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Peter A Walker,1 Shinil K Shah,1,2 Erik B Wilson11Department of Surgery, University of Texas Medical School at Houston, Houston, TX, USA; 2Michael E DeBakey Institute for Comparative Cardiovascular Science and Biomedical Devices, Texas A&M University, College Station, TX, USAIntroduction: Novel trocar closure devices using subperitoneal anchor placement avoid the need for a closed loop suture, and could allow faster trocar site closure with less risk derived from less instrument penetration into the abdominal cavity while decreasing fascial ischemia and tension. We completed a series of animal experiments to compare the Carter-Thomason® suture closure device and neoClose® AnchorGuide device in order to evaluate device safety, efficacy, and ease of utilization.Methods: A porcine model was utilized where 12 mm port sites were closed with either the Carter-Thomason® device or neoClose® AnchorGuide device. Animals were sacrificed at 14 and 56 days after trocar site closure followed by macroscopic and microscopic wound examination. A second group of animals underwent video analysis to evaluate the time required for fascial closure as well as depth of needle passage into the abdomen.Results: All animals survived to the endpoints (14 and 56 days) without mortality or trocar site hernia. A trend towards decreased closure times was identified when using the neoClose® device (t=18.5±2.3 seconds) compared to closure with the Carter-Thomason® device (t=32.0±8.9 seconds) (P=0.153). A significant decrease in the depth of needle penetration was seen with the neoClose® device (t=31.22±1.45 mm) compared to closure with the Carter-Thomason device (t=51.0±3.1 mm) (P

Abstract The socioeconomic factors driving the adoption of birth limitation and lengthening birth intervals as fertility control mechanisms in sub-Saharan Africa are a subject of debate. There are also arguments over what accounts for the low performance of the adopted fertility control mechanisms, and the break experienced in the fertility transition process. To fill the gaps, the authors work from a life-course perspective and linked data from the National Bureau of Statistics and the National Population Commission to collect retrospective data from 416 participants. Drawing on the socioeconomic framework, the roles of unemployment and grandparental support in reproductive decisions were tested. Results suggest that the unemployment situation is an underlying mechanism that triggered the adoption of birth control measures in Nigeria. The results also suggest that grandparental support accounts for the slow pace of the fertility transition process. This current study concludes that the unemployment situation pressures parents to reduce the number of childbirth. However, where grandparental support for grandchildren is available, parents tend to have a large family size in line with the pro-natalist nature of Nigerians.

Over time, Nigeria has experienced upsurge in external debt stock and several studies have estimated negative impact of growing external debt on economic growth. On sectoral basis therefore, our study proceeds to evaluate such impact of external debt on growth of agricultural production in Nigeria using time series data from 1980 to 2017. For this purpose, we utilized co-integration being test instrument and ECM to investigate link among variables used. The empirical results reveal that external debt failed to yield increase in output returns in agricultural productivity by its inverse association with agricultural output. This indicates that acquired external loans for agriculture within period of study were not optimally utilized for same resolve. Hence, we advise that Nigerian government should demonstrate sound commitment to effective debt management in order to ensure foreign loans are suitably channeled and healthily utilized for purpose acquired for as this would equally guarantee that the output returns would be sufficient for debt service obligation and balance to promote growth in other sectors of Nigerian economy.

Objetivo: Establecer la prevalencia de la patología maligna en pacientes con masa sólida palpable, sin diagnóstico previo de cáncer de seno en dos hospitales de Bogotá, Colombia. Materiales y métodos: Estudio descriptivo retrospectivo entre marzo de 2010 y febrero de 2013 en los hospitales de San José e Infantil Universitario de San José, Bogotá D. C., Colombia. Se incluyeron mujeres mayores de 14 años que consultaron por masa sólida palpable sin diagnóstico previo de cáncer de seno, corroborada por examen físico; no se consideró ningún criterio de exclusión. Los datos se recolectaron de las historias clínicas y se llevaron a un formato creado por los investigadores. El programa estadístico utilizado fue Stata 13. Resultados: Se confirmó la masa en 342 pacientes por examen clínico, en 307 pacientes con resultado de biopsia. La prevalencia de la patología maligna fue 12,2% y benigna 71,66%. Discusión: La prevalencia de patología maligna por masa palpable fue menor que los datos reportados a nivel mundial, siendo el tumor más frecuente el carcinoma ductal infiltrante en un 87%, carcinoma lobulillar infiltrante en 6,4%), con estadio clínico IIA y BI-RADS 4 A (ecografía) y BI-RADS 4 B (mamografía).

Abstract Background A key feature of a good general practice consultation is that it is patient-centred. A number of verbal and non-verbal behaviours have been identified as important to establish a good relationship with the patient. However, the use of the computer detracts the doctor's attention away from the patient, compromising these essential elements of the consultation. Current methods to assess the consultation and the influence of the computer on them are time consuming and subjective. If it were possible to measure these quantitatively, it could provide the basis for the first truly objective way of studying the influence of the computer on the consultation. The aim was to assess whether pattern recognition software could be used to measure the influence and pattern of computer use in the consultation. If this proved possible it would provide, for the first time, an objective quantitative measure of computer use and a measure of the attention and responsiveness of the general practitioner towards the patient. Methods A feasibility study using pattern recognition software to analyse a consultation was conducted. A web camera, linked to a data-gathering node was used to film a simulated consultation in a standard office. Members of the research team enacted the role of the doctor and the patient, using pattern recognition software to try and capture patient-centred, non-verbal behaviour. As this was a feasibility study detailed results of the analysis are not presented. Results It was revealed that pattern recognition software could be used to analyse certain aspects of a simulated consultation. For example, trigger lines enabled the number of times the clinician's hand covered the keyboard to be counted and wrapping recorded the number of times the clinician nodded his head. It was also possible to measure time sequences and whether the movement was brief or lingering. Conclusion Pattern recognition software enables movements associated with patient-centredness to be recorded. Pattern recognition software has the potential to provide an objective, quantitative measure of the influence of the computer on the consultation.

