Dr Peter Pockney

BACKGROUND Patients undergoing surgery with perioperative COVID-19 are suggested to have worse outcomes, but whether this is COVID-related or due to selection bias remains unclear. We aimed to compare the postoperative outcomes of patients with and without perioperative COVID-19. METHODS Patients with perioperative COVID-19 diagnosed within 7 days before or 30 days after surgery between February and July 2020 from 68 US hospitals in COVIDSurg, an international multicenter database, were 1:1 propensity score matched to patients without COVID-19 undergoing similar procedures in the 2012 American College of Surgeons National Surgical Quality Improvement Program database. The matching criteria included demographics (e.g., age, sex), comorbidities (e.g., diabetes, chronic obstructive pulmonary disease, chronic kidney disease), and operation characteristics (e.g., type, urgency, complexity). The primary outcome was 30-day hospital mortality. Secondary outcomes included hospital length of stay and 13 postoperative complications (e.g., pneumonia, renal failure, surgical site infection). RESULTS A total of 97,936 patients were included, 1,054 with and 96,882 without COVID-19. Prematching, COVID-19 patients more often underwent emergency surgery (76.1% vs. 10.3%, p < 0.001). A total of 843 COVID-19 and 843 non-COVID-19 patients were successfully matched based on demographics, comorbidities, and operative characteristics. Postmatching, COVID-19 patients had a higher mortality (12.0% vs. 8.1%, p = 0.007), longer length of stay (6 [2-15] vs. 5 [1-12] days), and higher rates of acute renal failure (19.3% vs. 3.0%, p < 0.001), sepsis (13.5% vs. 9.0%, p = 0.003), and septic shock (11.8% vs. 6.0%, p < 0.001). They also had higher rates of thromboembolic complications such as deep vein thrombosis (4.4% vs. 1.5%, p < 0.001) and pulmonary embolism (2.5% vs. 0.4%, p < 0.001) but lower rates of bleeding (11.6% vs. 26.1%, p < 0.001). CONCLUSION Patients undergoing surgery with perioperative COVID-19 have higher rates of 30-day mortality and postoperative complications, especially thromboembolic, compared with similar patients without COVID-19 undergoing similar surgeries. Such information is crucial for the complex surgical decision making and counseling of these patients. LEVEL OF EVIDENCE Prognostic and Epidemiologic; Level IV.

Background: Emergency laparotomy (EL) is performed on about 15 500 patients in Australia each year. Aside from mortality there is significant concern about the possibility that previously independent patients discharged after EL will become reliant on long-term dependent care. This study aimed to establish the proportion of patients not returning to their pre-admission residence, a proxy for dependent care, following EL. Methods: Data were collected on all adult patients who underwent EL across four Australian hospitals over 2 years. A total of 113 data points were collected including pre-hospital residence, discharge destination, mortality and place of residence at 90 and 365 days. Results: A total of 782 patients underwent EL, the mean age was 64 years. Pre-admission, 95.5% of patients were living in their own home. Inpatient mortality was 7.0% and at discharge 72.4% of patients returned directly back to their pre-hospital residence. At 90 days, mortality was 10.5%, and 87% of patients had returned to their pre-hospital residence, including all patients under 70 years of age. By 365 days, overall mortality was 16.8%, and only 1.5% of patients (all aged >70 years) had not returned to their pre-hospital residence. Conclusion: Patients who survive 90 and 365 days following EL nearly all return to their pre-hospital residence, with only a very small proportion of previously independent patients entering dependent care. This should help inform shared decision-making regarding emergency laparotomy in the acute setting.

The collaborative research model is a powerful approach to answering surgical research questions that empowers and inspires medical students and trainees. The Opioid PrEscRiptions and usage After Surgery (OPERAS) study is a student- and trainee-led international multi-centre prospective cohort study developed in Australia and Aotearoa New Zealand. In this article, we will discuss (i) how the OPERAS study was conceptualized and structured; (ii) the channels through which information and education were communicated to collaborators; (iii) how data was stored in a secure and user-friendly fashion and (iv) the lessons learned and expected goals for the future. We aim to describe how collaborative research studies can be designed to support early career researchers to make valuable contributions to the literature.

