy booking intervals to recommended National Health and Medical Research Council guidelines at The Queen Elizabeth Hospital, Adelaide, Australia. METHODS Patients on The Queen Elizabeth Hospital colorectal unit surveillance colonoscopy waiting list were included in this audit. Patient demographics, colonoscopy findings, follow-up plans and pathology results were analysed. Patients were categorized as normal/non-neoplastic finding, low-risk adenomas, high-risk adenomas, personal history of colorectal cancer (CRC) and family history of CRC. Booked colonoscopy within 2 months of guideline recommended interval was considered correct. RESULTS A total of 467 patients were included (59.1% male; mean age 60 years). Two hundred and fifty-one (53.7%) patients had an incorrect surveillance colonoscopy booking. Twenty-seven patients with a normal/non-neoplastic previous colonoscopy not requiring surveillance colonoscopy were incorrectly booked for a colonoscopy. For the 222 patients booked incorrectly and requiring surveillance colonoscopy, 88.7% were early and 11.3% were late. The proportions of incorrect bookings were highest in the low-risk finding (66.1%) and history of CRC (67.6%) groups. For the 186 patients requiring a 3-year surveillance interval, 38.7% were booked incorrectly. For the 197 patients requiring a 5-year surveillance interval, 63.5% were booked incorrectly, of which 99.2% were early. More 5-year surveillance interval patients were booked at 3 years (n = 79), than at the correct interval of 5 years (n = 72). CONCLUSION Adherence to the National Health and Medical Research Council guidelines for surveillance colonoscopy is poor. The majority of deviations represent early follow-up, which is most common among patients with low-risk findings or history of CRC. There is a tendency towards 3-year surveillance among low-risk patients.

Background Long‐term effects after COVID‐19 may affect surgical safety. This study aimed to evaluate the literature and produce evidence‐based guidance regarding the period of delay necessary for adequate recovery of patients following COVID‐19 infection before undergoing surgery. Methods A rapid review was combined with advice from a working group of 10 clinical experts across Australia and New Zealand. MEDLINE, medRxiv and grey literature were searched to 4 October 2020. The level of evidence was stratified according to the National Health and Medical Research Council evidence hierarchy. Results A total of 1020 records were identified, from which 20 studies (12 peer‐reviewed) were included. None were randomized trials. The studies comprised one case–control study (level III‐2 evidence), one prospective cohort study (level III‐2) and 18 case‐series studies (level IV). Follow‐up periods containing observable clinical characteristics ranged from 3 to 16 weeks. New or excessive fatigue and breathlessness were the most frequently reported symptoms. SARS‐CoV‐2 may impact the immune system for multiple months after laboratory confirmation of infection. For patients with past COVID‐19 undergoing elective curative surgery for cancer, risks of pulmonary complications and mortality may be lowest at 4 weeks or later after a positive swab. Conclusion After laboratory confirmation of SARS‐CoV‐2 infection, minor surgery should be delayed for at least 4 weeks and major surgery for 8–12 weeks, if patient outcome is not compromised. Comprehensive preoperative and ongoing assessment must be carried out to ensure optimal clinical decision‐making., A rapid review was combined with advice from a working group of 10 clinical experts across Australia and New Zealand to produce evidence‐based guidance regarding the period of delay necessary for adequate recovery of patients following COVID‐19 infection before undergoing surgery. We found that follow‐up periods containing observable clinical characteristics ranged from 3 to 16 weeks and SARS‐CoV‐2 may impact the immune system for multiple months after laboratory confirmation of infection. Therefore, after laboratory confirmation of SARS‐CoV‐2 infection, minor surgery should be delayed for at least 4 weeks and major surgery for 8–12 weeks, if patient outcome is not compromised; additionally comprehensive preoperative and ongoing assessment must be carried out to ensure optimal clinical decision‐making.

Pseudomyxoma Peritonei (PMP) and Peritoneal Mesothelioma (PM) are both rare peritoneal malignancies. Currently, affected patients may be treated with Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy offering long-term survival or even cure in selected patients. However, many issues regarding the optimal treatment strategy are currently under debate. To aid physicians involved in the treatment of these patients in clinical decision making, the PSOGI executive committee proposed to create a consensus statement on PMP and PM. This manuscript describes the methodology of the consensus process. The Delphi technique is a reliable method for attaining consensus on a topic that lacks scientific evidence through multiple voting rounds which feeds back responses to the participants in between rounds. The GRADE system provides a structured framework for presenting and grading the available evidence. Separate questionnaires were created for PMP and PM and sent during two voting rounds to 80 and 38 experts, respectively. A consensus threshold of 51.0% was chosen. After the second round, consensus was reached on 92.9%-100.0% of the questions. The results were presented and discussed in the plenary session at the PSOGI 2018 international meeting in Paris. A third round for the remaining issues is currently in progress. In conclusion, using the Delphi technique and GRADE methodology, consensus was reached in many issues regarding the treatment of PM and PMP amongst an international panel of experts. The main results will be published in the near future.

Primary appendiceal neoplasms (ANs) comprise a heterogeneous group of tumors. The pathology and classification of ANs have been controversial, and thus, a new classification of these neoplasms was published in the World Health Organization (WHO) classification of tumors (5th edition, 2019). However, immunohistochemistry (IHC) features of epithelial ANs are not explained in this edition and the limited data on the molecular pathology of these tumors shows inconsistent findings in various studies. It would be useful to identify biomarkers appropriate for each subtype to better aid in treatment selection. Therefore, we reviewed the literature to investigate what is known of the molecular pathology and IHC features of the most frequently diagnosed pathological subtypes of epithelial ANs based on the recent classification. The inconsistencies in research findings regarding the IHC features and molecular pathology of ANs could be due to differences in the number of samples and their collection and preparation as well as to the lack of a universally accepted classification system for these neoplasms. However, the literature shows that epithelial ANs typically stain positive for MUC2, CK20, and CDX2 and that the expression of SATB2 protein could be used as a biomarker for appendix tumor origin. Low-grade appendiceal mucinous neoplasms tend to have mutations in KRAS and GNAS but are usually wild-type for BRAF, APC, and P53. Conversely, appendiceal adenocarcinomas are frequently found with mutations in KRAS, GNAS, P53, PIK3CA, and APC, and have significant nuclear expression of ��-catenin, loss of nuclear or nuclear and cytoplasmic expression of SMAD4, and loss of cytoplasmic membranous expression of E-cadherin. Goblet cell carcinomas (GCCs) typically stain positive for keratin and mucin markers and are frequently mutated in P53 and chromatin-modifier genes, but they tend to be wild-type for KRAS, GNAS, APC, and PIK3CA. The expression of CK7 and SATB2 proteins is usually negative in appendiceal neuroendocrine neoplasms and they lack the mutations in common cancer-associated genes including APC, BRAF, SMAD4, and PIK3C. The available data suggest that GCCs have distinct molecular and immunohistochemical features and that they have characteristics more in common with adenocarcinoma than classical neuroendocrine tumors. In addition, MSI does not seem to have a role in the pathogenesis of epithelial ANs because they are rarely detected in these tumors. Finally, hereditary predisposition may have a role in the development of ANs because heterozygous CTNN��1, NOTCH1, and NOTCH4 germline mutations have recently been identified in low and high grades ANs.

