Laparoscopic adjustable gastric banding with liraglutide in adults with obesity and type 2 diabetes (GLIDE): a pilot randomised placebo controlled trial.

INTRODUCTION: Obesity drives type 2 diabetes (T2DM) development. Laparoscopic adjustable gastric banding (LAGB) has lower weight reduction than other bariatric procedures. Liraglutide, a GLP-1 receptor agonist, improves weight and glycaemic control in patients with T2DM. This study aimed to determine the efficacy and safety of liraglutide 1.8 mg in participants undergoing LAGB. METHODS: GLIDE, a pilot randomised, double-blind, placebo-controlled trial, evaluated LAGB with either liraglutide 1.8 mg or placebo in participants with T2DM and obesity. Participants were randomised (1:1) to 6-months therapy post-LAGB, with further 6 months off-treatment follow-up. The primary outcome was change in HbA1c from randomisation to the end of treatment, secondary outcomes included body weight change. A sample size of 58 (29 per group) had 80% power to detect a 0.6% difference in HbA1c between groups. RESULTS: Twenty-seven participants were randomised to liraglutide (n = 13) or placebo (n = 14). Multivariate analysis showed no difference between placebo and liraglutide arms in HbA1c at 6 months (HbA1c:0.2 mmol/mol, -11.3, 11.6, p = 0.98) however, at 12 months HbA1c was significantly higher in the liraglutide arm (HbA1c:10.9 mmol/mol, 1.1, 20.6, p = 0.032). There was no difference between arms in weight at 6 months (BW:2.0 kg, -4.2, 8.1, p = 0.50), however, at 12 months weight was significantly higher in the liraglutide arm (BW:8.2 kg, 1.6, 14.9, p = 0.02). There were no significant differences in adverse events between groups. CONCLUSIONS: Our pilot data suggest no additional improvement in glycaemic control or BW with LAGB and liraglutide therapy. However, this trial was significantly underpowered to detect a significant change in the primary or secondary outcomes. Further trials are needed to investigate whether GLP-1 agonists, and particularly with more effective weekly agents (i.e. semaglutide or tirzepatide), are of benefit following metabolic surgery. CLINICAL TRIAL REGISTRATION: EudraCT number 2015-005402-11.

Identification of the source events for aerosol generation during oesophago-gastro-duodenoscopy.

OBJECTIVE: To determine if oesophago-gastro-duodenoscopy (OGD) generates increased levels of aerosol in conscious patients and identify the source events. DESIGN: A prospective, environmental aerosol monitoring study, undertaken in an ultraclean environment, on patients undergoing OGD. Sampling was performed 20 cm away from the patient's mouth using an optical particle sizer. Aerosol levels during OGD were compared with tidal breathing and voluntary coughs within subject. RESULTS: Patients undergoing bariatric surgical assessment were recruited (mean body mass index 44 and mean age 40 years, n=15). A low background particle concentration in theatres (3 L-1) enabled detection of aerosol generation by tidal breathing (mean particle concentration 118 L-1). Aerosol recording during OGD showed an average particle number concentration of 595 L-1 with a wide range (3-4320 L-1). Bioaerosol-generating events, namely, coughing or burping, were common. Coughing was evoked in 60% of the endoscopies, with a greater peak concentration and a greater total number of sampled particles than the patient's reference voluntary coughs (11 710 vs 2320 L-1 and 780 vs 191 particles, n=9 and p=0.008). Endoscopies with coughs generated a higher level of aerosol than tidal breathing, whereas those without coughs were not different to the background. Burps also generated increased aerosol concentration, similar to those recorded during voluntary coughs. The insertion and removal of the endoscope were not aerosol generating unless a cough was triggered. CONCLUSION: Coughing evoked during OGD is the main source of the increased aerosol levels, and therefore, OGD should be regarded as a procedure with high risk of producing respiratory aerosols. OGD should be conducted with airborne personal protective equipment and appropriate precautions in those patients who are at risk of having COVID-19 or other respiratory pathogens.

Identifying molecular mediators of the relationship between body mass index and endometrial cancer risk: a Mendelian randomization analysis.