Purpose: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive day procedure that the MERIT randomized controlled trial (RCT) has demonstrated to be an effective and safe method of weight loss versus lifestyle modification alone. We sought to evaluate the cost-effectiveness of ESG from the perspective of a US commercial payer in a cohort of adults with class II and class I obesity with diabetes based on this RCT., Materials: We used a Markov modelling approach with BMI group health states and an absorbing death state. Baseline characteristics, utilities, BMI group transition probabilities, and adverse events (AEs) were informed by patient-level data from the MERIT RCT. Mortality was estimated by applying BMI-specific hazard ratios to US general population mortality rates. We used BMI-based health state utilities to reflect the impact of obesity comorbidities and applied disutilities due to ESG AEs. Costs included intervention costs, AE costs, and BMI-based annual direct healthcare costs to account for costs associated with obesity comorbidities. A willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY) was assumed., Results: In our base-case analysis over a 5-year time horizon, ESG was cost-effective versus lifestyle modification alone with an incremental cost-effectiveness ratio of $23,432/QALY. ESG remained cost-effective in all sensitivity analyses we conducted and was dominant in analyses with longer time horizons., Conclusion: ESG is a cost-effective treatment option for people living with obesity and should be considered in commercial health plans as an additional treatment option for clinically eligible patients., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: High levels of maternal morbidity and mortality persist in low- and middle-income countries, despite increases in coverage of facility delivery and skilled assistance at delivery. We compared levels of facility birth to a summary delivery care measure and quantified gaps., Methods: We approximated a delivery care score from type of delivery (home, lower-level facility, or hospital), skilled attendant at delivery, a stay of 24-or-more-hours after delivery, and a health check within 48-h after delivery. Data were obtained from 333,316 women aged 15-49 who had a live birth in the previous 2 years, and from 71 countries with nationally representative surveys between 2013 and 2020. We computed facility delivery and delivery care coverage estimates to assess the gap. We stratified the analysis by country characteristics, including the national maternal mortality ratio (MMR), to assess the size of coverage gaps, and we assessed missed opportunities through coverage cascades. We looked at the association between MMR and delivery care coverage., Results: Delivery care coverage varied by country, ranging from 24% in Sudan to 100% in Cuba. Median coverage was 70% with an interquartile range of 30 percentage points (55% and 85%). The cascade showed that while 76% of women delivered in a facility, only 41% received all four interventions. Coverage gaps exist across all MMR levels. Gaps between highest and lowest wealth quintiles were greatest in countries with MMR levels of 100 or higher, and the gap narrowed in countries with MMR levels below 100. The delivery care indicator had a negative association with MMR., Conclusions: In addition to providing high-quality evidenced-based care to women during birth and the postpartum period, there is also a need to address gaps in delivery care, which occur within and between countries, wealth quintiles, and MMR phases., (© 2024. The Author(s).)

Introduction: Endoscopy prior to bariatric surgery is not always performed, and in sleeve gastrectomy (SG), the surgical specimen is not always sent for pathological examination. There is limited data on the frequency of clinically significant findings in SG specimens or correlation with preoperative endoscopy., Methods: We reviewed 426 consecutive SG patients to determine the concordance of preoperative endoscopy findings in patients with clinically significant postoperative pathology., Results: Preoperative endoscopy was performed on 397 patients (93.2%). Three hundred seventy-three patients had preoperative endoscopy and surgical pathology results available. Then, 20/373 (5.4%) patients had potentially significant postoperative pathology, including intestinal metaplasia, autoimmune metaplastic atrophic gastritis (AMAG), gastrointestinal stromal tumors, and/or gastric cancer. The overall incidence of AMAG in the entire cohort was 2.3%. Preoperative gastric biopsies (to include gastric body) identified AMAG in nearly 1/2 of patients. Patients with clinically significant postoperative pathology results had a median [interquartile range] of 3 [3-5] tissue blocks examined as compared to 3 [1-3] for the remainder of the cohort (p < 0.001)., Conclusion: This is one of the largest studies describing clinically significant postoperative pathology after SG. AMAG, in particular, is of particular importance as it is associated with a 3-fivefold increase in risk for gastric cancer. The incidence of significant postoperative pathology in this population is small but potentially clinically significant and requires validation in larger studies. We recommend wider sampling in preoperative endoscopy (body and antrum), especially in patients being planned for gastric bypass, consideration for routine pathological examination of SG surgical specimens, with careful gross examination and targeted sampling., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Whether the benefits of the robotic platform in bariatric surgery translate into superior surgical outcomes remains unclear. The aim of this retrospective study was to establish the 'best possible' outcomes for robotic bariatric surgery and compare them with the established laparoscopic benchmarks., Methods: Benchmark cut-offs were established for consecutive primary robotic bariatric surgery patients of 17 centres across four continents (13 expert centres and 4 learning phase centres) using the 75th percentile of the median outcome values until 90 days after surgery. The benchmark patients had no previous laparotomy, diabetes, sleep apnoea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, history of thromboembolic events, BMI greater than 50 kg/m2, or age greater than 65 years., Results: A total of 9097 patients were included, who were mainly female (75.5%) and who had a mean(s.d.) age of 44.7(11.5) years and a mean(s.d.) baseline BMI of 44.6(7.7) kg/m2. In expert centres, 13.74% of the 3020 patients who underwent primary robotic Roux-en-Y gastric bypass and 5.9% of the 4078 patients who underwent primary robotic sleeve gastrectomy presented with greater than or equal to one complication within 90 postoperative days. No patient died and 1.1% of patients had adverse events related to the robotic platform. When compared with laparoscopic benchmarks, robotic Roux-en-Y gastric bypass had lower benchmark cut-offs for hospital stay, postoperative bleeding, and marginal ulceration, but the duration of the operation was 42 min longer. For most surgical outcomes, robotic sleeve gastrectomy outperformed laparoscopic sleeve gastrectomy with a comparable duration of the operation. In robotic learning phase centres, outcomes were within the established benchmarks only for low-risk robotic Roux-en-Y gastric bypass., Conclusion: The newly established benchmarks suggest that robotic bariatric surgery may enhance surgical safety compared with laparoscopic bariatric surgery; however, the duration of the operation for robotic Roux-en-Y gastric bypass is longer., (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.)