The study aimed to examine the incidence and mortality rates of appendiceal neoplasms (ANs) in Australia.A retrospective analysis was performed on national data obtained from the Australian Institute of Health and Welfare (AIHW) from 1982 to 2013. Changes to the incidence, and the cancer-specific mortality following the diagnosis of ANs were analyzed over this time period, with stratification performed for histological subtype, gender, and age groups (50y and ≥50y).Incidence and mortality rates of ANs increased significantly across both genders and age groups. Incidence rates increased by 415%, from 0.40/100 000 population in 1982 to 2.06/100 000 in 2013. Overall mortality rates increased by 130%, from 0.057/100 000 during 1982-1985 to 0.131/100 000 during 2010-2013. Controlling for age group and gender, the incidence rates increased by 20% every four years (Incidence rate ratio (IRR) = 1.20, 95% confidence interval (CI): 1.17, 1.23, global P value0.0001), and controlling for age, the mortality rates increased by 8% every four years (IRR = 1.08, 95% CI: 1.00, 1.17, global P-value = 0.0401).The increasing use of CT scanning, improvements in pathological assessment of the appendix, and the growing aging population may have contributed in part to the apparent rise in the incidence of ANs.

BACKGROUND: The novel coronavirus, SARS-CoV-2, caused the COVID-19 global pandemic. In response, the Australian and New Zealand governments activated their respective emergency plans and hospital frameworks to deal with the potential increased demand on scarce resources. Surgical triage formed an important part of this response to protect the healthcare system's capacity to respond to COVID-19. METHOD: A rapid review methodology was adapted to search for all levels of evidence on triaging surgery during the current COVID-19 outbreak. Searches were limited to PubMed (inception to 10 April 2020) and supplemented with grey literature searches using the Google search engine. Further, relevant articles were also sourced through the Royal Australasian College of Surgeons COVID-19 Working Group. Recent government advice (May 2020) is also included. RESULTS: This rapid review is a summary of advice from Australian, New Zealand and international speciality groups regarding triaging of surgical cases, as well as the peer-reviewed literature. The key theme across all jurisdictions was to not compromise clinical judgement and to enable individualized, ethical and patient-centred care. The topics reported on include implications of COVID-19 on surgical triage, competing demands on healthcare resources (surgery versus COVID-19 cases), and the low incidence of COVID-19 resulting in a possibility to increase surgical caseloads over time. CONCLUSION: During the COVID-19 pandemic, urgent and emergency surgery must continue. A carefully staged return of elective surgery should align with a decrease in COVID-19 caseload. Combining evidence and expert opinion, schemas and recommendations have been proposed to guide this process in Australia and New Zealand.

Background Coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), has created a global pandemic. Surgical care has been impacted, with concerns raised around surgical safety, especially in terms of laparoscopic versus open surgery. Due to potential aerosol transmission of SARS‐CoV‐2, precautions during aerosol‐generating procedures and production of surgical plume are paramount for the safety of surgical teams. Methods A rapid review methodology was used with evidence sourced from PubMed, Departments of Health, surgical colleges and other health authorities. From this, a working group of expert surgeons developed recommendations for surgical safety in the current environment. Results Pre‐operative testing of surgical patients with reverse transcription‐polymerase chain reaction does not guarantee lack of infectivity due to a demonstrated false‐negative rate of up to 30%. All bodily tissues and fluids should therefore be treated as a potential source of COVID‐19 infection during operative management. Caution must be taken, especially when using an energy source that produces surgical plumes, and an appropriate capture device should also be used. Limiting the use of such devices or using lower energy devices is desirable. To reduce perceived risks association with desufflation of pneumoperitoneum during laparoscopic surgery, an appropriate suction irrigator system, attached to a high‐efficiency particulate air filter, should be used. Additionally, appropriate use of personal protective equipment by the surgical team is necessary during high‐risk aerosol‐generating procedures. Conclusions As a result of the rapid review, evidence‐based guidance has been produced to support safe surgical practice., Surgical care has been impacted by the coronavirus disease 2019 pandemic, with concerns raised around surgical safety, especially in terms of laparoscopic versus open surgery. Due to potential aerosol transmission of severe acute respiratory syndrome coronavirus 2, precautions during aerosol‐generating procedures and production of surgical plume are paramount for the safety of surgical teams. From a rapid review on the topic, a working group of expert surgeons developed evidence‐based guidance to support safe surgical practice in the current environment.

