Management of esophageal anastomotic leaks, a systematic review and network meta-analysis.

There is currently no consensus as to how to manage esophageal anastomotic leaks. Intervention with endoscopic vacuum-assisted closure (EVAC), stenting, reoperation, and conservative management have all been mooted as potential options. To conduct a systematic review and network meta-analysis (NMA) to evaluate the optimal management strategy for esophageal anastomotic leaks. A systematic review was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines with extension for NMA. NMA was performed using R packages and Shiny. In total, 12 retrospective studies were included, which included 511 patients. Of the 449 patients for whom data regarding sex was available, 371 (82.6%) were male, 78 (17.4%) were female. The average age of patients was 62.6 years (standard deviation 10.2). The stenting cohort included 245 (47.9%) patients. The EVAC cohort included 123 (24.1%) patients. The conservative cohort included 87 (17.0%) patients. The reoperation cohort included 56 (10.9%) patients. EVAC had a significantly decreased complication rate compared to stenting (odds ratio 0.23 95%, confidence interval [CI] 0.09;0.58). EVAC had a significantly lower mortality rate than stenting (odds ratio 0.43, 95% CI 0.21; 0.87). Reoperation was used in significantly larger leaks than stenting (mean difference 14.66, 95% CI 4.61;24.70). The growing use of EVAC as a first-line intervention in esophageal anastomotic leaks should continue given its proven effectiveness and significant reduction in both complication and mortality rates. Surgical management is often necessary for significantly larger leaks and will likely remain an effective option in uncontained leaks with systemic features.

Methodology for Robotic In Vitro Testing of the Knee.

The knee joint plays a pivotal role in mobility and stability during ambulatory and standing activities of daily living (ADL). Increased incidence of knee joint pathologies and resulting surgeries has led to a growing need to understand the kinematics and kinetics of the knee. In vivo, in silico, and in vitro testing domains provide researchers different avenues to explore the effects of surgical interactions on the knee. Recent hardware and software advancements have increased the flexibility of in vitro testing, opening further opportunities to answer clinical questions. This paper describes best practices for conducting in vitro knee biomechanical testing by providing guidelines for future research. Prior to beginning an in vitro knee study, the clinical question must be identified by the research and clinical teams to determine if in vitro testing is necessary to answer the question and serve as the gold standard for problem resolution. After determining the clinical question, a series of questions (What surgical or experimental conditions should be varied to answer the clinical question, what measurements are needed for each surgical or experimental condition, what loading conditions will generate the desired measurements, and do the loading conditions require muscle actuation?) must be discussed to help dictate the type of hardware and software necessary to adequately answer the clinical question. Hardware (type of robot, load cell, actuators, fixtures, motion capture, ancillary sensors) and software (type of coordinate systems used for kinematics and kinetics, type of control) can then be acquired to create a testing system tailored to the desired testing conditions. Study design and verification steps should be decided upon prior to testing to maintain the accuracy of the collected data. Collected data should be reported with any supplementary metrics (RMS error, dynamic statistics) that help illuminate the reported results. An example study comparing two different anterior cruciate ligament reconstruction techniques is provided to demonstrate the application of these guidelines. Adoption of these guidelines may allow for better interlaboratory result comparison to improve clinical outcomes.

An ergonomic study of arborist work activities.