Multiple myeloma (MM) shows constitutive activation of canonical and noncanonical nuclear factor κB (NF-κB) signaling via genetic mutations or tumor microenvironment (TME) stimulations. A subset of MM cell lines showed dependency for cell growth and survival on the canonical NF-κB transcription factor RELA alone, suggesting a critical role for a RELA-mediated biological program in MM pathogenesis. Here, we determined the RELA-dependent transcriptional program in MM cell lines and found the expression of the cell surface molecules interleukin-27 receptor-α (IL-27Rα) and the adhesion molecule JAM2 to be responsive to RELA at the messenger RNA and protein levels. IL-27Rα and JAM2 were expressed on primary MM cells at higher levels than on healthy long-lived plasma cells (PCs) in the bone marrow. IL-27 activated STAT1, and to a lesser extent STAT3, in MM cell lines and in PCs generated from memory B cells in an IL-21-dependent in vitro PC differentiation assay. Concomitant activity of IL-21 and IL-27 enhanced differentiation into PCs and increased the cell-surface expression of the known STAT target gene CD38. In accordance, a subset of MM cell lines and primary MM cells cultured with IL-27 upregulated CD38 cell-surface expression, a finding with potential implications for enhancing the efficacy of CD38-directed monoclonal antibody therapies by increasing CD38 expression on tumor cells. The elevated expression of IL-27Rα and JAM2 on MM cells compared with that on healthy PCs may be exploited for the development of targeted therapeutic strategies that modulate the interaction of MM cells with the TME., (© 2023 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)

Background: The field of bariatric surgery has seen peaks and troughs in the types of metabolic procedures performed. Our primary aim was to evaluate bariatric case volumes among fellows enrolled in bariatric Fellowship Council (FC)-accredited programs. Our secondary aim was to assess trends in revisional case volumes., Methods: We reviewed de-identified FC case logs for all bariatric surgery-accredited programs from 2010 through 2019. The number of primary sleeve gastrectomy, gastric band, gastric bypass, biliopancreatic diversion, and major revisional bariatric surgical procedures (defined as a revision with creation of a new anastomosis) were graphed for each academic year. Fellows were stratified into quartiles based on the number of revisional operations per year and graphed over ten years. Volumes of primary gastric bypass, major revisions, and total anastomotic cases were compared over time using ANOVA with p < 0.05 considered significant., Results: Case volumes for 822 fellows were evaluated. Sleeve gastrectomy had a significant surge in 2010 and plateaued in 2016. The fellows' number of primary gastric bypasses had a non-significant decrease from 84 to 75 cases/fellow from 2010 to 2019. This decrease was offset by a significant increase in major revisional surgery from 8 to 19 cases/fellow. As a result, the number of anastomotic cases did not change significantly over the study time period. Interestingly, as revisional volume has grown, the gap between quartiles of fellowship programs has widened with the 95th percentile growing at a much faster rate than lower quartiles., Conclusion: The volume of bariatric procedures performed in the last decade among FC fellows follows similar trends to national data. Major revisional cases have doubled with the most robust growth isolated to a small number of programs. As revisional surgery continues to increase, applicants interested in a comprehensive bariatric practice should seek out training programs that offer strong revisional experience., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Utility and usability of laser speckle contrast imaging (LSCI) in detecting real-time tissue perfusion in robot-assisted surgery (RAS) and laparoscopic surgery are not known. LSCI displays a color heatmap of real-time tissue blood flow by capturing the interference of coherent laser light on red blood cells. LSCI has advantages in perfusion visualization over indocyanine green imaging (ICG) including repeat use on demand, no need for dye, and no latency between injection and display. Herein, we report the first-in-human clinical comparison of a novel device combining proprietary LSCI processing and ICG for real-time perfusion assessment during RAS and laparoscopic surgeries., Methods: ActivSight™ imaging module is integrated between a standard laparoscopic camera and scope, capable of detecting tissue blood flow via LSCI and ICG in laparoscopic surgery. From November 2020 to July 2021, we studied its use during elective robotic-assisted and laparoscopic cholecystectomies, colorectal, and bariatric surgeries (NCT# 04633512). For RAS, an ancillary laparoscope with ActivSight imaging module was used for LSCI/ICG visualization. We determined safety, usability, and utility of LSCI in RAS vs. laparoscopic surgery using end-user/surgeon human factor testing (Likert scale 1-5) and compared results with two-tailed t tests., Results: 67 patients were included in the study-40 (60%) RAS vs. 27 (40%) laparoscopic surgeries. Patient demographics were similar in both groups. No adverse events to patients and surgeons were observed in both laparoscopic and RAS groups. Use of an ancillary laparoscopic system for LSCI/ICG visualization had minimal impact on usability in RAS as evidenced by surgeon ratings of device usability (set-up 4.2/5 and form-factor 3.8/5). LSCI ability to detect perfusion (97.5% in RAS vs 100% in laparoscopic cases) was comparable in both RAS and laparoscopic cases., Conclusions: LSCI demonstrates comparable utility and usability in detecting real-time tissue perfusion/blood flow in RAS and laparoscopic surgery., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Robotic Roux-en-Y gastric bypass (RRYGB) is performed in an increasing number of bariatric centers worldwide. Previous studies have identified a number of demographic and clinical variables as predictors of postoperative complications after laparoscopic Roux-en-Y gastric bypass (LRYGB). Some authors have suggested better early postoperative outcomes after RRYGB compared to LRYGB. The objective of the present study was to assess potential predictors of early postoperative complications after RRYGB., Methods: A retrospective analysis of two prospective databases containing patients who underwent RRYGB between 2006 and 2019 at two high volumes, accredited bariatric centers was performed. Primary outcome was rate of 30 day postoperative complications. Relevant demographic, clinical and biological variables were entered in a multivariate, logistic regression analysis to identify potential predictors., Results: Data of 1276 patients were analyzed, including 958 female and 318 male patients. Rates of overall and severe 30 day complications were 12.5% (160/1276) and 3.9% (50/1276), respectively. Rate of 30 day reoperations was 1.6% (21/1276). The overall gastrointestinal leak rate was 0.2% (3/1276). Among various demographic, clinical and biological variables, male sex and ASA score >2 were significantly correlated with an increased risk of 30 day complication rates on multivariate analysis (OR 1.68 and 1.67, p=0.005 and 0.005, respectively)., Conclusion: This study identified male sex and ASA score >2 as independent predictors of early postoperative complications after RRYGB. These data suggest a potentially different risk profile in terms of early postoperative complications after RRYGB compared to LYRGB. The robotic approach might have a benefit for patients traditionally considered to be at higher risk of complications after LRYGB, such as those with BMI >50. The present study was however not designed to assess this hypothesis and larger, prospective studies are necessary to confirm these results., (© 2022. The Author(s).)