Purpose: Patients with colorectal cancer with peritoneal metastases (CRPMs) have limited treatment options and the lowest colorectal cancer survival rates. We aimed to determine whether organoid testing could help guide precision treatment for patients with CRPMs, as the clinical utility of prospective, functional drug screening including nonstandard agents is unknown. Experimental Design: CRPM organoids (peritonoids) isolated from patients underwent parallel next-generation sequencing and medium-throughput drug panel testing ex vivo to identify specific drug sensitivities for each patient. We measured the utility of such a service including: success of peritonoid generation, time to cultivate peritonoids, reproducibility of the medium-throughput drug testing, and documented changes to clinical therapy as a result of the testing. Results: Peritonoids were successfully generated and validated from 68% (19/28) of patients undergoing standard care. Genomic and drug profiling was completed within 8 weeks and a formal report ranking drug sensitivities was provided to the medical oncology team upon failure of standard care treatment. This resulted in a treatment change for two patients, one of whom had a partial response despite previously progressing on multiple rounds of standard care chemotherapy. The barrier to implementing this technology in Australia is the need for drug access and funding for off-label indications. Conclusions: Our approach is feasible, reproducible, and can guide novel therapeutic choices in this poor prognosis cohort, where new treatment options are urgently needed. This platform is relevant to many solid organ malignancies.

Background: Colorectal cancer (CRC) is rising in incidence in young adults, and this observation is currently unexplained. We investigated whether having a personal history of type 2 diabetes mellitus (T2D) was a potential risk factor for young-onset colorectal cancer (YOCRC). Methods: The South Australian Young Onset (SAYO) CRC study is a series of young adults with CRC below age 55. Ninety unrelated YOCRC cases were recruited to the study. Personal history and detailed family history of T2D were obtained at face-to-face interview and confirmed from medical records. Whole exome sequencing was conducted on germline DNA from each CRC case. Controls for personal history studies of T2D were 240 patients with proven clear colonoscopies and no known CRC predispositions. Results: The median age of YOCRC cases was 44 years (18–54) and of controls was 45 years (18–54), and 53% of both cases and controls were females (P = 0.99). Left-sided (distal) CRC was seen in 67/89 (75%) of cases. A personal history of T2D was confirmed in 17/90 (19%) YOCRC patients compared with controls (12/240, 5%; P < 0.001; odds ratio = 4.4; 95% confidence interval, 2.0–9.7). YOCRC patients frequently reported at least one first-degree relative with T2D (32/85, 38%). Ten of 87 (12%) of YOCRC cases had CRC-related pathogenic germline variants, however, no pathogenic variants in familial diabetes-associated genes were seen. Conclusions: Though the mechanism remains unclear, our observations suggest that there is enrichment for personal history of T2D in YOCRC patients. Impact: A diagnosis of T2D could therefore potentially identify a subset of young adults at increased risk for CRC and in whom early screening might be appropriate. Refereed/Peer-reviewed

This study reports the quality-of-life assessment of the ALCCaS trial. The ALCCaS trial compared laparoscopic and open resection for colon cancer. It reported equivalence of survival at 5 years. Quality of life was measured as a secondary outcome.This study aimed to report on the quality of life data of the ALCCaS Trial.This study reports a randomized controlled trial comparing laparoscopic with open colonic resection.The study was conducted in Australasia.Patients with a single adenocarcinoma of the right, left, or sigmoid colon, presenting for elective treatment, were eligible for randomization.Open and laparoscopic colonic resections were performed.Patient symptoms and quality of life were measured using the Symptoms Distress Scale, the Quality of Life Index, and the Global Quality of Life Score preoperatively, and at 2 days, 2 weeks, and 2 months postoperatively.Of the 592 patients enrolled in ALCCaS, 425 completed at least 1 quality-of-life measure at 4 time points (71.8% of cohort). Those who received the laparoscopic intervention had better quality of life postoperatively in terms of the Symptoms Distress Scale (p0.01), Quality of Life Index (p0.01), and Global Quality of Life (p0.01). In intention-to-treat analyses, those assigned to laparoscopic surgery had a better quality of life postoperatively in terms of the Symptoms Distress Scale (p0.01) and Quality of Life Index (p0.01), whereas Global Quality of Life was not significant (p = 0.056). The subscales better for laparoscopic resection at all 3 postoperative time points were appetite, insomnia, pain, fatigue, bowel, daily living, and health (p0.05).The primary limitation was the different response rates for the 3 quality-of-life measures.There was a short-term gain in quality of life maintained at 2 months postsurgery for those who received laparoscopic relative to open colonic resection. See Video Abstract at http://links.lww.com/DCR/A691.

IntroductionGastrointestinal recovery after surgery is of worldwide significance. Postoperative gastrointestinal dysfunction is multifaceted and known to represent a major source of postoperative morbidity, however, its significance to postoperative care across all surgical procedures is unknown. The complexity of postoperative gastrointestinal recovery is poorly defined within gastrointestinal surgery, and even less so outside this field. To inform the clinical care of surgical patients worldwide, this systematic review and meta-analysis will aim to characterise the duration of postoperative gastrointestinal recovery that can be expected across all surgical procedures and determine the associations between factors that may affect this.Methods and analysisMEDLINE, Embase, Cochrane Library and CINAHL will be searched for studies reporting the time to first postoperative passage of stool after any surgical procedure. We will screen records, extract data and assess risk of bias in duplicate. Forest plots will be constructed for time to postoperative gastrointestinal recovery, as assessed by various outcome measures. Because of potential heterogeneity, a random-effects model will be used throughout the meta-analysis. Funnel plots will be used to test for publication bias. Meta-regressions will be undertaken where the outcome is the mean time to first postoperative passage of stool, with potential predictors and confounders being patient characteristics, postoperative outcomes and surgical factors.Ethics and disseminationThis study will not involve human or animal subjects and, thus, does not require ethics approval. The outcomes will be disseminated via publication in peer-reviewed scientific journal(s) and presentations at scientific conferences.PROSPERO registration numberCRD42021256210.

BackgroundNeutropenia and thrombocytopenia are well-recognised complications of systemic chemotherapy. In cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC), the interplay between surgical factors and systemic toxicity of chemotherapeutics must be considered when considering post-operative haematological outcomes. We sought to quantify the incidence of these events in cytoreductive surgery and HIPEC at our institution.MethodsWe conducted a single centre, a retrospective cohort study of 50 consecutive patients who underwent cytoreductive surgery and HIPEC from 2002 to 2015. Routine haematological data were analysed and complications classified according to CTCAE 4.0. Subgroup analysis was undertaken to compare those who received or not perioperative systemic chemotherapy.ResultsThe rate of all-grade post-procedure neutropenia was 4 % (n=2/50); one grade 1, and one grade 4 neutropenia. The patient with grade 4 neutropenia died day 57 post-operatively, despite subsequent growth factor support. Eight percent (n=4/50) of patients had thrombocytopenia preoperatively. The overall rate of post-procedure thrombocytopenia was 46 % with grade 3–4 thrombocytopenia of 4 %. If not present preoperatively, thrombocytopenia onset was on day 1 or 2 post-operatively, with a median duration of 3 days.ConclusionsIntraperitoneal delivery of chemotherapy as HIPEC can cause haematological toxicity with potentially fatal outcomes. However, the incidence of neutropenia and thrombocytopenia after CRS and HIPEC is low.