Aim: Intraperitoneal drains are often placed during emergency colorectal surgery. However, there is a lack of evidence supporting their use. This study aimed to describe the efficacy and safety of intraperitoneal drain placement after emergency colorectal surgery. Method: COMPlicAted intra-abdominal collectionS after colorectal Surgery (COMPASS) is a prospective, international, cohort study into which consecutive adult patients undergoing emergency colorectal surgery were enrolled (from 3 February 2020 to 8 March 2020). The primary outcome was the rate of intraperitoneal drain placement. Secondary outcomes included rate and time-to-diagnosis of postoperative intraperitoneal collections, rate of surgical site infections (SSIs), time to discharge and 30-day major postoperative complications (Clavien¿Dindo III¿V). Multivariable logistic and Cox proportional hazards regressions were used to estimate the independent association of the outcomes with drain placement. Results: Some 725 patients (median age 68.0 years; 349 [48.1%] women) from 22 countries were included. The drain insertion rate was 53.7% (389 patients). Following multivariable adjustment, drains were not significantly associated with reduced rates (odds ratio [OR] = 1.56, 95% CI: 0.48¿5.02, p = 0.457) or earlier detection (hazard ratio [HR] = 1.07, 95% CI: 0.61¿1.90, p = 0.805) of collections. Drains were not significantly associated with worse major postoperative complications (OR = 1.26, 95% CI: 0.67¿2.36, p = 0.478), delayed hospital discharge (HR = 1.11, 95% CI: 0.91¿1.36, p = 0.303) or increased risk of SSIs (OR = 1.61, 95% CI: 0.87¿2.99, p = 0.128). Conclusion: This is the first study investigating placement of intraperitoneal drains following emergency colorectal surgery. The safety and clinical benefit of drains remain uncertain. Equipoise exists for randomized trials to define the safety and efficacy of drains in emergency colorectal surgery.

Australia¿s National Bowel Cancer Screening Program (NBCSP) has the potential to prevent almost 84 000 bowel cancer deaths if 60% program participation rates could be reached and maintained over the next two decades. Immunochemical faecal occult blood test (iFOBT) is used as an initial screening tool. Participants who test positive are referred for colonoscopy for diagnostic assessment. Concerns about colonoscopy capacity and lengthy wait times between positive iFOBT and colonoscopy have hampered efforts to promote the program. However, a separate research paper published in this issue of PHRP shows that only an estimated 10¿14% of Medicare-funded colonoscopies (almost 75% of all colonoscopies) in Australia are generated by the NBCSP. Inappropriate use of colonoscopy as a primary screening tool and failure to prioritise NBCSP participants may be the main reasons for long colonoscopy wait times associated with the program. Promoting clinical practice guidelines, and the Direct Access Colonoscopy initiative for priority patients, are key to reducing colonoscopy wait times and proactive promotion of the NBCSP.

Background: Surgical Site Infection (SSI) of the abdominal incision is a dreaded complication following colorectal surgery. Identifying the intraoperative surgical site microbes may provide clarity in the pathogenesis of SSIs. Genomic sequencing has revolutionized the ability to identify microbes from clinical samples. Utilization of 16S rRNA amplicon sequencing to characterize the intraoperative surgical site may provide the critical information required to predict and prevent infection in colorectal surgery. Methods: This is a pilot, prospective observational study of 50 patients undergoing elective colorectal resection. At completion of surgery, prior to skin closure, swabs were taken from the subcutaneous tissue of the abdominal incision to investigate the microbial profile. Dual swabs were taken to compare standard culture technique and 16S rRNA sequencing to establish if a microbial profile was associated with postoperative SSI. Results: 8/50 patients developed an SSI, which was more likely in those undergoing open surgery (5/15 33.3% versus 3/35, 8.6%; P = 0.029). 16S rRNA amplicon sequencing was more sensitive in microbial detection compared to traditional culture. Both culture and 16S rRNA demonstrated contamination of the surgical site, predominantly with anaerobes. Culture was not statistically predictive of infection. 16S rRNA amplicon sequencing was not statistically predictive of infection, however, it demonstrated patients with an SSI had an increased biodiversity (not significant) and a greater relative abundance (not significant) of pathogens such as Bacteroidacaea and Enterobacteriaceae within the intraoperative site. Conclusions: 16S rRNA amplicon sequencing has demonstrated a potential difference in the intraoperative microbial profile of those that develop an infection. These findings require validation through powered experiments to determine the overall clinical significance.