Background and study aims  Concomitant hiatal hernia (HH) repair with transoral incisionless fundoplication (TIF) is a therapeutic option for patients with HH > 2 cm and gastroesophageal reflux disease (GERD). Data comparing this approach with laparoscopic Nissen fundoplication (LNF) are lacking. We performed an exploratory analysis to compare these two approaches' adverse events (AEs) and clinical outcomes. Patients and methods  This was a multicenter retrospective cohort study of HH repair followed by LNF versus HH repair followed by TIF in patients with GERD and moderate HH (2-5 cm). AEs were assessed using the Clavien-Dindo classification. Symptoms (heartburn/regurgitation, bloating, and dysphagia) were compared at 6 and 12 months. Results  A total of 125 patients with HH repair with TIF and 70 with HH repair with LNF were compared. There was no difference in rates of discontinuing or decreasing proton pump inhibitor use, dysphagia, esophagitis, disrupted wrap, and HH recurrence between the two groups ( P  > 0.05). The length of hospital stay (1 day vs. 2 days), 30-day readmission rate (0 vs. 4.3 %), early AE rate (0 vs. 18.6 %), and early serious AE rate (0 vs. 4.3 %) favored TIF (all P  < 0.05). The rate of new or worse than baseline bloating was lower in the TIF group at 6 months (13.8 % vs. 30.0 %, P  = 0.009). Conclusions  Concomitant HH repair with TIF is feasible and associated with lower early and serious AEs compared to LNF. Further comparative efficacy studies are warranted., Competing Interests: Competing interests Dr. Abu Dayyeh is a consultant for Metamodix, BFKW, DyaMx, Boston Scientific, USGI medical, Hemostasis, and Endo-TAGSS. He has received research support from Apollo Endosurgery, USGI, Spatz Medical, Boston Scientific, GI Dynamics, Cairn Diagnostics, Aspire Bariatrics, and Medtronic. He has served as a speaker for Johnson & Johnson, EndoGastric Solutions, and Olympus. Dr. Janu is a consultant for EndoGastric Solutions, Ethicon/J&J, and Olympus. Dr. Murray is a consultant for Boston Scientific Corp, Pentax America. He has received research support from Pentax America. He has served as a speaker for AbbVie. He is an advisory board member for Colubris Rx. He has received royalties from UpToDate. Dr. Chang is a consultant for and has received educational research grants from EndoGastric Solutions, is a consultant for and has received educational grants from Cook and Olympus. Dr. Canto has received research support from EndoGastric Solutions and Pentax Medical Corporation and has received royalties from UpToDate., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Exoskeleton devices can reduce metabolic cost, increase walking speed, and augment load-carrying capacity. However, little is known about the effects of powered assistance on the sensory information required to achieve these tasks. To learn how to use an assistive device, humans must integrate novel sensory information into their internal model. This process may be disrupted by challenges to the sensory systems used for posture. We investigated the exoskeleton-induced changes to balance performance and sensory integration during quiet standing. We asked 11 unimpaired adults to perform a virtual reality-based test of sensory integration in balance (VRSIB) on two days while wearing the exoskeleton either unpowered, using proportional myoelectric control, or with regular shoes. We measured postural biomechanics, muscle activity, equilibrium scores, postural control strategy, and sensory ratios. Results showed improvement in balance performance when wearing the exoskeleton on firm ground. The opposite occurred when standing on an unstable platform with eyes closed or when the visual information was non-veridical. The balance performance was equivalent when the exoskeleton was powered versus unpowered in all conditions except when both the support surface and the visual information were altered. We argue that in stable ground conditions, the passive stiffness of the device dominates the postural task. In contrast, when the ground becomes unstable the passive stiffness negatively affects balance performance. Furthermore, when the visual input to the user is non-veridical, exoskeleton assistance can magnify erroneous muscle inputs and negatively impact the user's postural control.

Exoskeleton assistance can reduce metabolic cost and increase preferred walking speed in unimpaired and impaired groups, but individual outcomes are highly variable. Assistance may influence step regulation, leading to individual modulation of gait variability, energetic cost, and balance control. In this study, we aimed to understand the effects of a powered ankle exoskeleton on step regulation and its relationship to self-selected walking speed, cost of transport, and gait variability. We asked 12 unimpaired young adults to walk at their comfortable walking speed on a self-paced treadmill in their regular shoes, with the exoskeleton tracking zero torque, and in two trials using proportional myoelectric control. We measured preferred walking speed, cost of transport (COT), mean and standard deviation of gait parameters, (step length, step time, and step width) and computed long-term correlations via detrended fluctuation analysis (DFA). In all exoskeleton trials, subjects walked significantly slower than in their shoes. However, the COT was equivalent between shoes and both proportional myoelectric control trials. Subjects also increased medio-lateral balance control by increasing their mean step width and reducing both short-term variability and long-term auto-correlation for this parameter. In the second powered trial subjects returned to the levels of control over step width exhibited during regular shoe walking. During the unpowered condition subjects showed a significant association between step width regulation, walking speed, and COT. However, these parameters were not significantly associated when the assistance was turned on. Together, these results demonstrate that the response to assistance is closely related to the stepping strategy, especially in the initial stages of learning.