Background: Colorectal cancer (CRC) diagnosed at

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.

IMPORTANCE: Complex surgical interventions are inherently prone to variation yet they are not objectively measured. The reasons for outcome differences following cancer surgery are unclear. OBJECTIVE: To quantify surgical skill within advanced laparoscopic procedures and its association with histopathological and clinical outcomes. DESIGN, SETTING, AND PARTICIPANTS: This analysis of data and video from the Australasian Laparoscopic Cancer of Rectum (ALaCaRT) and 2-dimensional/3-dimensional (2D3D) multicenter randomized laparoscopic total mesorectal excision trials, which were conducted at 28 centers in Australia, the United Kingdom, and New Zealand, was performed from 2018 to 2019 and included 176 patients with clinical T1 to T3 rectal adenocarcinoma 15 cm or less from the anal verge. Case videos underwent blinded objective analysis using a bespoke performance assessment tool developed with a 62–international expert Delphi exercise and workshop, interview, and pilot phases. INTERVENTIONS: Laparoscopic total mesorectal excision undertaken with curative intent by 34 credentialed surgeons. MAIN OUTCOMES AND MEASURES: Histopathological (plane of mesorectal dissection, ALaCaRT composite end point success [mesorectal fascial plane, circumferential margin, ≥1 mm; distal margin, ≥1 mm]) and 30-day morbidity. End points were analyzed using surgeon quartiles defined by tool scores. RESULTS: The laparoscopic total mesorectal excision performance tool was produced and shown to be reliable and valid for the specialist level (intraclass correlation coefficient, 0.889; 95% CI, 0.832-0.926; P

The aim of the study was to determine the efficacy of laparoscopic rectal resection (Lap) versus open laparotomy and rectal resection (Open) for rectal cancer on locoregional recurrence (LRR) and disease-free survival (DFS) at 2 years.Although a Lap approach to colon cancer surgery may offer similar oncological outcomes to Open with potentially less morbidity, this remains to be clearly established for the treatment of rectal cancer.A randomized, multicenter noninferiority phase 3 trial of 475 patients with T1 to T3 rectal adenocarcinoma15 cm from anal verge, given Lap or Open and followed for a minimum 2 years to assess LRR, DFS, and overall survival (OS).Secondary endpoint analyses included 450 patients (95%) without metastases at baseline (mean age 64; 34% women) who received Lap (n = 225) or Open (n = 225). Median follow-up was 3.2 years (range: 0.1-5.4 yrs). LRR cumulative incidence at 2 years: Lap 5.4%; Open 3.1% [difference, 2.3%; 95% confidence interval (CI), -1.5% to 6.1%; hazard ratio (HR) 1.7; 95% CI, 0.74-3.9]. DFS at 2 years: Lap 80%; Open 82% (difference, 2.0%; 95% CI, -9.3% to 5.4%; HR for recurrence or death, 1.17; 95% CI, 0.81-1.68; P = 0.41). After adjustment for baseline factors HR = 1.07 (95% CI, 0.7-1.6). OS at 2 years: Lap 94%; Open 93% (difference 0.9%; 95% CI, -3.6% to 5.4%).Laparoscopic surgery for rectal cancer did not differ significantly from open surgery in effects on 2-year recurrence or DFS and OS. Confidence intervals included potentially clinically important differences favoring open resection, so that the combination of primary and secondary study endpoints may not support laparoscopic resection of rectal cancer as a routine standard of care and further follow-up is required.

Background Adenoma detection rate (ADR) has shown to be an independent predictor, to reduce the rate of interval colorectal cancer. Endocuff Vision is a relatively new device that has shown promise to improve the ADR. The primary objective was to conduct a randomized controlled trial to compare Endocuff Vision-assisted colonoscopy (EVAC) with standard colonoscopy (SC). The primary outcome of the study is ADR and the secondary outcomes are caecal intubation rate, terminal ileum intubation rate, scope withdrawal time, quality of bowel preparation and adverse events. Methods A randomized controlled trial was performed to compare EVAC versus SC. All patients who presented to the endoscopy suite at the Queen Elizabeth Hospital were assessed for eligibility. Patients were recruited from 15 June 2016 to 20 January 2017. A total of 360 patients were included; 40 were excluded. The patients were randomized using block randomization; 138 patients were recruited to SC and 182 to EVAC. Results A total of 231 polyps were retrieved during the study period. Polyp detection rate (PDR) was high in both groups: 53% in the EVAC group versus 41.1% in SC. This was statistically significant with a P-value of 0.035. ADR was similarly high in both groups: 36.81% in EVAC group versus 28.99% in SC group. ADR did not reach statistical significance. Conclusions EVAC does improve the PDR. Though the ADR did not reach statistical significance, there is a trend towards improved adenoma detection and there is statistical significance in the overall PDR.

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 Transanal haemorrhoidal dearterialization (THD) is increasingly perceived as an effective and better tolerated alternative to excisional haemorrhoidectomy. The aim of this study was to evaluate outcomes and the patient experience of THD in an Australian population with grade III or IV haemorrhoids. Methods A retrospective review of prospectively maintained database on patients who had undergone THD over a 3-year period was performed. Data were collected on demographics, operative data, complications, recurrences and readmissions, postoperative pain and further interventions. Patient perceptions and satisfaction with the procedure were assessed with a telephone survey. Results A total of 85 patients with a mean age of 55 (±14) years with grade III (85%) or grade IV (15%) haemorrhoids underwent THD. Indications for surgery were predominantly bleeding (87%) and prolapse (41%). Median outpatients follow-up was 42 days and median telephone follow-up was 802 days. Median operating time was 25 min (±12). Twenty-four per cent of patients suffered complications, including postoperative bleeding (7%), constipation (7%), local sepsis (6%), anal fissure (5%) and temporary incontinence (2%). Severe postoperative pain occurred in 16% of the patients. The symptom recurrence rate was 19% and reintervention rate was 14%. About 98.8% of patients reported good or excellent overall satisfaction with the procedure. Conclusion THD is a relatively new technique for the treatment of haemorrhoids, which is increasingly being used as an alternative to excisional haemorrhoidectomy. This study shows that patients' satisfaction with THD is high despite a moderate complication and recurrence rate and significant incidence of postoperative pain.