Background: WHO and the UK's National Institute for Health and Care Excellence recommend alcoholic chlorhexidine skin preparation and triclosan-coated sutures to prevent surgical site infections (SSIs). Existing meta-analyses that include studies at high risk of bias, combined with the recent publication of large, randomised trials, justify an updated meta-analysis of high-quality randomised controlled trials (RCTs). We aimed to test the rates of SSI according to skin preparation solutions (ie, alcoholic chlorhexidine vs aqueous povidone-iodine) and types of sutures (ie, coated vs uncoated). Methods: In this systematic review and meta-analysis, we searched MEDLINE, Embase, Pubmed, and Cochrane Library databases, with no language restrictions, to identify high-quality RCTs testing either alcoholic chlorhexidine skin preparation (vs aqueous povidone-iodine) or triclosan-coated sutures (vs uncoated sutures), or both, published from database inception to Sept 1, 2021. Patients who received clean-contaminated, contaminated, or dirty surgery were included. We predefined the characteristics of a high-quality trial through an expert consensus process to develop an enhanced Cochrane risk of bias-2 tool specifically for RCTs with a primary outcome of SSI. Data were extracted from published reports. Meta-analysis was performed using a random-effects model and heterogeneity was assessed using the I2 statistic. This systematic review and meta-analysis was prospectively registered in PROSPERO, CRD42021267220. Findings: Of 942 studies identified, 933 were excluded. Four high-quality RCTs (n=7467 patients) were included that tested alcoholic chlorhexidine. No significant difference in SSI rates was noted between alcoholic chlorhexidine and aqueous povidone-iodine (17·9% [667 of 3723 patients] vs 19·8% [740 of 3744 patients]; odds ratio 0·84 [95% CI 0·65¿1·06]; p=0·21, I2=53·1%). Five high-quality RCTs were included that tested triclosan-coated sutures (n=8619 patients), with no significant difference noted between triclosan-coated and uncoated sutures (16·8% [733 of 4360 patients] vs 18·4% [784 of 4259 patients]; OR 0·90 [95% CI 0·74¿1·09]; p=0·29, I2=36·4%). Interpretation: Contrary to previous meta-analyses, this study did not show a benefit from either alcoholic chlorhexidine skin preparation or triclosan-coated sutures, both of which are more expensive than other readily available alternatives. Global and national guidance should be reconsidered to remove recommendations for their routine use. Funding: National Institute for Health Research (NIHR) Global Health Research Unit.

Aim: Adhesive small bowel obstruction (ASBO) is a common surgical emergency condition. Research in the field is plentiful; however, inconsistency in outcome reporting makes comparisons challenging. The aim of this study was to define a core outcome set (COS) for studies of ASBO. Methods: The long list of outcomes was identified through systematic review, and focus groups across different geographical regions. A modified Delphi consensus exercise of three rounds was undertaken with stakeholder groups (patients and clinicians). Items were rated on a 9-point Likert scale. Items exceeding 70% rating at 7¿9 were passed to the consensus meeting. New item proposals were invited in round 1. Individualised feedback on prior voting compared to other participants was provided. An international consensus meeting was convened to ratify the final COS. Results: In round 1, 56 items were rated by 118 respondents. A total of 18 items reached consensus, and respondents proposed an additional 10 items. Round 2 was completed by 90 respondents, and nine items achieved consensus. In round 3, 80 surveys were completed; one item achieved consensus, and five borderline items were identified. The final COS included 26 outcomes, mapped to the following domains: Interventions, need for stoma, septic complications, return of gut function, patient reported outcomes, and recurrence of obstruction, as well as mortality, failure to rescue, and time to resolution. Conclusion: This COS should be used in future studies in the treatment of adhesive SBO. Further studies to define a core measurement set are needed to identify the optimum tools to measure each outcome.

Background: Early death after cancer surgery is higher in low-income and middle-income countries (LMICs) compared with in high-income countries, yet the impact of facility characteristics on early postoperative outcomes is unknown. The aim of this study was to examine the association between hospital infrastructure, resource availability, and processes on early outcomes after cancer surgery worldwide. Methods: A multimethods analysis was performed as part of the GlobalSurg 3 study¿a multicentre, international, prospective cohort study of patients who had surgery for breast, colorectal, or gastric cancer. The primary outcomes were 30-day mortality and 30-day major complication rates. Potentially beneficial hospital facilities were identified by variable selection to select those associated with 30-day mortality. Adjusted outcomes were determined using generalised estimating equations to account for patient characteristics and country-income group, with population stratification by hospital. Findings: Between April 1, 2018, and April 23, 2019, facility-level data were collected for 9685 patients across 238 hospitals in 66 countries (91 hospitals in 20 high-income countries; 57 hospitals in 19 upper-middle-income countries; and 90 hospitals in 27 low-income to lower-middle-income countries). The availability of five hospital facilities was inversely associated with mortality: ultrasound, CT scanner, critical care unit, opioid analgesia, and oncologist. After adjustment for case-mix and country income group, hospitals with three or fewer of these facilities (62 hospitals, 1294 patients) had higher mortality compared with those with four or five (adjusted odds ratio [OR] 3·85 [95% CI 2·58¿5·75]; p<0·0001), with excess mortality predominantly explained by a limited capacity to rescue following the development of major complications (63·0% vs 82·7%; OR 0·35 [0·23¿0·53]; p<0·0001). Across LMICs, improvements in hospital facilities would prevent one to three deaths for every 100 patients undergoing surgery for cancer. Interpretation: Hospitals with higher levels of infrastructure and resources have better outcomes after cancer surgery, independent of country income. Without urgent strengthening of hospital infrastructure and resources, the reductions in cancer-associated mortality associated with improved access will not be realised. Funding: National Institute for Health and Care Research.