Arborists work in high-risk environments, particularly when climbing trees, where a combination of grip strength and resistance to psychological stress are important attributes for safety. This study investigated the physical and cognitive activities of arborists combined with selected workload factors such as blood pressure, pulse, handgrip strength, and other anthropometric measurements, including manual dexterity and spatial awareness. The sample included 10 participants aged 17-48 years. Blood pressure was negatively correlated with handgrip strength after the activity had been performed. Different types of arborist activities led to various types of physiological feedback, as shown by the analysis of variance. According to our results, there is a difference between physical workloads, associated with activities such as tree felling, tree climbing, or chainsaw maintenance, and cognitive workloads, such as supervision or observation, in relation to blood pressure. Blood pressure was higher for activities that involved a cognitive workload. Before and after any activity, handgrip strength was positively associated with hand size. After any activity, greater changes in handgrip strength of the participant's right hand were associated with needing more time to successfully complete a peg test, which represents a greater cognitive burden. Our results suggest that arborists deal with physical activities such as tree felling, tree climbing, working with a chainsaw, and mental activities (supervising or observing) which were identified as two different groups correlated with hand grip strength, blood pressure, manual dexterity, and spatial awareness. In conclusion, the tree-climbing activity appeared to be the least stressful, and psychological stress appeared to have a greater impact on the health of observers and supervisors in the study group. This can be applied to other professions in many fields, including industries where workers face both physical and cognitive workloads.

Evaluating analgesia strategies in patients who have undergone oesophagectomy-a systematic review and network meta-analysis of randomised clinical trials.

Optimal pain control following esophagectomy remains a topic of contention. The aim was to perform a systematic review and network meta-analysis (NMA) of randomized clinical trials (RCTs) evaluating the analgesia strategies post-esophagectomy. A NMA was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-NMA guidelines. Statistical analysis was performed using Shiny and R. Fourteen RCTs which included 565 patients and assessed nine analgesia techniques were included. Relative to systemic opioids, thoracic epidural analgesia (TEA) significantly reduced static pain scores at 24 hours post-operatively (mean difference (MD): -13.73, 95% Confidence Interval (CI): -27.01-0.45) (n = 424, 12 RCTs). Intrapleural analgesia (IPA) demonstrated the best efficacy for static (MD: -36.2, 95% CI: -61.44-10.96) (n = 569, 15 RCTs) and dynamic (MD: -42.90, 95% CI: -68.42-17.38) (n = 444, 11 RCTs) pain scores at 48 hours. TEA also significantly reduced static (MD: -13.05, 95% CI: -22.74-3.36) and dynamic (MD: -18.08, 95% CI: -31.70-4.40) pain scores at 48 hours post-operatively, as well as reducing opioid consumption at 24 hours (MD: -33.20, 95% CI: -60.57-5.83) and 48 hours (MD: -42.66, 95% CI: -59.45-25.88). Moreover, TEA significantly shortened intensive care unit (ICU) stays (MD: -5.00, 95% CI: -6.82-3.18) and time to extubation (MD: -4.40, 95% CI: -5.91-2.89) while increased post-operative forced vital capacity (MD: 9.89, 95% CI: 0.91-18.87) and forced expiratory volume (MD: 13.87, 95% CI: 0.87-26.87). TEA provides optimal pain control and improved post-operative respiratory function in patients post-esophagectomy, reducing ICU stays, one of the benchmarks of improved post-operative recovery. IPA demonstrates promising results for potential implementation in the future following esophagectomy.

Evaluating mesh fixation techniques for ventral hernia repair: A systematic review and network meta-analysis of randomised control trials.

INTRODUCTION: There is uncertainty regarding the optimal mesh fixation techniques for laparoscopic ventral and incisional hernia repair. AIM: To perform a systematic review and network meta-analysis of randomised control trials (RCTs) to investigate the advantages and disadvantages associated with absorbable tacks, non-absorbable tacks, non-absorbable sutures, non-absorbable staples, absorbable synthetic glue, absorbable sutures and non-absorbable tacks, and non-absorbable sutures and non-absorbable tacks. METHODS: A systematic review was performed as per PRISMA-NMA guidelines. Odds ratios (ORs) and mean differences (MDs) were extracted to compare the efficacy of the surgical approaches. RESULTS: Nine RCTs were included with 707 patients. Short-term pain was significantly reduced in non-absorbable staples (MD; -1.56, confidence interval (CI); -2.93 to -0.19) and non-absorbable sutures (MD; -1.00, CI; -1.60 to -0.40) relative to absorbable tacks. Recurrence, length of stay, operative time, conversion to open surgery, seroma and haematoma formation were unaffected by mesh fixation technique. CONCLUSION: Short-term post-operative pain maybe reduced by the use of non-absorbable sutures and non-absorbable staples. There is clinical equipoise between each modality in relation to recurrence, length of stay, and operative time.