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.

e15005 Background: Colorectal cancer (CRC) is rising in incidence in young adults. Because they are not included in population screening, and are more likely to present at an advanced stage, there is a need to identify young adults at increased risk for CRC. An association has been reported between type 2 diabetes (T2D) and CRC in the general population. Though lifestyle risk factors may be involved, the early occurrence of CRC in young adults suggests that there may also be a role for inherited predispositions. We therefore investigated whether having a personal and/or first-degree family history of T2D was a potential risk marker for early onset CRC. Methods: The South Australian Young Onset (SAYO) CRC study is an unselected series of young adults with CRC up to age 55. Fifty unrelated young adults (31/50 or 62% female) diagnosed with CRC were recruited to the study. Personal history of T2D was confirmed. Detailed family history of T2D was recorded. 253 patients with clear colonoscopies and no known CRC predisposition served as controls for personal history studies of T2D. Diabetes status was recorded on admission for colonoscopy controls. Associations were explored using a chi-squared statistic. Results: CRC patients ranged in age from 23-54 years (median age 42) and controls from 18-54 (median age 45). Six patients (12%) met the WHO clinical criteria for serrated polyposis, and two (4%) carried a Lynch syndrome mutation. CRC was present in the distal colon in 15/19 males (79%) and 17/31 females (55%) (p = 0.12). A personal history of T2D was confirmed in 12/50 (24%) CRC patients compared with clear colonoscopy controls under 55 years (13/258 or 5% P < 0.001; OR = 5.9; 95%CI 2.5-13.8). T2D was seen in 7/31 or 23% females and 5/19 or 26% males. Young adults with CRC frequently reported at least one first-degree relative with T2D (24/47 or 51%). All patients with personal history of T2D also had first-degree relatives with T2D. A first-degree family history of T2D was observed in 12/27 (44%) CRC patients aged under 45 yrs and 12/20 (60%) of CRC patients aged between 45 and 54 yrs having this characteristic (p = 0.29), and was present in both males and females (10/17 or 58% and 13/30 or 43% respectively; p = 0.37). Conclusions: Though the mechanism remains unclear, given the prevalence of T2D in those aged < 55yrs is 5% in Australia, our observations suggest that there is a striking enrichment for personal and first-degree family history of T2D in young adults with CRC. These features could potentially identify a subset of young adults at increased risk for CRC and in whom early screening might be appropriate.

The purpose of this study was to validate the eoSim box laparoscopic simulator using measures of construct, concurrent, and content validity.Forty-seven novice and expert participants were tested on both the Fundamentals of Laparoscopic Surgery (FLS™; Society of American Gastrointestinal and Endoscopic Surgeons, Los Angles, CA) and eoSim (eoSurgical™, Edinburgh, Scotland, United Kingdom) laparoscopic simulators, using established scoring mechanisms. Three skill areas were examined: object transfer, precision cutting, and intracorporeal suturing. A questionnaire was also completed.Experts performed significantly better on the eoSim than novices, with a median score of 51.1% versus 14.8% (P.0001), showing construct validity. There was a high correlation between performance on the validated FLS simulator and the eoSim (0.78; P.0001), demonstrating concurrent validity. Feedback from participants indicated an agreement that the eoSim was a useful training tool providing content validity.The eoSim demonstrates validity as a model for laparoscopic simulation. It is hoped that its decreased cost relative to other simulators will encourage increased uptake by trainees and institutions.

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.

Aim The use of multimedia information provided preoperatively can potentially reduce anxiety in patients and improve the hospital experience. However, the use of two-dimensional (2D) animation (cartoon) to provide information to patients undergoing colorectal surgery has not been investigated. This study investigated the effect of preoperative 2D information on anxiety and knowledge retention in patients undergoing bowel surgery. Method Patients were randomized to one of two groups; the video group watched a 13-min cartoon animation whereas the nonvideo group did not. Anxiety levels were measured at the preadmission clinic, postvideo, on the day of admission for surgery, within 24-h after surgery and before discharge using the Spielberger state-trait anxiety inventory and visual analogue scale. Both groups completed a knowledge retention questionnaire and the video group completed a feedback questionnaire about the animation. Results Thirty-one patients (16 video, 15 nonvideo) participated in the study. There was no significant difference in baseline anxiety score between two groups. An immediate reduction (P = 0.03) in anxiety score was observed in the video group after watching the video compared with baseline. There was a significant reduction in anxiety score in the video group at discharge compared with the nonvideo group (P = 0.03). There was no significant difference in knowledge retention between two groups. Eighty-eight per cent of patients who watched the video found it beneficial. Conclusion 2D animation is an effective medium for delivering information to patients undergoing bowel surgery and can potentially reduce anxiety related to surgery and improve the hospital experience.