Background: Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone., Methods: We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21-65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m 2 . Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks., Findings: Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery., Interpretation: ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975., Funding: Apollo Endosurgery, Mayo Clinic., Competing Interests: Declaration of interests BKAD reports a consultant role for Endogenex, Endo-TAGSS, Metamodix, and BFKW; a consultant role and grants or research support from USGI, Spatz Medical, and Boston Scientific; speaker roles for Olympus and Johnson and Johnson; speaker fees and grant or research support from Medtronic and Endogastric Solutions; and research support from Apollo Endosurgery, Cairn Diagnostics, and Aspire Bariatrics. EBW reports grants or research support from Apollo Endosurgery and Activ Surgical; and honoraria from Intuitive, Covidien, Johnson & Johnson, and Gore Medical. RZS reports a consultant role and research support from Boston Scientific, Cook Medical, Olympus, and Lumendi. EJV reports unpaid leadership roles in the American Gastroenterological Association Trainee and Early Career Committee and American College of Gastroenterology and US Food and Drug Administration Related Matters Committee. CCT reports a consultant role for Apollo Endosurgery, Boston Scientific, Enterasense, EnVision Endoscopy, Fractyl, USGI Medical, Medtronic/Covidien, Olympus/Spiration, and GI Dynamics; being an advisory board member for USGI Medical and Fractyl; having received research grant and support from USGI Medical, Apollo Endosurgery, Boston Scientific, ERBE, FujiFilm, Lumendi Olympus/Spiration, Aspire Bariatrics, and GI Dynamics; having served as a general partner for Blueframe Healthcare; having served as a founder for Enterasense, EnVision Endoscopy, and GI Windows; and holding stock and royalties for GI Windows. CGC reports a consultant role for Boston Scientific, Apollo Endosurgery, and Olympus Corporation; a speaker role for Apollo Endosurgery, AbbVie, Boston Scientific, and Olympus; support for attending meetings from Boston Scientific, Apollo Endosurgery, and AbbVie; being a data safety and monitoring board (DSMB) member for BFKW, ERBE, and Nitinotes Surgical. VK reports a consultant role for ERBE, Apollo Endosurgery, Boston Scientific, FujiFilm, and Medtronic. MBU reports a consultant role for Boston Scientific, Cook, and Olympus; a speaker role for Apollo Endosurgery, Gore, Medtronic, and ERBE; and grants from Boston Scientific, Gore, and Medtronic. ACS reports research grant support from Apollo Endosurgery, Boston Scientific, Endogenex, Endo-TAGSS, and Enterasense; and a consultant role for Apollo Endosurgery, Boston Scientific, ERBE Elektromedizin, GI Dynamics, Intuitive Surgical, and Olympus. AJA reports a consultant role for Rhythm Pharmaceuticals, General Mills, and Amgen Pharmaceuticals; and holding shares of Gila Therapeutics and Phenomix Sciences. MM reports grants from Nestle, VectivBio, Zealand, Fresnius Kabi, and Realfood Blends; a consultant role for Baxter; being a DSMB member for EndoBarrier; and a leadership role at Oley Foundation. PJ reports a consultant role for Apollo Endosurgery, Spatz Medical, ERBS, and GI Dynamics; support for attending meetings from Endogastric Solutions; being a DSMB member for Spatz Medical; grants from Boston Scientific and ASGE; and a financial interest in USGI Medical, GI Dynamics, and Fractyl. NSB, TDW, and NZ were members of the DSMB for this study. ARR and CLK provided administrative assistance to the DSMB. CLK reports a leadership role in the American Society of Metabolic and Bariatric Surgery (ASMBS) Advance Practice Providers Committee, a role as co-chair of the ASMBS Programs Committee, and a vice president role with the Texas Association of Bariatric Surgery–Integrated Health. LE received research grant support from Mayo Clinic and is a consultant for Apollo Endosurgery. JA received research grant support from Mayo Clinic and was a consultant for Apollo Endosurgery at the time of the study; currently, JA is employed by Apollo Endosurgery as Senior Director, Global Clinical Affairs. MGN reports a consultant role for Apollo EndoSurgery, GI Dynamics, Keyron, and USGI; and a speaker role with Erbe. NZ was the DSMB chair for this study, and reports a consultant role for Ethicon, Medtronic, Olympus, GI Windows, Apollo Endosurgery, Boheringer, and LivsMed. DB, FB, BCT, AFT, OG, TK, MMC, CD, and KG declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Natural killer (NK) cells protect against intracellular infection and cancer. These properties are exploited in oncolytic virus (OV) therapy, where antiviral responses enhance anti-tumour immunity. We have analysed the mechanism by which reovirus, an oncolytic dsRNA virus, modulates human NK cell activity. Reovirus activates NK cells in a type I interferon (IFN-I) dependent manner, inducing STAT1 and STAT4 signalling in both CD56 dim and CD56 bright NK cell subsets. Gene expression profiling revealed the dominance of IFN-I responses and identified induction of genes associated with NK cell cytotoxicity and cell cycle progression, with distinct responses in the CD56 dim and CD56 bright subsets. However, reovirus treatment inhibited IL-15 induced NK cell proliferation in an IFN-I dependent manner and was associated with reduced AKT signalling. In vivo, human CD56 dim and CD56 bright NK cells responded with similar kinetics to reovirus treatment, but CD56 bright NK cells were transiently lost from the peripheral circulation at the peak of the IFN-I response, suggestive of their redistribution to secondary lymphoid tissue. Coupled with the direct, OV-mediated killing of tumour cells, the activation of both CD56 dim and CD56 bright NK cells by antiviral pathways induces a spectrum of activity that includes the NK cell-mediated killing of tumour cells and modulation of adaptive responses via the trafficking of IFN-γ expressing CD56 bright NK cells to lymph nodes., (© 2022 The Authors. Immunology published by John Wiley & Sons Ltd.)

Background: Postoperative morbidity after laparoscopic bariatric surgery is considered higher for patients undergoing revisional versus primary procedures. The objective of this retrospective cohort study was to compare outcomes between patients undergoing primary versus revisional robotically assisted laparoscopic (RAL) Roux-en-Y gastric bypass (RYGB)., Methods: Data of all patients who underwent RAL primary and revisional RYGB between 2009 and 2019 at two accredited, high-volume bariatric surgery centers-the Memorial Hermann - Texas Medical Center, Houston, TX, and the Tower Health, Reading Hospital, Reading, PA, were analyzed. Primary outcomes were early (< 30 days) and overall postoperative complications. Secondary outcomes included intraoperative complications, operative times, conversions to laparotomy, length of hospital stay, early (< 30 days) postoperative readmissions and deaths., Results: Data of 1072 patients were analyzed, including 806 primary and 266 revisional RAL RYGB procedures. Longer operative times (203 versus 154 min, P < 0.001), increased number of readmissions for oral intolerance (10.5% versus 6.7%, P = 0.046) and higher rate of gastrojejunal stricture (6.4% versus 2.7%, P = 0.013) were found in the revisional group. Gastrointestinal leak rates were 0.2% for the primary versus 1.1% for the revisional group (P = 0.101). Early (< 30 days) reoperations rates were 2.2% for the primary versus 1.1% for the revisional group (P = 0.318). There were no statistically significant differences between groups in overall and severe complication rates., Conclusion: Patients undergoing RAL primary and revisional RYGB had comparable overall outcomes, with a non-significant higher early complication rate in the revisional group. Despite the study being underpowered to detect differences in specific complication rates, the morbidity seen in the revisional RYGB group remains markedly below literature reports of revisional laparoscopic RYGB and might suggest a benefit of robotic assistance. Further prospective studies are needed to confirm these results., (© 2020. The Author(s).)