Minimally Invasive and Open Gastrectomy for Gastric Cancer: A Systematic Review and Network Meta-Analysis of Randomized Clinical Trials.

BACKGROUND AND OBJECTIVES: Optimal surgical management for gastric cancer remains controversial. We aimed to perform a network meta-analysis (NMA) of randomized clinical trials (RCTs) comparing outcomes after open gastrectomy (OG), laparoscopic-assisted gastrectomy (LAG), and robotic gastrectomy (RG) for gastric cancer. METHODS: A systematic search of electronic databases was undertaken. An NMA was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-NMA guidelines. Statistical analysis was performed using R and Shiny. RESULTS: Twenty-two RCTs including 6890 patients were included. Overall, 49.6% of patients underwent LAG (3420/6890), 46.6% underwent OG (3212/6890), and 3.7% underwent RG (258/6890). At NMA, there was a no significant difference in recurrence rates following LAG (odds ratio [OR] 1.09, 95% confidence interval [CI] 0.77-1.49) compared with OG. Similarly, overall survival (OS) outcomes were identical following OG and LAG (OS: OG, 87.0% [1652/1898] vs. LAG: OG, 87.0% [1650/1896]), with no differences in OS in meta-analysis (OR 1.02, 95% CI 0.77-1.52). Importantly, patients undergoing LAG experienced reduced intraoperative blood loss, surgical incisions, distance from proximal margins, postoperative hospital stays, and morbidity post-resection. CONCLUSIONS: LAG was associated with non-inferior oncological and surgical outcomes compared with OG. Surgical outcomes following LAG and RG superseded OG, with similar outcomes observed for both LAG and RG. Given these findings, minimally invasive approaches should be considered for the resection of local gastric cancer, once surgeon and institutional expertise allows.

Successful maintenance of process and outcomes for oesophageal cancer surgery in Ireland during the first wave of the COVID-19 pandemic.

INTRODUCTION: The emergence of the novel coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the coronavirus disease COVID-19 has impacted enormously on non-COVID-19-related hospital care. Curtailment of intensive care unit (ICU) access threatens complex surgery, particularly impacting on outcomes for time-sensitive cancer surgery. Oesophageal cancer surgery is a good example. This study explored the impact of the pandemic on process and short-term surgical outcomes, comparing the first wave of the pandemic from April to June in 2020 with the same period in 2019. METHODS: Data from all four Irish oesophageal cancer centres were reviewed. All patients undergoing resection for oesophageal malignancy from 1 April to 30 June inclusive in 2020 and 2019 were included. Patient, disease, and peri-operative outcomes (including COVID-19 infection) were compared. RESULTS: In 2020, 45 patients underwent oesophagectomy, and 53 in the equivalent period in 2019. There were no differences in patient demographics, co-morbidities, or use of neoadjuvant therapy. The median time to surgery from neoadjuvant therapy was 8 weeks in both 2020 and 2019. There were no significant differences in operative interventions between the two time periods. There was no difference in operative morbidity in 2020 and 2019 (28% vs 40%, p = 0.28). There was no in-hospital mortality in either period. No patient contracted COVID-19 in the perioperative period. CONCLUSIONS: Continuing surgical resection for oesophageal cancer was feasible and safe during the COVID-19 pandemic in Ireland. The national response to this threat was therefore successful by these criteria in the curative management of oesophageal cancer.

The PROMISⓇ-Plus-Osteoarthritis of the Knee (OAK) profile measure integrates generic and condition-specific content to enhance relevance and efficiency.