Background Antiangiogenic agents have established efficacy in the treatment of metastatic colorectal cancer. We investigated whether bevacizumab could improve disease-free survival in the adjuvant setting after resection of the primary tumour. Methods For the open-label, randomised, controlled QUASAR 2 trial, which was done at 170 hospitals in seven countries, we recruited patients aged 18 years or older with WHO performance status scores of 0 or 1 who had undergone potentially curative surgery for histologically proven stage III or high-risk stage II colorectal cancer. Patients were randomly assigned (1:1) to receive eight 3-week cycles of oral capecitabine alone (1250 mg/m2 twice daily for 14 days followed by a break for 7 days) or the same regimen of oral capecitabine plus 16 cycles of 7·5 mg/kg bevacizumab by intravenous infusion over 90 min on day 1 of each cycle. Randomisation was done by a computer-generated schedule with use of minimisation with a random element stratified by age, disease stage, tumour site, and country. The study was open label and no-one was masked to treatment assignment. The primary endpoint was 3-year disease-free survival, assessed in the intention-to-treat population. Toxic effects were assessed in patients who received at least one dose of randomised treatment. This trial is registered with the ISRCTN registry, number ISRCTN45133151. Findings Between April 25, 2005, and Oct 12, 2010, 1952 eligible patients were enrolled, of whom 1941 had assessable data (968 in the capecitabine alone group and 973 in the capecitabine and bevacizumab group). Median follow-up was 4·92 years (IQR 4·00–5·16). Disease-free survival at 3 years did not differ between the groups (75·4%, 95% CI 72·5–78·0 in the capecitabine and bevacizumab group vs 78·4%, 75·7–80·9 in the capecitabine alone group; hazard ratio 1·06, 95% CI 0·89–1·25, p=0·54). The most common grade 3–4 adverse events were hand–foot syndrome (201 [21%] of 963 in the capecitabine alone group vs 257 [27%] of 959 in the capecitabine and bevacizumab group) and diarrhoea (102 [11%] vs 104 [11%]), and, with the addition of bevacizumab, expected increases were recorded in all-grade hypertension (320 [33%] vs 75 [8%]), proteinuria (197 [21%] vs 49 [5%]), and wound healing problems (30 [3%] vs 17 [2%]). 571 serious adverse events were reported (221 with capecitabine alone and 350 with capecitabine and bevacizumab). Most of these were gastrointestinal (n=245) or cardiovascular (n=169). 23 deaths within 6 months of randomisation were classified as being related to treatment, eight in the capecitabine alone group and 15 in the capecitabine and bevacizumab group. Interpretation The addition of bevacizumab to capecitabine in the adjuvant setting for colorectal cancer yielded no benefit in the treatment of an unselected population and should not be used.

Aims To determine whether the addition of additional cycles of chemotherapy during the “wait “period following neoadjuvant chemo-radiotherapy for rectal cancer improves the pathologic complete response rate (pCR). Methods Rectal cancer patients were randomly allocated to either a standard 10 week wait period before surgery (standard chemo-radiotherapy, SCRT) or to receive 3 cycles of 5FU based chemotherapy following chemo-radiotherapy during a similar 10 week wait (extended chemo-radiotherapy, XCRT). Primary endpoint was pCR as determined by blinded pathologic assessment. Results Forty nine patients were randomized (SCRT n =24, XCRT n = 25). Pathologic complete response (pCR) occurred in 10 patients overall but there was no significant difference in pCR between the groups (SCRT n = 6, XCRT n = 4 p = 0.49). Conclusion The addition of 3 cycles of 5FU/LV in a 10 week wait period after conventional chemoradiotherapy seems to result in similar pCR rates in patients with locally advanced rectal cancer based on this small randomized trial. This article is protected by copyright. All rights reserved.

Background Several recent studies have suggested that warming up prior to surgery may improve surgical performance. The purpose of this study was to investigate whether warming up prior to laparoscopic surgery improves surgical performance or reduces surgery duration. Methods Between August 2011 and January 2012, a randomized controlled trial was conducted to compare two warm-up modalities to no warm-up. The study was conducted at a single site, with nine surgeons performing 72 laparoscopic cholecystectomies and 37 laparoscopic appendicectomies. Prior to surgery, surgeons were randomized to either laparoscopic trainer box warm-up, PlayStation 2 warm-up or no warm-up. The activity was performed within 30 min of surgery commencing. Patients provided informed consent for the surgery to be digitally recorded. Digital videodiscs (DVDs) were reviewed by an independent and blinded assessor. Data were collected on duration of surgery, level of training and perceived surgical difficulty. Surgical performance was graded using a validated scoring system. Results From the 109 operations performed, there were 75 usable DVDs. Overall, there were no statistical differences in the demographics of patients and surgeons in the three treatment groups, nor in the subset that had useable DVDs. There were no statistical differences in the duration of surgery or surgeon's perceived surgical difficulty. There was no statistical difference in surgical performance. Conclusions This study suggests that warm-up prior to laparoscopic cholecystectomy or appendicectomy is not essential, acknowledging that there are several study limitations that preclude definitive conclusion.

Background: Previous randomized studies have compared high- versus low-fidelity laparoscopic simulators; however, no proficiency criteria were defined and results have been mixed. The purpose of this research was to determine whether there were any differences in the learning outcomes of participants who had trained to proficiency on low- or high-fidelity laparoscopic surgical simulators. Methods: We conducted a randomized, prospective crossover trial with participants recruited from New South Wales, Western Australia, and South Australia. Participants were randomized to high-fidelity (LapSim, Surgical Science) or low-fidelity (FLS, SAGES) laparoscopic simulators and trained to proficiency in a defined number of tasks. They then crossed over to the other fidelity simulator and were tested. The outcomes of interest were the crossover mean scores, the proportion of tasks passed, and percentage passes for the crossover simulator tasks. Results: Of the 228 participants recruited, 100 were randomized to LapSim and 128 to FLS. Mean crossover score increased from baseline for both simulators, but there was no significant difference between them (11.0 % vs. 11.9 %). FLS-trained participants passed a significantly higher proportion of crossover tasks compared with LapSim-trained participants (0.26 vs. 0.20, p = 0.016). A significantly higher percentage of FLS-trained participants passed intracorporeal knot tying than LapSim-trained participants (35 % vs. 8 %, p < 0.001). Conclusion: Similar increases in participant score from baseline illustrate that training on either simulator type is beneficial. However, FLS-trained participants demonstrated a greater ability to translate their skills to successfully complete LapSim tasks. The ability of FLS-trained participants to transfer their skills to new settings suggests the benefit of this simulator type compared with the LapSim. Refereed/Peer-reviewed