BACKGROUND: Endometrial cancer is the most common gynaecological cancer in high-income countries. Elevated body mass index (BMI) is an established modifiable risk factor for this condition and is estimated to confer a larger effect on endometrial cancer risk than any other cancer site. However, the molecular mechanisms underpinning this association remain unclear. We used Mendelian randomization (MR) to evaluate the causal role of 14 molecular risk factors (hormonal, metabolic and inflammatory markers) in endometrial cancer risk. We then evaluated and quantified the potential mediating role of these molecular traits in the relationship between BMI and endometrial cancer using multivariable MR. METHODS: Genetic instruments to proxy 14 molecular risk factors and BMI were constructed by identifying single-nucleotide polymorphisms (SNPs) reliably associated (P < 5.0 × 10-8) with each respective risk factor in previous genome-wide association studies (GWAS). Summary statistics for the association of these SNPs with overall and subtype-specific endometrial cancer risk (12,906 cases and 108,979 controls) were obtained from a GWAS meta-analysis of the Endometrial Cancer Association Consortium (ECAC), Epidemiology of Endometrial Cancer Consortium (E2C2) and UK Biobank. SNPs were combined into multi-allelic models and odds ratios (ORs) and 95% confidence intervals (95% CIs) were generated using inverse-variance weighted random-effects models. The mediating roles of the molecular risk factors in the relationship between BMI and endometrial cancer were then estimated using multivariable MR. RESULTS: In MR analyses, there was strong evidence that BMI (OR per standard deviation (SD) increase 1.88, 95% CI 1.69 to 2.09, P = 3.87 × 10-31), total testosterone (OR per inverse-normal transformed nmol/L increase 1.64, 95% CI 1.43 to 1.88, P = 1.71 × 10-12), bioavailable testosterone (OR per natural log transformed nmol/L increase: 1.46, 95% CI 1.29 to 1.65, P = 3.48 × 10-9), fasting insulin (OR per natural log transformed pmol/L increase: 3.93, 95% CI 2.29 to 6.74, P = 7.18 × 10-7) and sex hormone-binding globulin (SHBG, OR per inverse-normal transformed nmol/L increase 0.71, 95% CI 0.59 to 0.85, P = 2.07 × 10-4) had a causal effect on endometrial cancer risk. Additionally, there was suggestive evidence that total serum cholesterol (OR per mg/dL increase 0.90, 95% CI 0.81 to 1.00, P = 4.01 × 10-2) had an effect on endometrial cancer risk. In mediation analysis, we found evidence for a mediating role of fasting insulin (19% total effect mediated, 95% CI 5 to 34%, P = 9.17 × 10-3), bioavailable testosterone (15% mediated, 95% CI 10 to 20%, P = 1.43 × 10-8) and SHBG (7% mediated, 95% CI 1 to 12%, P = 1.81 × 10-2) in the relationship between BMI and endometrial cancer risk. CONCLUSIONS: Our comprehensive MR analysis provides insight into potential causal mechanisms linking BMI with endometrial cancer risk and suggests targeting of insulinemic and hormonal traits as a potential strategy for the prevention of endometrial cancer.

Food Intake Following Gastric Bypass Surgery: Patients Eat Less but Do Not Eat Differently.