Background: Stratifying risk of postoperative pulmonary complications after major abdominal surgery allows clinicians to modify risk through targeted interventions and enhanced monitoring. In this study, we aimed to identify and validate prognostic models against a new consensus definition of postoperative pulmonary complications. Methods: We did a systematic review and international external validation cohort study. The systematic review was done in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We searched MEDLINE and Embase on March 1, 2020, for articles published in English that reported on risk prediction models for postoperative pulmonary complications following abdominal surgery. External validation of existing models was done within a prospective international cohort study of adult patients (=18 years) undergoing major abdominal surgery. Data were collected between Jan 1, 2019, and April 30, 2019, in the UK, Ireland, and Australia. Discriminative ability and prognostic accuracy summary statistics were compared between models for the 30-day postoperative pulmonary complication rate as defined by the Standardised Endpoints in Perioperative Medicine Core Outcome Measures in Perioperative and Anaesthetic Care (StEP-COMPAC). Model performance was compared using the area under the receiver operating characteristic curve (AUROCC). Findings: In total, we identified 2903 records from our literature search; of which, 2514 (86·6%) unique records were screened, 121 (4·8%) of 2514 full texts were assessed for eligibility, and 29 unique prognostic models were identified. Nine (31·0%) of 29 models had score development reported only, 19 (65·5%) had undergone internal validation, and only four (13·8%) had been externally validated. Data to validate six eligible models were collected in the international external validation cohort study. Data from 11 591 patients were available, with an overall postoperative pulmonary complication rate of 7·8% (n=903). None of the six models showed good discrimination (defined as AUROCC =0·70) for identifying postoperative pulmonary complications, with the Assess Respiratory Risk in Surgical Patients in Catalonia score showing the best discrimination (AUROCC 0·700 [95% CI 0·683¿0·717]). Interpretation: In the pre-COVID-19 pandemic data, variability in the risk of pulmonary complications (StEP-COMPAC definition) following major abdominal surgery was poorly described by existing prognostication tools. To improve surgical safety during the COVID-19 pandemic recovery and beyond, novel risk stratification tools are required. Funding: British Journal of Surgery Society.

Background: Somatic disorders and somatic symptoms are common in primary care populations; however, little is known about the prevalence in surgical populations. Identification of inpatients with high somatic symptom burden and psychological co-morbidity could improve access to effective psychological therapies. Methods: Cross-sectional analysis (n = 465) from a prospective longitudinal cohort study of consecutive adult admissions with non-traumatic abdominal pain, at a tertiary hospital in New South Wales, Australia. We estimated somatic symptom prevalence with the Patient Health Questionnaire-15 at three cut-points: moderate (¿10), severe (¿15) and ¿bothered a lot¿ on ¿3 symptoms; and psychological co-morbidity with the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 at standard (¿10) cut-points. We also examined gender differences for somatic symptoms and psychological co-morbidity. Results: Prevalence was moderate (52%), female predominance (odds ratio = 1.71; 95% confidence interval = [1.18, 2.48]), severe (20%), no gender difference (1.32; [0.83, 2.10]) and ¿bothered a lot¿ on ¿3 symptoms (53%), female predominance (2.07; [1.42, 3.03]). Co-morbidity of depressive, anxiety and somatic symptoms ranged from 8.2% to 15.9% with no gender differences. Conclusion: Somatic symptoms were common and psychological triple co-morbidity occurred in one-sixth of a clinical population admitted for abdominal pain. Co-ordinated surgical and psychological clinical intervention and changes in clinical service organisation may be warranted to provide optimal care.

PURPOSE As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19¿free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19¿free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19¿free surgical pathways. Patients who underwent surgery within COVID-19¿free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19¿free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score¿matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19¿free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION Within available resources, dedicated COVID-19¿free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks.

Purpose: Natural Killer (NK) cells are a vital part of immune surveillance and have been implicated in colorectal cancer development and prognosis. This systematic review aims to distil the literature on NK cells as it relates to colorectal cancer. Methods: All published studies over 10¿years relating to NK cells and colorectal cancer were reviewed. All studies publishing in English, searchable via pubmed or through reference review and reporting directly on the nature or function of NK cells in colorectal cancer patients were included. Outcomes were determined as alterations or new information regarding NK cells in colorectal cancer patients. Results: Natural killer cells may be implicated in the development of colorectal cancer and may play a role in prognostication of the disease. NK cells are altered by the treatment (both surgical and medical) of colorectal cancer and it seems likely that they will also be a target for manipulation to improve colorectal cancer survival. Conclusions: NK cell morphology and function are significantly affected by the development of colorectal cancer. Observation of NK cell changes may lead to earlier detection and better prognostication in colorectal cancer. Further study is needed into immunological manipulation of NK cells which may lead to improved colorectal cancer survival.