Background: Restoration of bowel continuity after a temporary loop ileostomy following rectal resection often produces impaired bowel function. The purpose of this clinical trial was to assess the efficacy of a probiotic, VSL#3 (VSL Pharmaceuticals Inc., Gaithersburg, MD, USA), in improving bowel function following ileostomy closure. Methods: Between March 2005 and April 2008, a prospective, double-blind, placebo-controlled randomized trial of a probiotic preparation was conducted across four South Australian hospitals. Sixty-three patients who underwent a loop ileostomy reversal were randomized to receive 4-week treatment of either probiotic therapy (n= 31) or placebo (n= 32). Bowel symptomology was collected through a patient-completed bowel diary and the Gastrointestinal Quality of Life Index (GIQLI). Results: Completion rates of the 4-week therapy regime were similar for both groups: 18 active versus 20 placebos. There was no statistically significant difference in the number of patients who withdrew or had adverse events in the two treatment groups. Reasons for patient withdrawal from the study were similar for both groups. Repeated measures analysis of variance showed no statistically significant difference between the GIQLI scores for the two treatment groups. Conclusions: The use of the probiotic preparation, VSL#3, did not alter the post-operative bowel function of patients undergoing loop ileostomy reversal.

Aim The issue of cost effectiveness of laparoscopic surgery remains uncertain and its impact on the ward nursing staff is unaddressed. This study investigated these issues using patients from a single centre admitted to a randomized controlled trial. Method All patients recruited into the Australasian Laparoscopic Colon Cancer Study (ALCCaS) from The Queen Elizabeth Hospital between January 1999 and March 2005 were included in this study. Data relating to hospital cost were collated from the Hospital Patient Costing System. Nursing interventions were calculated in minutes per patient, using the excelcare Software database. Results Data from 97 patients were analysed (laparoscopy, 53; open surgery, 44). The median number of hours of nursing input per patient was 80 (27.5–907) h in the open surgery group and 58.5 (15–684.5) h in the laparoscopy group. This difference was further increased after exclusion of patients converted from laparoscopy to open surgery. The median total cost of the procedure was AUS$9698/£5631 (AUS$3862–90 397) in the open surgery group and AUS$10 951/£6219 (AUS$2337–66 237) in the laparoscopy group. Conclusion These data suggest that laparoscopic colorectal surgery is equivalent in price to open surgery and there may be added benefits in reduced nursing intensity.

Lana Sturm, Drew Dawson, Richard Vaughan, Peter Hewett, Andrew G. Hill, John C. Graham and Guy J. Maddern

Background: This paper describes the distinctions between major surgical and pharmaceutical trials and questions the application of a common ethical paradigm to guide their conduct and reporting. Methods: Surgical trials differ from other trials in cumulative therapeutic effects, operator dependence, the clinical setting, interdependence of short- and long-term outcomes, and equipoise. A principal tenant of randomized controlled trial management is the maintenance of interim data confidentiality. Its application to complete surgical short-term data is examined across a variety of common clinical trial circumstances that influence data integrity and the reliability of conclusions regarding the benefit-to-risk profile of experimental interventions. Results: Complete perioperative results describe important treatment ends that cannot influence primary outcomes. These short-term results may inform patient consent, teaching and provide valuable procedural insights to surgeons outside trial precincts. Conclusion: Structured experimentation standards are necessary. But, the common paradigm applied across all clinical trials and the prohibition on short term data reporting may not serve the achievement of safe and effective advancements in surgery.

Laparoscopic and minimally invasive surgery has changed the surgical landscape irrevocably. Natural orifice translumenal endoscopic surgery (NOTES) offers the possibility of surgery without visible scars. Transvaginal entry offers potential benefits because it gains access to the peritoneal cavity without the need to open an abdominal viscus. Much of the discussion pertaining to NOTES focuses on technical and training issues, with little attention to date paid to the opinions of women. The perceptions of female health care workers and patients were sought in relation to their views on transvaginal NOTES. This study surveyed 300 women using a 12-point questionnaire devised by a multidisciplinary group of surgeons interested in minimally invasive surgery. The questionnaire was designed to establish the opinions of women with respect to NOTES surgery versus standard laparoscopic procedures. Responses were de-identified. Three-fourths of the women surveyed were neutral or unhappy about the prospect of a NOTES procedure, and this remained constant even when it was stipulated that laparoscopic cholecystectomy and NOTES had equivalent safety and efficacy. Younger nulliparous women were most concerned about the potential negative effect of NOTES on sexual function. A minority were concerned about the cosmetic effect of surgery, although surgical scars were perceived as more important to younger respondents. Potentially, NOTES surgery offers women a scarless operation with the possibility of less pain than experienced in standard laparoscopic surgery. Few women, however, were troubled about the cosmetic effect of surgery. The effect of NOTES on sexual function was expressed as a particular concern by younger women. In all groups and across all ages, peritoneal access using the transvaginal route was met by significant scepticism. In Australia, women remain to be convinced about the potential advantages of the emerging NOTES technology.

Purpose: The primary objectives of this trial were to evaluate the safety and feasibility of treatment and to gain a preliminary indication of the effectiveness of ethylene vinyl alcohol injections into the anal sphincters of faecally incontinent patients. Methods: Between April 2004 and February 2006, we conducted a prospective, single-arm, procedure optimization study of ethylene vinyl alcohol injections in 21 subjects with well-characterized faecal incontinence and an intact external anal sphincter at two Australian hospitals. Results: There was a significant decrease in the Cleveland Clinic Florida Faecal Incontinence Score (CCFFIS) (P= 0.0005) and the Faecal Incontinence Severity Index score (P= 0.005) after treatment. At 12 months post-treatment, the mean CCFFIS had decreased by 37% (P= 0.0021), and 47% of subjects had a ≥50% improvement in CCFFIS. There were significant improvements in embarrassment (P= 0.0455) and coping/behaviour (P= 0.0056) domains of the Faecal Incontinence Quality of Life. At 12 months, the mean anal canal length had increased by 29% (P= 0.066), with 40% of patients demonstrating increases of 50% or more. There were no further improvements following retreatment. Conclusions: Ethylene vinyl alcohol injection into the anal intersphincteric plane is feasible and well tolerated. Improvement in faecal incontinence compared with baseline was seen. Retreating initial non-responders was not successful.