BACKGROUND: Lack of robust research methodology for assessing ingestive behavior has impeded clarification of the mediators of food intake following gastric bypass (GBP) surgery. OBJECTIVES: To evaluate changes in directly measured 24-h energy intake (EI), energy density (ED) (primary outcomes), eating patterns, and food preferences (secondary outcomes) in patients and time-matched weight-stable comparator participants. METHODS: Patients [n = 31, 77% female, BMI (in kg/m2) 45.5 ± 1.3] and comparators (n = 32, 47% female, BMI 27.2 ± 0.8) were assessed for 36 h under fully residential conditions at baseline (1 mo presurgery) and at 3 and 12 mo postsurgery. Participants had ad libitum access to a personalized menu (n = 54 foods) based on a 6-macronutrient mix paradigm. Food preferences were assessed by the Leeds Food Preference Questionnaire. Body composition was measured by whole-body DXA. RESULTS: In the comparator group, there was an increase in relative fat intake at 3 mo postsurgery; otherwise, no changes were observed in food intake or body composition. At 12 mo postsurgery, patients lost 27.7 ± 1.6% of initial body weight (P < 0.001). The decline in EI at 3 mo postsurgery (-44% from baseline, P < 0.001) was followed by a partial rebound at 12 mo (-18% from baseline), but at both times, dietary ED and relative macronutrient intake remained constant. The decline in EI was due to eating the same foods as consumed presurgery and by decreasing the size (g, MJ), but not the number, of eating occasions. In patients, reduction in explicit liking at 3 mo (-11.56 ± 4.67, P = 0.007) and implicit wanting at 3 (-15.75 ± 7.76, P = 0.01) and 12 mo (-15.18 ± 6.52, P = 0.022) for sweet foods were not matched by reduced intake of these foods. Patients with the greatest reduction in ED postsurgery reduced both EI and preference for sweet foods. CONCLUSIONS: After GBP, patients continue to eat the same foods but in smaller amounts. These findings challenge prevailing views about the dynamics of food intake following GBP surgery. This trial was registered as clinicaltrials.gov as NCT03113305.

Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations: A 2021 Update.

BACKGROUND: This is the second updated Enhanced Recovery After Surgery (ERAS®) Society guideline, presenting a consensus for optimal perioperative care in bariatric surgery and providing recommendations for each ERAS item within the ERAS® protocol. METHODS: A principal literature search was performed utilizing the Pubmed, EMBASE, Cochrane databases and ClinicalTrials.gov through December 2020, with particular attention paid to meta-analyses, randomized controlled trials and large prospective cohort studies. Selected studies were examined, reviewed and graded according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. After critical appraisal of these studies, the group of authors reached consensus regarding recommendations. RESULTS: The quality of evidence for many ERAS interventions remains relatively low in a bariatric setting and evidence-based practices may need to be extrapolated from other surgeries. CONCLUSION: A comprehensive, updated evidence-based consensus was reached and is presented in this review by the ERAS® Society.

Higher body mass index raises immature platelet count: potential contribution to obesity-related thrombosis.

Higher body mass index (BMI) is a risk factor for thrombosis. Platelets are essential for hemostasis but contribute to thrombosis when activated pathologically. We hypothesized that higher BMI leads to changes in platelet characteristics, thereby increasing thrombotic risk. The effect of BMI on platelet traits (measured by Sysmex) was explored in 33 388 UK blood donors (INTERVAL study). Linear regression showed that higher BMI was positively associated with greater plateletcrit (PCT), platelet count (PLT), immature platelet count (IPC), and side fluorescence (SFL, a measure of mRNA content used to derive IPC). Mendelian randomization (MR), applied to estimate a causal effect with BMI proxied by a genetic risk score, provided causal estimates for a positive effect of BMI on both SFL and IPC, but there was little evidence for a causal effect of BMI on PCT or PLT. Follow-up analyses explored the functional relevance of platelet characteristics in a pre-operative cardiac cohort (COPTIC). Linear regression provided observational evidence for a positive association between IPC and agonist-induced whole blood platelet aggregation. Results indicate that higher BMI raises the number of immature platelets, which is associated with greater whole blood platelet aggregation in a cardiac cohort. Higher IPC could therefore contribute to obesity-related thrombosis.

Gut hormones profile after an Ivor Lewis gastro-esophagectomy and its relationship to delayed gastric emptying.