Background: The aims of this study were to provide data on the safety of head and neck cancer surgery currently being undertaken during the coronavirus disease 2019 (COVID-19) pandemic. Methods: This international, observational cohort study comprised 1137 consecutive patients with head and neck cancer undergoing primary surgery with curative intent in 26 countries. Factors associated with severe pulmonary complications in COVID-19¿positive patients and infections in the surgical team were determined by univariate analysis. Results: Among the 1137 patients, the commonest sites were the oral cavity (38%) and the thyroid (21%). For oropharynx and larynx tumors, nonsurgical therapy was favored in most cases. There was evidence of surgical de-escalation of neck management and reconstruction. Overall 30-day mortality was 1.2%. Twenty-nine patients (3%) tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 30 days of surgery; 13 of these patients (44.8%) developed severe respiratory complications, and 3.51 (10.3%) died. There were significant correlations with an advanced tumor stage and admission to critical care. Members of the surgical team tested positive within 30 days of surgery in 40 cases (3%). There were significant associations with operations in which the patients also tested positive for SARS-CoV-2 within 30 days, with a high community incidence of SARS-CoV-2, with screened patients, with oral tumor sites, and with tracheostomy. Conclusions: Head and neck cancer surgery in the COVID-19 era appears safe even when surgery is prolonged and complex. The overlap in COVID-19 between patients and members of the surgical team raises the suspicion of failures in cross-infection measures or the use of personal protective equipment. Lay Summary: Head and neck surgery is safe for patients during the coronavirus disease 2019 pandemic even when it is lengthy and complex. This is significant because concerns over patient safety raised in many guidelines appear not to be reflected by outcomes, even for those who have other serious illnesses or require complex reconstructions. Patients subjected to suboptimal or nonstandard treatments should be carefully followed up to optimize their cancer outcomes. The overlap between patients and surgeons testing positive for severe acute respiratory syndrome coronavirus 2 is notable and emphasizes the need for fastidious cross-infection controls and effective personal protective equipment.

Aim: This study aimed to describe the change in surgical practice and the impact of SARS-CoV-2 on mortality after surgical resection of colorectal cancer during the initial phases of the SARS-CoV-2 pandemic. Method: This was an international cohort study of patients undergoing elective resection of colon or rectal cancer without preoperative suspicion of SARS-CoV-2. Centres entered data from their first recorded case of COVID-19 until 19 April 2020. The primary outcome was 30-day mortality. Secondary outcomes included anastomotic leak, postoperative SARS-CoV-2 and a comparison with prepandemic European Society of Coloproctology cohort data. Results: From 2073 patients in 40 countries, 1.3% (27/2073) had a defunctioning stoma and 3.0% (63/2073) had an end stoma instead of an anastomosis only. Thirty-day mortality was 1.8% (38/2073), the incidence of postoperative SARS-CoV-2 was 3.8% (78/2073) and the anastomotic leak rate was 4.9% (86/1738). Mortality was lowest in patients without a leak or SARS-CoV-2 (14/1601, 0.9%) and highest in patients with both a leak and SARS-CoV-2 (5/13, 38.5%). Mortality was independently associated with anastomotic leak (adjusted odds ratio 6.01, 95% confidence interval 2.58¿14.06), postoperative SARS-CoV-2 (16.90, 7.86¿36.38), male sex (2.46, 1.01¿5.93), age >70¿years (2.87, 1.32¿6.20) and advanced cancer stage (3.43, 1.16¿10.21). Compared with prepandemic data, there were fewer anastomotic leaks (4.9% versus 7.7%) and an overall shorter length of stay (6 versus 7¿days) but higher mortality (1.7% versus 1.1%). Conclusion: Surgeons need to further mitigate against both SARS-CoV-2 and anastomotic leak when offering surgery during current and future COVID-19 waves based on patient, operative and organizational risks.

Background: In Australia, ethics committees across different states vary in application, requirement and process for the ethical review and approval for clinical research. This may lead to confusion and delays in the enablement of multicentre research projects. This study explores the effect of differing processes for Ethics and Governance in the establishment of the CovidSurg-Cancer study during the global COVID-19 pandemic. Methods: An anonymous, structured web-based questionnaire was designed using the Research Electronic Data Capture application (REDCap) platform to capture consultant surgeons, fellows, and trainees experience in the ethics application process. ¿CovidSurg-Cancer¿ was an international multicentre collaborative study to assess the impact of COVID-19 on the outcomes of patients undergoing cancer surgery. The ethics process to set up this observational study was used as to explore the differing processes applied across Australia. Results: The CovidSurg-Cancer study was successfully set up in 14 hospitals. Four hospitals approved the study directly as an audit. Of the remaining sites, 10 ethics applications underwent Human Research Ethics Committee review following which two (14%) were subsequently approved as an audit activity and eight hospitals (57%) were given formal ethical approval with waiver of consent. Ethics application acceptance from another Australian Human Research Ethics Committee was provided with six applications; however, only three were reciprocated without the requirement for further agreements. A third of (30%) respondents suggested that the details of the application pathway, process and documentation were unclear. Conclusion: Ethics processes are varied across Australia with considerable repetition. A centralized, harmonized application process would enhance collaborative research.