OBJECTIVE: The Patient-Reported Outcomes Measurement Information System (PROMIS)-Plus-Osteoarthritis of the Knee (OAK) profile integrates universal PROMIS items with knee-specific items across 13 domains. We evaluated the psychometric properties of a subset of six domains associated with quality of life in people with OAK. STUDY DESIGN AND SETTING: In a cross-sectional study of OAK patients (n=600), we estimated reliability using Pearson and Spearman correlations with Knee Injury and Osteoarthritis Outcome Score (KOOS) subscores and known-groups validity with PROMIS Global Health. Measure responsiveness was tested via paired t-tests in a longitudinal study (n=238), pre/post total knee replacement. RESULTS: Across the six domains, internal consistency reliability (Cronbach's alpha) was 0.77-0.95 and test-retest reliability (intraclass correlation coefficients) was ≥0.90. Correlations with Knee Injury and Osteoarthritis Outcome Score (KOOS) subscores and PROMIS Global supported convergent and divergent validity. Known-groups validity testing revealed better scores in all domains for high vs. low global status groups, and knee-specific items added value in physical function and pain. All domains reflected (p<0.001) better health status scores at follow up. CONCLUSION: The six PROMIS-Plus-OAK profile domains demonstrated good psychometric characteristics. The measure integrates universal and knee-specific content to provide enhanced relevance, measurement precision and efficient administration for patient care and clinical research.

Surgery by a minimally invasive approach is associated with improved textbook outcomes in oesophageal and gastric cancer.

INTRODUCTION: Textbook outcome (TBO) is a composite measure of a number of peri-operative and clinical outcomes in oesophagogastric malignancy. It has previously been shown that TBOs are associated with improved overall survival in both oesophageal and gastric cancer. The influence of a minimally invasive approach (MIA) on TBO is not well defined. The purpose of this study is to validate TBO in our population, examine the influence of a MIA on achieving a TBO, and the impact of TBO on long-term survival. METHODS: 269 patients undergoing oesophagectomy and 258 patients undergoing subtotal or total gastrectomy were included in this study. Demographic, clinical and pathological differences between patients with and without a TBO were compared using univariable and multivariable analysis. Overall survival for those with and without a TBO was examined. The influence of MIA on overall survival and TBO was determined using Cox proportional hazard models. RESULTS: Patients undergoing oesophagectomy and gastrectomy were significantly more likely to achieve a TBO when MIA was used (p = 0.01 and 0.001 respectively). When MIA is included as an outcome measure patients achieving a TBO show improved overall survival in both oesophageal and gastric cancer. MIA, clear resection margins and no unplanned admission to critical care are the strongest predictors of overall survival from the putative bundle of TBO parameters. CONCLUSION: Minimally invasive surgery is associated with improved TBO. Completion of a minimally invasive approach should be considered for inclusion as a textbook parameter.

Impact of the COVID-19 pandemic on management and outcomes in acute appendicitis: Should these new practices be the norm?

BACKGROUND: In early 2020, the COVID-19 pandemic significantly altered management of surgical patients globally. International guidelines recommended that non-operative management be implemented wherever possible (e.g. in proven uncomplicated appendicitis) to reduce pressure on healthcare services and reduce risk of peri-operative viral transmission. We sought to compare our management and outcomes of appendicitis during lockdown vs a non-pandemic period. METHODS: All presentations to our department with a clinical diagnosis of acute appendicitis between 12/03/2020 and 30/06/2020 were compared to the same 110-day period in 2019. Quantity and severity of presentations, use of radiological investigations, rate of operative intervention and histopathological findings were variables collected for comparison. RESULTS: There was a reduction in appendicitis presentations (from 74 to 56 cases), and an increase in radiological imaging (from 70.27% to 89.29%) (P = 0.007) from 2019 to 2020. In 2019, 93.24% of patients had appendicectomy, compared to 71.42% in 2020(P < 0.001). This decrease was most pronounced in uncomplicated cases, whose operative rates dropped from 90.32% to 62.5% (P = 0.009). Post-operative histology confirmed appendicitis in 73.9% in 2019, compared to 97.5% in 2020 (P = 0.001). Normal appendiceal pathology was reported for 17 cases (24.64%) in 2019, compared to none in 2020 (P < 0.001) - a 0% negative appendicectomy rate (NAR). DISCUSSION: The 0% NAR in 2020 is due to a combination of increased CT imaging, a higher threshold to operate, and is impacted by increased disease severity due to delayed patient presentation. This study adds to growing literature promoting routine use of radiological imaging to confirm appendicitis diagnosis. As we enter a second lockdown, patients should be encouraged to avoid late presentations, and surgical departments should continue using radiological imaging more liberally in guiding appendicitis management.