Introduction/purpose: Some clinical indicators suggest hypercoagulability/hyperaggregability in patients with morbid obesity. Thromboelastography (TEG®) has been used to profile coagulation status in surgical patients. We aimed to assess coagulation profiles in patients with morbid obesity undergoing bariatric surgery by correlating demographic and patient characteristics to pre-operative TEG® values., Materials and Methods: Pre-operative TEG® values from 422 patients undergoing bariatric surgery were evaluated. TEG® results were analyzed by gender, use of medications known to alter the coagulation profile, and body mass index (BMI)., Results: Patients have a mean of 45.03 ± 11.8 years, female (76.3%), and with a mean BMI of 42 kg/m 1 . The overall coagulation profile of female patients was significantly different from males, even in the sub-cohort without use of medications known to alter coagulation. The majority of patients (94%) with a G value > 15 dynes/cm 1 (clot strength) were female. In females, there was no association between BMI and TEG® values; however, in men, there was a statistically significant difference in TEG® values for those with BMI < 40 kg/m 1 compared to those with BMI > 50 kg/m 2 ., Conclusions: TEG®-based analysis of coagulation profiles offers unique insights. Compared to laboratory normal values (R time, angle, maximal amplitude, and G values), patients with morbid obesity may have a tendency for hypercoagulability/hyperaggregability, with mean values at the higher limit. A significant hypercoagulable difference in TEG® values was identified in female as compared to male patients. Male patients with a BMI greater than 50 kg/m 2 were also found to be increasingly hypercoagulable., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Glioblastoma (GBM) is the most aggressive adult glioma with a median survival of 14 months. While standard treatments (safe maximal resection, radiation, and temozolomide chemotherapy) have increased the median survival in favorable O(6)-methylguanine-DNA methyltransferase (MGMT)-methylated GBM (~21 months), a large proportion of patients experience a highly debilitating and rapidly fatal disease. This study examined GBM cellular energetic pathways and blockade using repurposed drugs: the glycolytic inhibitor, namely dicholoroacetate (DCA), and the partial fatty acid oxidation (FAO) inhibitor, namely ranolazine (Rano). Gene expression data show that GBM subtypes have similar glucose and FAO pathways, and GBM tumors have significant upregulation of enzymes in both pathways, compared to normal brain tissue ( p < 0.01). DCA and the DCA/Rano combination showed reduced colony-forming activity of GBM and increased oxidative stress, DNA damage, autophagy, and apoptosis in vitro . In the orthotopic Gl261 and CT2A syngeneic murine models of GBM, DCA, Rano, and DCA/Rano increased median survival and induced focal tumor necrosis and hemorrhage. In conclusion, dual targeting of glycolytic and FAO metabolic pathways provides a viable treatment that warrants further investigation concurrently or as an adjuvant to standard chemoradiation for GBM., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 McKelvey, Wilson, Short, Melcher, Biggs, Diakos and Howell.)

Introduction: In partnership with the Veterans Health Administration, in 2010, the Department of Defense/Veterans Health Administration Pain Management Task Force Final Report recommended a comprehensive pain management plan. Consequently, each Army medical center established an Interdisciplinary Pain Management Clinic (IPMC) for pain treatment, and each IPMC implements a multidisciplinary outpatient functional restoration program (FRP) as an alternative to or in addition to pharmacological therapy. This article reports our first-year FRP results at William Beaumont Army Medical Center IPMC., Materials and Methods: The FRP is designed to improve the participants' functionality and quality of life, both personally and professionally. Service members with chronic pain were evaluated for psychological and physical clearance before enrollment in an intense and structured FRP for 8 hours a day over 3 weeks. The program focused on physical and occupational exercises, yoga, acupuncture, and educational classes regarding pain medications, nutrition, and coping skills. The resulting data were analyzed using paired two-tailed t-tests with a predetermined significance level of 0.05 to examine the participants' mean changes upon completion of the FRP., Results: The pre-post comparison indicated significant improvement after completion of the FRP. The fear-avoidance of physical activities and the fear of movement scores were reduced significantly (P < 0.05); the Canadian occupational performance and satisfaction, physical strength and endurance were improved significantly (P < 0.0001) in sit-to-stand, plank balance, lifting and carrying, and 10-minute 7-to-1 Pyramid tests; however, fear-avoidance of work was not significantly reduced (P = 0.2319)., Conclusions: Because of the lack of randomization and the small number of subjects (N = 32, 7 cohorts), unknown sources of bias may have influenced the results. Despite these limitations, the results from this report support the program's effectiveness and are consistent with the outcomes from FRP programs in other military facilities and in civilian studies., (Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2020. This work is written by US Government employees and is in the public domain in the US.)

Purpose: Roux-en-Y gastric bypass is a common bariatric procedure. Its configuration creates an excluded gastric remnant, which is subject to potential acute complications such as bleeding, perforation, and necrosis., Material and Methods: A retrospective analysis of a prospective database including all patients presenting between 2007 and 2019 to our institution with acute gastric remnant complications after RYGB was performed., Results: Seven patients were included, including 3 hemorrhages, two of which were treated with double-balloon enteroscopy, as well as 3 perforations and 1 necrosis, all of which required emergent surgery. Overall gastric remnant complication rate was 0.3% in this series., Conclusion: Acute gastric remnant complications after RYGB are infrequent, but their diagnosis and management can be challenging. Double-balloon enteroscopy has diagnostic and therapeutic value for selected patients. Emergent surgery remains the standard of care for unstable patients and should not be delayed.