© 2020 BJS Society Ltd Published by John Wiley & Sons Ltd Background: Ileus is common after colorectal surgery and is associated with an increased risk of postoperative complications. Identifying features of normal bowel recovery and the appropriateness for hospital discharge is challenging. This study explored the safety of hospital discharge before the return of bowel function. Methods: A prospective, multicentre cohort study was undertaken across an international collaborative network. Adult patients undergoing elective colorectal resection between January and April 2018 were included. The main outcome of interest was readmission to hospital within 30 days of surgery. The impact of discharge timing according to the return of bowel function was explored using multivariable regression analysis. Other outcomes were postoperative complications within 30 days of surgery, measured using the Clavien¿Dindo classification system. Results: A total of 3288 patients were included in the analysis, of whom 301 (9·2 per cent) were discharged before the return of bowel function. The median duration of hospital stay for patients discharged before and after return of bowel function was 5 (i.q.r. 4¿7) and 7 (6¿8) days respectively (P < 0·001). There were no significant differences in rates of readmission between these groups (6·6 versus 8·0 per cent; P = 0·499), and this remained the case after multivariable adjustment for baseline differences (odds ratio 0·90, 95 per cent c.i. 0·55 to 1·46; P = 0·659). Rates of postoperative complications were also similar in those discharged before versus after return of bowel function (minor: 34·7 versus 39·5 per cent; major 3·3 versus 3·4 per cent; P = 0·110). Conclusion: Discharge before return of bowel function after elective colorectal surgery appears to be safe in appropriately selected patients.

We conducted a systematic review of the literature to establish the prevalence of and predictive factors for parental decision regret in hypospadias surgery. A search strategy without language restrictions was developed with expert help, and two reviewers undertook independent study selection. Five studies were included in this review (four for quantitative analysis) with a total of 783 participants. The mean overall prevalence of parental decision regret was 65.2% (moderate to severe ¿ 20.3%). Although significant predictors of regret were identified (post-operative complications, small size glans, meatal location, decision conflict between parents, parental educational level and others), they had unexplained discordance between studies. Parental decision regret after proximal hypospadias surgery and refusing surgery was inadequately reported. In conclusion, even though the prevalence of parental decision regret after consenting for the hypospadias repair appears to be high, risk factors associated with it were discordant suggesting imprecision in estimates due to unknown confounders.

Background: The National Emergency Laparotomy Audit (NELA) highlights the importance of identifying high-risk patients due to the potential for significant morbidity and mortality. The NELA risk prediction calculator (NRPC) was developed from data in England and Wales and is one of several calculators available. We seek to determine the utility of NRPC in the Australian population and compare it with Portsmouth Physiological and Operative Severity Score for the enumeration of mortality and Morbidity (P-POSSUM) and American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) calculators. Methods: A retrospective review of all emergency laparotomies undertaken at four Australian centers was performed between January 2016 and December 2017. Data extracted from patient records were used to calculate NRPC, ACS-NSQIP, and P-POSSUM scores for 30-day mortality risk. The sensitivity of NRPC was assessed using the NELA high-risk cohort score of =10% and this was compared with the other two calculators. Results: There were 562 (M = 261, mean age = 66 [±17] y) patient charts reviewed in the study period. 59 patients died within 30 d (10.5%). NRPC was able to identify 52 (sensitivity = 88.1%) of these as being within the high-risk group. Using the NELA high-risk cutoff, NRPC identified 52 deaths of 205 (25.4%) high-risk patients, P-POSSUM identified 46 of 245 (18.8%), and ACS-NSQIP identified 46 of 201 (22.9%). Using the McNemar test, no significant difference was noted between NRPC and P-POSSUM (P = 0.07) or NRPC and ACS-NSQIP (P = 0.18). Conclusions: In the Australian context, the NRPC is a highly sensitive and useful tool for predicting 30-day mortality in high-risk emergency laparotomy patients and is comparable with P-POSSUM and ACS-NSQIP calculators.

Background: Anastomotic leak is a common complication after colorectal surgery, associated with increased morbidity and mortality, and poorer long-term survival after oncological resections. Early diagnosis improves short-term outcomes, and may translate into reduced cancer recurrence. Multiple studies have attempted to identify biomarkers to enable earlier diagnosis of anastomotic leak. One study demonstrated that the trajectory of C-reactive protein (CRP) levels was highly predictive of anastomotic leak requiring intervention, with an area under the curve of 0·961. The aim of the present study was to validate this finding externally. Methods: This was a prospective international multicentre observational study of adults undergoing elective colorectal resection with an anastomosis. CRP levels were measured before operation and for 5 days afterwards, or until day of discharge if earlier than this. The primary outcome was anastomotic leak requiring operative or radiological intervention. Results: Between March 2017 and July 2018, 933 patients were recruited from 20 hospitals across Australia, New Zealand, England and Scotland. Some 833 patients had complete CRP data and were included in the primary analysis, of whom 41 (4·9 per cent) developed an anastomotic leak. A change in CRP level exceeding 50 mg/l between any two postoperative days had a sensitivity of 0·85 for detecting a leak, and a high negative predictive value of 0·99 for ruling it out. A change in CRP concentration of more than 50 mg/l between either days 3 and 4 or days 4 and 5 after surgery had a high specificity of 0·96¿0·97, with positive likelihood ratios of 4·99¿6·44 for a leak requiring intervention. Conclusion: This study confirmed the value of CRP trajectory in accurately ruling out an anastomotic leak after colorectal resection.