Options in Bariatric Surgery: Modeled Decision Analysis Supports One-Anastomosis Gastric Bypass as the Treatment of Choice when Type 2 Diabetes Is Present.

BACKGROUND: Obesity and type 2 diabetes mellitus (T2DM) represent significant healthcare burdens. Surgical management is superior to traditional medical therapy. Laparoscopic sleeve gastrectomy (LSG) and gastric bypass (both Roux-en-Y (RYGB) and one anastomosis gastric bypass (OAGB) are the most commonly performed metabolic procedures. It remains unclear which gives the optimal quality-of-life pay-off in the context of T2DM. This study compares LSG, RYGB, and OAGB in the management of T2DM and obesity using modeled decision analysis. Alternative approaches were assessed considering efficacy of interventions, post-operative complications, and quality of life outcomes to determine the optimal approach. METHODS: Modeled decision analysis was performed from the patent's perspective comparing best medical management (MM), SG, RYGB, OAGB, and LAGB. The base case is a 40-year-old female with a body mass index (BMI) of 40 and T2DM. Input variables were calculated based on published decision analyses and a literature review. Utilities were based on previous studies. Sensitivity analysis was performed. The payoff was quality-adjusted life years (QALYs) 5 years from intervention. TreeAge Pro modeling software was used for analysis. RESULTS: In 5-years post-procedure, OAGB gave the optimal QALY payoff of 3.65 QALYs (reviewer 2). RYGB gave 3.47, SG gave 3.08, LAGB gave 2.62 and MM 2.45 QALYs. Three input variables proved sensitive. RYGB is optimal if its metabolic improvement rates exceed 86%. It is also optimal if metabolic improvement rates in OAGB drop below 71.8% or if the utility of OAGB drops below 0.759. CONCLUSION: OAGB gives the optimal QALY payoff in treatment of T2DM. RYGB and SG also improve metabolic outcomes and remain viable options in selected patients.

The effect of a pre- and post-operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial): Study protocol for a randomised controlled trial.

BACKGROUND: Advances in peri-operative oncological treatment, surgery and peri-operative care have improved survival for patients with oesophagogastric cancers. Neoadjuvant cancer treatment (NCT) reduces physical fitness, which may reduce both compliance and tolerance of NCT as well as compromising post-operative outcomes. This is particularly detrimental in a patient group where malnutrition is common and surgery is demanding. The aim of this trial is to assess the effect on physical fitness and clinical outcomes of a comprehensive exercise training programme in patients undergoing NCT and surgical resection for oesophagogastric malignancies. METHODS: The PERIOP-OG trial is a pragmatic, multi-centre, randomised controlled trial comparing a peri-operative exercise programme with standard care in patients with oesophagogastric cancers treated with NCT and surgery. The intervention group undergo a formal exercise training programme and the usual care group receive standard clinical care (no formal exercise advice). The training programme is initiated at cancer diagnosis, continued during NCT, between NCT and surgery, and resumes after surgery. All participants undergo assessments at baseline, post-NCT, pre-surgery and at 4 and 10 weeks after surgery. The primary endpoint is cardiorespiratory fitness measured by demonstration of a 15% difference in the 6-min walk test assessed at the pre-surgery timepoint. Secondary endpoints include measures of physical health (upper and lower body strength tests), body mass index, frailty, activity behaviour, psychological and health-related quality of life outcomes. Exploratory endpoints include a health economics analysis, assessment of clinical health by post-operative morbidity scores, hospital length of stay, nutritional status, immune and inflammatory markers, and response to NCT. Rates of NCT toxicity, tolerance and compliance will also be assessed. DISCUSSION: The PERIOP-OG trial will determine whether, when compared to usual care, exercise training initiated at diagnosis and continued during NCT, between NCT and surgery and then during recovery, can maintain or improve cardiorespiratory fitness and other physical, psychological and clinical health outcomes. This trial will inform both the prescription of exercise regimes as well as the design of a larger prehabilitation and rehabilitation trial to investigate whether exercise in combination with nutritional and psychological interventions elicit greater benefits. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03807518 . Registered on 1 January 2019.