Background: Laparoscopic repair of recurrent as opposed to primary paraesophageal hernias (PEHs) are historically associated with increased peri-operative complication rates, worsened outcomes, and increased conversion rates. The robotic platform may aid surgeons in these complex revision procedures. The aim of this study was to compare the outcomes of patients undergoing robotic assisted laparoscopic (RAL) repair of recurrent as opposed to primary PEHs., Methods: Patients undergoing RAL primary and recurrent PEH repairs from 2009 to 2017 at a single institution were reviewed. Demographics, use of mesh, estimated blood loss, intra-operative complications, conversion rates, operative time, rates of esophageal/gastric injury, hospital length of stay, re-admission/re-operation rates, recurrence, dysphagia, gas bloat, and pre- and post-operative proton pump inhibitor (PPI) use were analyzed. Analysis was accomplished using Chi-square test/Fischer's exact test for categorical variables and the Mann-Whitney U test for continuous variables., Results: There were 298 patients who underwent RAL PEH repairs (247 primary, 51 recurrent). They were followed for a median (interquartile range) of 120 (44, 470) days. There were no significant differences in baseline demographics between groups. Patients in the recurrent PEH group had longer operative times, increased use of mesh, and increased length of hospital stay. They were also less likely to undergo fundoplication. There were no significant differences in estimated blood loss, incidence of intra-operative complications, re-admission rates, incidence of post-operative dysphagia and gas bloat, and incidence of post-operative PPI use. There were no conversions to open operative intervention or gastric/esophageal injury/leaks., Conclusions: Although repair of recurrent PEHs are historically associated with worse outcomes, in this series, RAL recurrent PEH repairs have similar peri-operative and post-operative outcomes as compared to primary PEH repairs. Whether this is secondary to the potential advantages afforded by the robotic platform deserves further study.

In this article, we review the role of robotics in bariatric surgery. After a brief overview of the evolution of minimally invasive bariatric surgery, we discuss possible advantages of robotic systems and subsequently go into more details about each procedure, including adjustable gastric bands, sleeve gastrectomy, Roux-en-Y gastric bypass, and biliopancreatic diversion with duodenal switch. We also discuss outcomes of robotics in reoperative bariatric surgery. Considerations about training are presented as well., Competing Interests: Disclosure E.B. Wilson has received teaching honoraria from Intuitive Surgical. S.K. Shah has received research grant support from Intuitive Surgical., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Glioblastoma (GBM) is an aggressive cancer with a very poor prognosis. Generally viewed as weakly immunogenic, GBM responds poorly to current immunotherapies. To understand this problem more clearly we used a combination of natural killer (NK) cell functional assays together with gene and protein expression profiling to define the NK cell response to GBM and explore immunosuppression in the GBM microenvironment. In addition, we used transcriptome data from patient cohorts to classify GBM according to immunological profiles. We show that glioma stem-like cells, a source of post-treatment tumour recurrence, express multiple immunomodulatory cell surface molecules and are targeted in preference to normal neural progenitor cells by natural killer (NK) cells ex vivo. In contrast, GBM-infiltrating NK cells express reduced levels of activation receptors within the tumour microenvironment, with hallmarks of transforming growth factor (TGF)-β-mediated inhibition. This NK cell inhibition is accompanied by expression of multiple immune checkpoint molecules on T cells. Single-cell transcriptomics demonstrated that both tumour and haematopoietic-derived cells in GBM express multiple, diverse mediators of immune evasion. Despite this, immunome analysis across a patient cohort identifies a spectrum of immunological activity in GBM, with active immunity marked by co-expression of immune effector molecules and feedback inhibitory mechanisms. Our data show that GBM is recognized by the immune system but that anti-tumour immunity is restrained by multiple immunosuppressive pathways, some of which operate in the healthy brain. The presence of immune activity in a subset of patients suggests that these patients will more probably benefit from combination immunotherapies directed against multiple immunosuppressive pathways., (© 2019 The Authors. Clinical & Experimental Immunology published by John Wiley & Sons Ltd on behalf of British Society for Immunology.)

Background: Patients with obesity have a higher risk of trocar site hernia. The objective of the present study was to compare a standard suture passer versus the neoClose ® device for port site fascial closure in patients with obesity undergoing laparoscopic bariatric surgery., Methods: This is a randomized, controlled trial with two parallel arms. Thirty five patients with BMI ≥ 35 kg/m 2 and undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass were randomized to each group. Port site fascial closure for trocars ≥ 10 mm was performed with the neoClose ® device in the study group and the standard suture passer in the control group. Primary outcomes were time required to complete closure and intensity of postoperative pain at the fascial closure sites. Secondary outcomes were intraabdominal needle depth and incidence of trocar site hernia., Results: The use of the neoClose ® device resulted in shorter closure times (20.2 vs 30.0 s, p = 0.0002), less pain (0.3 vs 0.9, p = 0.002) at port closure sites, and decreased needle depth (3.3 cm vs 5.2 cm, p < 0.0001) compared to the standard suture passer. There was no trocar site hernia at the one-year follow-up in either group., Conclusions: Use of the neoClose ® device resulted in faster fascial closure times, decreased intraoperative needle depth, and decreased postoperative abdominal pain at 1 week as compared to the standard suture passer. These data need to be confirmed on larger cohorts of patients with longer follow-up.

AMP-activated kinase (AMPK) is a trimeric protein holoenzyme with kinase activity. AMPK plays an important role in cellular metabolism and is thought to function as a fuel sensor within the cell, exerting kinase activity to activate energy-conserving pathways and simultaneously inhibit energy-consuming pathways. Traditional in vitro methods to measure AMPK activity to test potential agonists or antagonists utilize radiolabeled ATP with a peptide substrate. Although radiolabeling provides a high level of sensitivity, this approach is not ideal for medium to high-throughput screening, dose-response curves, or kinetic analyses. Our protocol utilizes Invitrogen's Z'-LYTE™ Kinase Assay Kit (Ser/Thr 23 Peptide) to measure changes in the enzymatic activity of AMPKɑ2β1γ1 in the presence of a molecular chaperone. The Z'-LYTE™ platform is based on Fluorescence Resonance Energy Transfer (FRET). The AMPK peptide substrate (S/T 23 peptide: MRPRKRQGSVRRRV) is a self-contained FRET system, using coumarin as the donor and fluorescein as the acceptor. When the peptide is phosphorylated, it is sensitive to cleavage by a site-specific protease. The cleavage of the phospho-peptide eliminates the FRET pair, and the ratiometric analysis of FRET is used as an indirect measure of AMPK kinase activity. This method does not require the use of radiolabeling or antibodies and is used in a multi-well format, with high reproducibility and throughput capabilities., Competing Interests: Competing interests There are no conflicts of interest or competing interest.