Background: A direct access colonoscopy service (DACS) for the National Bowel Cancer Screening Program has become standard of care in Newcastle public hospitals because of the effect it has on time to colonoscopy. Cost-effectiveness has not been studied to date. Aim: The aim of this retrospective study was to analyse the cost-effectiveness of a DACS. Methods: Data were collected for patients referred to DACS between January 2014 and June 2016, and patients who were treated on the normal service pathway in 2013 prior to the introduction of the process. A cost-benefit analysis from the patient¿s and local health district¿s perspective was undertaken. Results: Introduction of the DACS produces a direct financial gain to patients in the form of reduced direct costs. It produces an indirect financial gain in terms of increased productivity if the patient is in work, and of increased leisure time if not in work. The DACS is modest income generating for the local health district, an evaluation which is sensitive to internal policies for distribution of government funding within a district. The DACS increases the availability of outpatient consultations to other patients, which is not a quantifiable economic benefit, but is likely to be an overall health benefit. Conclusion: The introduction of DACS in the public system in Australia is of financial benefit to patients and to the local health service provider. It is likely to produce health benefits to non-screening patients, by means of freeing consultations to be used for other indications.

Background: The 2017 National Bowel Cancer Screening Program report records a median time from positive faecal occult blood test to colonoscopy of 53 days. There is some intrinsic delay in accessing specialist medical opinion prior to colonoscopy. Aim: To examine the effect of the introduction of a Direct Access Colonoscopy Service (DACS). Methods: Using prospectively maintained databases, patients undergoing normal service (NS) colonoscopy and those referred to DACS were compared. The primary outcome measure was the time from general practitioner (GP) referral to colonoscopy. Secondary outcome measures included the proportion of patients who met the current recommended 30 days from GP referral to colonoscopy, and the proportion of patients who waited longer than 90 days. Results: There were 289 patients in the NS group, and 601 patients who progressed on the DACS pathway. The demographics of both groups were comparable. DACS patients had a median waiting time of 49 days, significantly shorter than NS patients whose median wait was 79 days (P < 0.0001). Approximately 15.1% patients in the DACS group had their colonoscopy within 30 days from GP referral, significantly better than in the NS group (4.5%, P < 0.001). In the NS group, 41.2% patients waited longer than 90 days from GP referral to colonoscopy, compared with 16.3% in the DACS group (P < 0.001). Conclusion: DACS reduces waiting times to colonoscopy and is associated with an increased proportion of patients undergoing colonoscopy in a timely manner.

Introduction: Previous studies have shown single CRP measurements at time of presentation to have limited predictive benefit for appendicitis. Our objective was to determine the diagnostic utility of serial CRP measurements (to determine CRP velocity [CRPv]) in patients with right iliac fossa (RIF) pain. Methods: A single-centre prospective observational study was conducted on adult patients admitted with RIF pain. CRP was measured on admission, at midnight, and the following morning. Appendicitis was diagnosed on histopathology, or diagnostic imaging in non-operatively managed patients. Therapeutic interventions included all appropriate operative procedures and effective non-operative treatment with antibiotics. Logistic regression was used to generate predictors of therapeutic intervention, and then used to create a new risk score incorporating CRPv. Results: 98 of 112 (87.5%) participants had complete CRP data. 58 patients met the criteria for appendicitis (59.2%). Most patients presented with intermediate Modified Alvarado Scores (MAS) 5¿6 (40.8%) or Appendicitis Inflammatory Response Scores (AIRS) 5¿8 (49%). Our risk score had an AUROC of 0.88 (95% CI 0.81¿0.96) in predicting therapeutic intervention. This score was superior to MAS, AIRS, and single admission biomarker measurements. Patients with an increasing CRPv had 14 times the odds (OR 14.07, 95% CI 0.63¿315.2) of complicated appendicitis, and no cases of complicated appendicitis were observed in patients with a flat CRPv. Conclusions: CRP velocity is superior to single CRP at predicting intervention. Our v-Score shows promise as a decision making-aide by predicting the need for surgical intervention in RIF pain. A flat CRPv identifies a group of patients with a very low risk of complicated appendicitis.