Barrett's Registry Collaboration of academic centers in Ireland reveals high progression rate of low-grade dysplasia and low risk from nondysplastic Barrett's esophagus: report of the RIBBON network.

Barrett's esophagus (BE) is the main pathological precursor of esophageal adenocarcinoma (EAC). Progression to high-grade dysplasia (HGD) or EAC from nondysplastic BE (NDBE), low-grade dysplasia (LGD) and indefinite for dysplasia (IND) varies widely between population-based studies and specialized centers for many reasons, principally the rigor of the biopsy protocol and the accuracy of pathologic definition. In the Republic of Ireland, a multicenter prospective registry and bioresource (RIBBON) was established in 2011 involving six academic medical centers, and this paper represents the first report from this network. A detailed clinical, endoscopic and pathologic database registered 3,557 patients. BE was defined strictly by both endoscopic evidence of Barrett's epithelium and the presence of specialized intestinal metaplasia (SIM). A prospective web-based database was used to gather information with initial and follow-up data abstracted by a data manager at each site. A total of 2,244 patients, 1,925 with no dysplasia, were included with complete follow-up. The median age at diagnosis was 60.5 with a 2.1:1 male to female ratio and a median follow-up time of 2.7 years (IQR 1.19-4.04), and 6609.25 person years. In this time period, 125 (5.57%) progressed to HGD/EAC, with 74 (3.3%) after 1 year of follow-up and 38 (1.69%) developed EAC, with 20 (0.89%) beyond 1 year. The overall incidence of HGD/EAC was 1.89% per year; 1.16% if the first year is excluded. The risk of progression to EAC alone overall was 0.57% per year, 0.31% excluding the first year, and 0.21% in the 1,925 patients who had SIM alone at diagnosis. Low-grade dysplasia (LGD) progressed to HGD/EAC in 31% of patients, a progression rate of 12.96% per year, 6.71% with the first year excluded. In a national collaboration of academic centers in Ireland, the progression rate for NDBE was similar to recent population studies. Almost one in two who progressed was evident within 1 year. Crucially, LGD diagnosed and confirmed by specialist gastrointestinal pathologists represents truly high-risk disease, highlighting the importance of expertise in diagnosis and management, and providing indirect support for ablative therapies in this context.

Perioperative prehabilitation and rehabilitation in esophagogastric malignancies: a systematic review.

Cancers of the esophagus and stomach are challenging to treat. With the advent of neoadjuvant therapies, patients frequently have a preoperative window with potential to optimize their status before major resectional surgery. It is unclear as to whether a prehabilitation or optimization program can affect surgical outcomes. This systematic review appraises the current evidence for prehabilitation and rehabilitation in esophagogastric malignancy. A literature search was performed according to PRISMA guidelines using PubMed, EMBASE, Cochrane Library, Google Scholar, and Scopus. Studies including patients undergoing esophagectomy or gastrectomy were included. Studies reporting on at least one of aerobic capacity, muscle strength, quality of life, morbidity, and mortality were included. Twelve studies were identified for inclusion, comprising a total of 937 patients. There was significant heterogeneity between studies, with a variety of interventions, timelines, and outcome measures reported. Inspiratory muscle training (IMT) consistently showed improvements in functional status preoperatively, with three studies showing improvements in respiratory complications with IMT. Postoperative rehabilitation was associated with improved clinical outcomes. There may be a role for prehabilitation among patients undergoing major resectional surgery in esophagogastric malignancy. A large randomized controlled trial is warranted to investigate this further.