Background A retrospective analysis of age-related postoperative morbidity in the Australia and New Zealand prospective randomized controlled trial comparing laparoscopic and open resection for right- and left-sided colonic cancer is presented. Methods A total of 592 eligible patients were entered and studied from 1998 to 2005. Results Data from 294 patients who underwent laparoscopic and 298 who had open colonic resection were analysed; 266 patients were aged less than 70 years and 326 were 70 years or older (mean(s.d.) 70·3(11·0) years). Forty-three laparoscopic operations (14·6 per cent) were converted to an open procedure. Fewer complications were reported for intention-to-treat laparoscopic resections compared with open procedures (P = 0·002), owing primarily to a lower rate in patients aged 70 years or more (P = 0·002). Fewer patients in the laparoscopic group experienced any complication (P = 0·035), especially patients aged 70 years or above (P = 0·019). Conclusion Treatment choices for colonic cancer depend principally upon disease-free survival; however, patients aged 70 years or over should have rigorous preoperative investigation to avoid conversion and should be considered for laparoscopic colonic resection. Registration number: NCT00202111 (http://www.clinicaltrials.gov).

This article describes the initiation and implementation of the multicentre Australia and New Zealand prospective randomized controlled clinical study comparing laparoscopic and conventional open surgical treatments of right-sided and left-sided potentially curable colon cancer ( Australasian Laparoscopic Colon Cancer Study). Six hundred and one adult patients were admitted with a clinical diagnosis of a single adenocarcinoma based on a physical examination and colonoscopy, barium enema or computed tomography scan and randomly allocated to either laparoscopic or open surgery. The primary aim of the study is to compare 5-year mortality and tumour recurrence rates between the two groups. Secondary aims include comparisons of safety (intraoperative and early postoperative complications, wound site recurrence, postoperative recovery and 30-day mortality), quality of life, in-hospital costs and short-term mortality and tumour recurrence. The data for 592 patients have been collected. There are currently 3141 person years of follow up. In all 370 patients have been assessed at 5 years. This study shows that large cooperative Australia-New Zealand surgical trials can and should be carried out to address significant clinical issues. When possible, coherence with similar, concurrent international trial protocols ensures broader analyses and applicability of results. It is important to recognize that special attention to sustained funding, surgeon credentialing, clinical protocol standardization, data management, publication policy and the protection of study credibility is required from the outset. The Australasian Laparoscopic Colon Cancer Study will achieve its aims with 5-year assessments of all entered patients in March 2010.

Objective: To determine whether skills acquired by simulationbased training transfer to the operative setting. Summary Background Data: The fundamental assumption of simulation-based training is that skills acquired in simulated settings are directly transferable to the operating room, yet little evidence has focused on correlating simulated performance with actual surgical performance. Methods: A systematic search strategy was used to retrieve relevant studies. Inclusion of articles was determined using a predetermined protocol, independent assessment by 2 reviewers, and a final consensus decision. Only studies that reported on the use of simulationbased training for surgical skills training, and the transferability of these skills to the operative setting, were included. Results: Ten randomized controlled trials and 1 nonrandomized comparative study were included in this review. In most cases, simulation-based training was in addition to normal training programs. Only 1 study compared simulation-based training with patient-based training. For laparoscopic cholecystectomy and colonoscopy/sigmoidoscopy, participants who received simulation-based training before undergoing patient-based assessment performed better than their counterparts who did not receive previous simulation training, but improvement was not demonstrated for all measured parameters. Conclusions: Skills acquired by simulation-based training seem to be transferable to the operative setting. The studies included in this review were of variable quality and did not use comparable simulation-based training methodologies, which limited the strength of the conclusions. More studies are required to strengthen the evidence base and to provide the evidence needed to determine the extent to which simulation should become a part of surgical training programs. (Ann Surg 2008;248: 166‐179)

Circulating tumor cells (CTC) may be defined as tumor- or metastasis-derived cells that are present in the bloodstream. The CTC pool in colorectal cancer (CRC) patients may include not only epithelial tumor cells, but also tumor cells undergoing epithelial-mesenchymal transition (EMT) and tumor stem cells. A significant number of patients diagnosed with early stage CRC subsequently relapse with recurrent or metastatic disease despite undergoing "curative" resection of their primary tumor. This suggests that an occult metastatic disease process was already underway, with viable tumor cells being shed from the primary tumor site, at least some of which have proliferative and metastatic potential and the ability to survive in the bloodstream. Such tumor cells are considered to be responsible for disease relapse in these patients. Their detection in peripheral blood at the time of diagnosis or after resection of the primary tumor may identify those early-stage patients who are at risk of developing recurrent or metastatic disease and who would benefit from adjuvant therapy. CTC may also be a useful adjunct to radiological assessment of tumor response to therapy. Over the last 20 years many approaches have been developed for the isolation and characterization of CTC. However, none of these methods can be considered the gold standard for detection of the entire pool of CTC. Recently our group has developed novel unbiased inertial microfluidics to enrich for CTC, followed by identification of CTC by imaging flow cytometry. Here, we provide a review of progress on CTC detection and clinical significance over the last 20 years. Refereed/Peer-reviewed

Three-dimensional (3D) laparoscopes have been developed to maintain the perception of depth in the operating field. Two-dimensional (2D) imaging relies on tactile feedback, visual cues, and previous experience. The aim of this study was to test if 3D laparoscopic vision is superior to 2D laparoscopic vision in training novice operators in completing set laparoscopic tasks.The study population consisted of 20 interns and medical students. The participants were randomized to completing tasks using a 2D or 3D system. These included pegboard transfer (PT), continuous suturing (CS), and intracorporeal knot-tying (IK). The time to complete the task and number of errors made were recorded.Following adjustment for potential confounders, time to complete CS and IK was significantly longer among participants who used the 2D laparoscope compared with those who used the 3D laparoscope (CS, P.0001; IK, P.0001). This same effect was not demonstrated in time to perform PT (PT, P=.04). The 2D laparoscope was associated with a significant increase in the number of errors on the IK task (P.0001) but not on the PT or CS tasks (PT, P=.35; CS, P=.26).The 3D system assists novice operators perform more complex laparoscopic tasks in a decreased amount of time and with fewer errors.