Background: Circulating tumour DNA (ctDNA) has emerged as an excellent candidate for the future of liquid biopsies for many cancers. There has been growing interest in blood-based liquid biopsy because of the potential of ctDNA to produce a noninvasive test that can be used for: the diagnosis of colorectal cancer, monitoring therapy response, and providing information on overall prognosis. The aim of this review was to collate and explore the current evidence regarding ctDNA as a screening tool for colorectal cancer (CRC). Methods: A systematic review of published articles in English over the past 20 y was performed using Medline, Embase, and Cochrane databases on May 23, 2017. After a full-text review, a total of 69 studies were included. Two assessment tools were used to review and compare the methodological quality of these studies. Results: Among the 69 studies included, 17 studies reviewed total cfDNA, whereas six studies looked at the DNA integrity index and 15 focused on ctDNA. There were a total of 40 studies that reviewed methylated cfDNA with 19 of these focussing specifically on SEPT9. Conclusions: The results of this review indicate that methylated epigenetic ctDNA markers are perhaps the most promising candidates for a blood-based CRC-screening modality using cell-free (cf) DNA. Methylated cfDNA appears to be less specific for CRC compared to ctDNA; however, they have demonstrated good sensitivity for early-stage CRC. Further research is required to determine which methylated cfDNA markers are the most accurate when applied to large cohorts of patients. In addition, reliable comparison of results across multiple studies would benefit from standardization of methodology for DNA extraction and PCR techniques in the future.

BACKGROUND: Lower GI hemorrhage is a common source of morbidity and mortality. Tranexamic acid is an antifibrinolytic that has been shown to reduce blood loss in a variety of clinical conditions. Information regarding the use of tranexamic acid in treating lower GI hemorrhage is lacking. OBJECTIVE: The aim of this trial was to determine the clinical efficacy of tranexamic acid when used for lower GI hemorrhage. DESIGN: This was a prospective, double-blind, placebo-controlled, randomized clinical trial. SETTINGS: The study was conducted at a tertiary referral university hospital in Australia. PATIENTS: Consecutive patients aged >18 years with lower GI hemorrhage requiring hospital admission from November 2011 to January 2014 were screened for trial eligibility (N = 265). INTERVENTIONS: A total of 100 patients were recruited after exclusions and were randomly assigned 1:1 to either tranexamic acid or placebo. MAIN OUTCOME MEASURES: The primary outcome was blood loss as determined by reduction in hemoglobin levels. The secondary outcomes were transfusion rates, transfusion volume, intervention rates for bleeding, length of hospital stay, readmission, and complication rates. RESULTS: There was no difference between groups with respect to hemoglobin drop (11 g/L of tranexamic acid vs 13 g/L of placebo; p = 0.9445). There was no difference with respect to transfusion rates (14/49 tranexamic acid vs 16/47 placebo; p = 0.661), mean transfusion volume (1.27 vs 1.93 units; p = 0.355), intervention rates (7/49 vs 13/47; p = 0.134), length of hospital stay (4.67 vs 4.74 d; p = 0.934), readmission, or complication rates. No complications occurred as a direct result of tranexamic acid use. LIMITATIONS: A larger multicenter trial may be required to determine whether there are more subtle advantages with tranexamic acid use in some of the secondary outcomes. CONCLUSIONS: Tranexamic acid does not appear to decrease blood loss or improve clinical outcomes in patients presenting with lower GI hemorrhage in the context of this trial. see Video Abstract at http://links.lww.com/DCR/A453.

Objective: This study aims to report short-term clinical and oncological outcomes from the international transanal Total Mesorectal Excision (taTME) registry for benign and malignant rectal pathology. Background: TaTME is the latest minimally invasive transanal technique pioneered to facilitate difficult pelvic dissections. Outcomes have been published from small cohorts, but larger series can further assess the safety and efficacy of taTME in the wider surgical population. Methods: Data were analyzed from 66 registered units in 23 countries. The primary endpoint was "good-quality TME surgery." Secondary endpoints were short-term adverse events. Univariate and multivariate regression analyses were used to identify independent predictors of poor specimen outcome. Results: A total of 720 consecutively registered cases were analyzed comprising 634 patients with rectal cancer and 86 with benign pathology. Approximately, 67% were males with mean BMI 26.5 kg/m 2. Abdominal or perineal conversion was 6.3% and 2.8%, respectively. Intact TME specimens were achieved in 85%, with minor defects in 11% and major defects in 4%. R1 resection rate was 2.7%. Postoperative mortality and morbidity were 0.5% and 32.6% respectively. Risk factors for poor specimen outcome (suboptimal TME specimen, perforation, and/or R1 resection) on multivariate analysis were positive CRM on staging MRI, low rectal tumor <2 cm from anorectal junction, and laparoscopic transabdominal posterior dissection to <4 cm from anal verge. Conclusions: TaTME appears to be an oncologically safe and effective technique for distal mesorectal dissection with acceptable short-term patient outcomes and good specimen quality. Ongoing structured training and the upcoming randomized controlled trials are needed to assess the technique further.