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

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

Options in bariatric surgery: modeled decision analysis supports Roux-en-Y gastric bypass and sleeve gastrectomy as the treatments of choice.

BACKGROUND: Obesity is a chronic disease associated with significant morbidity and mortality. Bariatric surgery has been shown to significantly reduce both morbidity and mortality. Numerous surgical strategies exist, but the most frequently used worldwide are adjustable gastric banding, sleeve gastrectomy (SG), and Roux-en-Y gastric bypass (RYGB). It is not clear which of these strategies provides the optimal quality-of-life pay-off. OBJECTIVE: Modeled decision analysis allows comparison of different treatment interventions allowing for plausible differences in input variables. This facilitates establishment of the optimal intervention under numerous conditions. SETTING: University Hospital, Ireland. METHODS: Modeled decision analysis was performed from the patient's perspective comparing best medical therapy, adjustable gastric banding, SG, and RYGB. Input variables were calculated based on previously published decision analyses and a systematic search of obesity-related literature. Utilities were based on previously published studies. One-way sensitivity analysis was performed. Sensitive variables underwent 3-way analysis. RESULTS: The optimal treatment strategy in the base case was RYGB with a quality-adjusted life-year payoff (QALY) of 1.53 QALYs at 2 years postprocedure. Sleeve gastrectomy provided 1.49 QALYs. Medical therapy and adjustable gastric banding provided .98 and .96 QALYs, respectively. Rate of complications in RYGB and the utility of SG and RYGB proved sensitive. If complication rates are high, SG becomes the optimal strategy. Sensitive thresholds were established for the utility of SG and RYGB at .804 and .78, respectively. CONCLUSION: SG and RYGB offer similar outcomes in terms of QALY payoffs. Decision making should be in line with institutional and patient preference.

A study evaluating cost awareness amongst surgeons in a health service under financial strain.

BACKGROUND: Despite having considerable influence over resource allocation clinicians possess poor knowledge of healthcare costs. This study evaluated surgeons' cost-awareness with regard to surgical equipment and assessed attitudes towards health economics training using survey format. MATERIALS AND METHODS: An online survey was distributed to 326 surgeons across a range of specialties in Ireland. Respondents were asked about their surgical expertise, previous training in health economics, and its role in the surgical curriculum. They were also asked to estimate the recommended retail price (RRP) of 17 commonly used items of surgical equipment. Answers within ±25% of the RRP were considered correct. RESULTS: Of 140 respondents, 62 (44.3%) were on a surgical training scheme and 16 (11.4%) were consultants. Overall, surgeons correctly estimated the RRP of only 14.0% of items. There was no difference in accuracy between surgeons in later years of training compared to their junior counterparts (13.1 ±â€¯8.8% versus 15.0 ±â€¯8.8%, p = 0.115). The highest individual score was six out of 17 items correctly estimated. Participants overestimated the cost of low-cost items by 347.7% and underestimated the cost of high-cost items by 35.5%. Only 5.7% of participants had received undergraduate training in health economics but 75.0% felt it should be included in the curriculum. Over two-thirds said their practice would change if they had better knowledge of the cost of surgical equipment. CONCLUSION: The majority of surgeons receive little training in health economics and have poor knowledge of the cost of surgical equipment. Most would welcome more training at both an undergraduate and postgraduate level. An opportunity exists to promote cost awareness in the operating room, which could lead to a reduction in waste and improved use of resources.

Meta-Analysis of Enhanced Recovery Protocols in Bariatric Surgery.