Background: The utilization of robotic platforms for general surgery procedures such as hernia repair is growing rapidly in the United States. A limited amount of data are available evaluating operative outcomes in comparison to standard laparoscopic surgery. We completed a retrospective review comparing robotic and laparoscopic ventral hernia repair to provide safety and outcomes data to help design a future prospective trial design., Methods: A retrospective review of 215 patients undergoing ventral hernia repair (142 robotic and 73 laparoscopic) was completed at two large academic centers. Primary outcome measure evaluated was recurrence. Secondary outcomes included incidence of primary fascial closure, and surgical site occurrences., Results: Propensity for treatment match comparison demonstrated that robotic repair was associated with a decreased incidence of recurrence (2.1 versus 4.2%, p < 0.001) and surgical site occurrence (4.2 versus 18.8%, p < 0.001). This may be because robotic repair was associated with increased incidence of primary fascial closure (77.1 versus 66.7%, p < 0.01). Analysis of baseline patient populations showed that robotic repairs were completed on patients with lower body mass index (28.1 ± 3.6 versus 34.2 ± 6.4, p < 0.001) and fewer comorbidities., Conclusions: Our retrospective data show that robotic repair was associated with decreased recurrence and surgical site occurrence. However, the differences noted in the patient populations limit the interpretability of these results. As adoption of robotic ventral hernia repair increases, prospective trials need to be designed in order to investigate the efficacy, safety, and cost effectiveness of this evolving technique.

Background and Aims: Many patients who undergo bariatric surgery will experience weight regain and effective strategies are needed to help these patients. A dilated gastrojejunal anastomosis (GJA) has been associated with weight recidivism after Roux-en-Y gastric bypass surgery (RYGB). Endoscopic transoral outlet reduction (TORe) with a full thickness endoscopic suturing device (Overstitch, Apollo Endosurgery, Austin, TX) is a minimally invasive therapeutic option. The primary aim of this project was to examine the safety and long-term efficacy data from three bariatric surgery centers and to conduct a systematic review and meta-analysis of the existing literature., Methods: Patients who underwent TORe with the Overstitch device from Jan 2013 to Nov 2016 at 3 participating bariatric surgery centers were included in the multicenter analysis. For the systematic review and meta-analysis, a comprehensive search of multiple English databases was conducted. Random effects model was used., Results: 130 consecutive patients across three centers underwent TORe with an endolumenal suturing device. These patients (mean age 47; mean BMI 36.8) had experienced 24.6% weight regain from nadir weight after RYGB. Average weight lost at 6, 12, and 18 months after TORe was 9.31 ± 6.7 kg (N = 84), 7.75 ± 8.4  kg (N = 70), 8 ± 8.8 kg (N = 46) (p < 0.01 for all three time points), respectively. The meta-analysis included 330 patients. The pooled weight lost at 12 months was 8.4 kg (95% CI 6.5-10.3) with no significant heterogeneity across included studies (p = 0.07). Overall, 14% of patients experienced nausea, 18% had pain and 8% required a repeat EGD. No serious adverse events reported., Conclusion: When implemented as part of a multidisciplinary intervention, TORe using endolumenal suturing is safe, reproducible, and effective approach to manage weight recidivism after RYGB and should be utilized early in the management algorithm of these patients.

Introduction: Large loop excision of the transformation zone (LLETZ) is a common gynecological treatment for cervical dysplasia but can be challenging to teach. There is no widely adopted simulator for this procedure in Australia, so a new low-fidelity simulator was designed and evaluated., Method: A simulator for a LLETZ procedure was developed. Doctors (N = 29), varied in experience level in gynecology at a tertiary hospital, performed a LLETZ procedure using the simulator. The procedures were filmed, and two independent assessors rated the deidentified videos. The assessment involved a checklist (of crucial procedural steps) and global rating scale to evaluate whether the simulator facilitated the demonstration of LLETZ procedure skills. Participants completed a questionnaire evaluating the performance and utility of the simulator to determine participant perceptions of simulator realism and acceptability., Results: The participant questionnaire revealed positive evaluations of realism and acceptability of the simulator. Performance scores were significantly different across experience levels (P < 0.001) with post hoc pairwise comparison between levels confirming significant differences between each group in assessed simulator performance for global rating scale and overall performance scores. The interrater reliability of the assessors was high (0.84)., Conclusions: A low-fidelity simulator for a LLETZ procedure seems to adequately demonstrate procedural performance reflecting doctor experience level. Participant questionnaire responses were positive, supporting further evaluation of the simulator for use in training.

Background: The Orbera intragastric balloon (IGB) has been approved by the US Food and Drug Administration for use in patients with a body mass index (BMI) between 30 and 40 kg/m 2 and is in wide use worldwide as a primary and bridge obesity management tool. The balloon filling volume (BFV) ranges between 400 and 700 mL of saline. Our objective was to determine whether there is an association between BFV and clinically relevant endpoints, namely weight loss outcomes, balloon tolerability, and adverse events., Methods: A systematic review of studies investigating the use of the Orbera IGB system for obesity treatment was performed. Data was examined using random effects modelling and meta-regression analyses., Results: Forty-four studies (n = 5549 patients) reported BFV and % total body weight loss (TBWL) at 6 months. Pooled %TBWL at 6 months was 13.2% [95% CI 12.3-14.0]. A funnel plot demonstrated a low risk of publication bias. Meta-regression showed no statistically significant association between filling volume and %TBWL at 6 months (p = 0.268). Higher BFV was associated with lower rates of esophagitis (slope = -0.008, p < 0.001) and prosthesis migration (slope = -0.015, p < 0.001). There was no association between BFV and early removal (p = 0.1), gastroesophageal reflux symptom (p = 0.64), or ulcer rates (p = 0.09)., Conclusions: No association was observed between Orbera IGB filling volume and weight loss outcomes. Higher volumes appear to be associated with lower migration and esophagitis rates; thus, a balloon filling volume of 600-650 mL is recommended.