BACKGROUND: Enhanced recovery after surgery (ERAS) guidelines, fast-track protocols, and alternative clinical pathways have been widely promoted in a variety of disciplines leading to improved outcomes in post-operative morbidity and length of stay (LOS). This meta-analysis assesses the implications of standardized management protocols in bariatric surgery. METHODS: The PRISMA guidelines were adhered to. Databases were searched with the application of pre-defined inclusion and exclusion criteria. Results were reported as mean differences or pooled odds ratios (OR) with 95% confidence intervals (95% CI). Individual protocols and surgical approaches were assessed through subgroup analysis, and sensitivity analysis of methodological quality was performed. RESULTS: A total of 1536 studies were screened; 13 studies were eventually included for meta-analysis involving a total of 6172 patients. Standardized perioperative techniques were associated with a savings of 19.5 min in operative time (p < 0.01), as well as a LOS which was shortened by 1.5 days (p < 0.01). Pooled post-operative morbidity rates also favored enhanced recovery care protocols (OR 0.7%, 95% CI 0.6-0.9%, p < 0.01). CONCLUSION: Bariatric surgery involves a complex cohort of patients who require high-quality evidence-based care to improve outcomes. Consensus guidelines on the feasibility of ERAS and alternative clinical pathways are required in the setting of bariatric surgery.

Meta-analysis of outcomes of endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for the management of acute cholecystitis.

BACKGROUND: Endoscopic ultrasound-guided gallbladder drainage is a novel method of treating acute cholecystitis in patients deemed too high risk for surgery. It involves endoscopic stent placement between the gallbladder and the alimentary tract to internally drain the infection and is an alternative to percutaneous cholecystostomy (PC). This meta-analysis assesses the clinical outcomes of high-risk patients undergoing endoscopic drainage with an acute cholecystoenterostomy (ACE) compared with PC in acute cholecystitis. METHODS: A literature search was performed using the preferred reporting items for systematic reviews and meta-analyses guidelines. Databases were searched for studies reporting outcomes of patients undergoing ACE or PC. Results were reported as mean differences or pooled odds ratios (OR) with 95% confidence intervals (95% CI). RESULTS: A total of 1593 citations were reviewed; five studies comprising 495 patients were ultimately selected for analysis. There were no differences in technical or clinical success rates between the two groups on pooled meta-analysis. ACE had significantly lower post-procedural pain scores (mean difference - 3.0, 95% CI - 2.3 to - 3.6, p < 0.001, on a 10-point pain scale). There were no statistically significant differences in procedure complications between groups. Re-intervention rates were significantly higher in the PC group (OR 4.3, 95% CI 2.0-9.3, p < 0.001). CONCLUSION: ACE is a promising alternative to PC in high-risk patients with acute cholecystitis, with equivalent success rates, improved pain scores and lower re-intervention rates, without the morbidities associated with external drainage.

A Randomized Controlled Trial on the Effect of a Double Check on the Detection of Medication Errors.

STUDY OBJECTIVE: The use of a double check by 2 nurses has been advocated as a key error-prevention strategy. This study aims to determine how often a double check is used for high-alert medications and whether it increases error detection. METHODS: Emergency department and ICU nurses worked in pairs to care for a simulated patient. Nurses were randomized into single- and double-check groups. Errors intentionally introduced into the simulation included weight-based dosage errors and wrong medication vial errors. The evaluator recorded whether a double check was used, whether errors were detected, and observational data about nurse behavior during the simulation. RESULTS: Forty-three pairs of nurses consented to enroll in the study. All nurses randomized to the double-check group used a double check. In the single-check group, 9% of nurses detected the weight-based dosage error compared with 33% of nurses in the double-check group (odds ratio 5.0; 95% confidence interval 0.90 to 27.74). Fifty-four percent of nurses in the single-check group detected the wrong vial error compared with 100% of nurses in the double-check group (odds ratio 19.9; 95% confidence interval 1.0 to 408.5). CONCLUSION: Our study demonstrates that nurses use double checks before administering high-alert medications. Use of a double check increases certain error detection rates in some circumstances, but not others. Both techniques missed many errors. In some cases, the second nurse actually dissuaded the first nurse from acting on the error.