Delayed gastric emptying (DGE) is common after an Ivor Lewis gastro-esophagectomy (ILGO). The risk of a dilated conduit is the much-feared anastomotic leak. Therefore, prompt management of DGE is required. However, the pathophysiology of DGE is unclear. We proposed that post-ILGO patients with/without DGE have different gut hormone profiles (GHP). Consecutive patients undergoing an ILGO from 1 December 2017 to 31 November 2019 were recruited. Blood sampling was conducted on either day 4, 5, or 6 with baseline sample taken prior to a 193-kcal meal and after every 30 minutes for 2 hours. If patients received pyloric dilatation, a repeat profile was performed post-dilatation and were designated as had DGE. Analyses were conducted on the following groups: patient without dilatation (non-dilated) versus dilatation (dilated); and pre-dilatation versus post-dilatation. Gut hormone profiles analyzed were glucagon-like peptide-1 (GLP-1) and peptide tyrosine tyrosine (PYY) using radioimmunoassay. Of 65 patients, 24 (36.9%) had dilatation and 41 (63.1%) did not. For the non-dilated and dilated groups, there were no differences in day 4, 5, or 6 GLP-1 (P = 0.499) (95% confidence interval for non-dilated [2822.64, 4416.40] and dilated [2519.91, 3162.32]). However, PYY levels were raised in the non-dilated group (P = 0.021) (95% confidence interval for non-dilated [1620.38, 3005.75] and dilated [821.53, 1606.18]). Additionally, after pyloric dilatation, paired analysis showed no differences in GLP-1, but PYY levels were different at all time points and had an exaggerated post-prandial response. We conclude that DGE is associated with an obtunded PYY response. However, the exact nature of the association is not yet established.

Defining Global Benchmarks in Bariatric Surgery: A Retrospective Multicenter Analysis of Minimally Invasive Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.

OBJECTIVE: To define "best possible" outcomes for bariatric surgery (BS)(Roux-en-Y gastric bypass [RYGB] and sleeve gastrectomy [SG]). BACKGROUND: Reference values for optimal surgical outcomes in well-defined low-risk bariatric patients have not been established so far. Consequently, outcome comparison across centers and over time is impeded by heterogeneity in case-mix. METHODS: Out of 39,424 elective BS performed in 19 high-volume academic centers from 3 continents between June 2012 and May 2017, we identified 4120 RYGB and 1457 SG low-risk cases defined by absence of previous abdominal surgery, concomitant procedures, diabetes mellitus, sleep apnea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, anticoagulation, BMI>50 kg/m and age>65 years. We chose clinically relevant endpoints covering the intra- and postoperative course. Complications were graded by severity using the comprehensive complication index. Benchmark values were defined as the 75th percentile of the participating centers' median values for respective quality indicators. RESULTS: Patients were mainly females (78%), aged 38±11 years, with a baseline BMI 40.8 ±â€Š5.8 kg/m. Over 90 days, 7.2% of RYGB and 6.2% of SG patients presented at least 1 complication and no patients died (mortality in nonbenchmark cases: 0.06%). The most frequent reasons for readmission after 90-days following both procedures were symptomatic cholelithiasis and abdominal pain of unknown origin. Benchmark values for both RYGB and SG at 90-days postoperatively were 5.5% Clavien-Dindo grade ≥IIIa complication rate, 5.5% readmission rate, and comprehensive complication index ≤33.73 in the subgroup of patients presenting at least 1 grade ≥II complication. CONCLUSION: Benchmark cutoffs targeting perioperative outcomes in BS offer a new tool in surgical quality-metrics and may be implemented in quality-improvement cycle.ClinicalTrials.gov Identifier NCT03440138.

Assessing the quality of primary care referrals to surgery of patients with diabetes in the East of England: A multi-centre cross-sectional cohort study.

AIM: Peri-operative hyperglycaemia is associated with an increased incidence of adverse outcomes. Communication between primary and secondary care is paramount to minimise these harms. National guidance in the UK recommends that the glycated haemoglobin (HbA1c) should be measured within 3 months prior to surgery and that the concentration should be less that 69 mmol/mol (8.5%). In addition, national guidance outlines the minimum dataset that should be included in any letter at the time of referral to the surgeons. Currently, it is unclear how well this process is being carried out. This study investigated the quality of information being handed over during the referral from primary care to surgical outpatients within the East of England. METHODS: Primary care referrals to nine different NHS hospital Trusts were gathered over a 1-week period. All age groups were included from 11 different surgical specialties. Referral letters were analysed using a standardised data collection tool based on the national guidelines. RESULTS: A total of 1919 referrals were received, of whom 169 (8.8%) had previously diagnosed diabetes mellitus (DM). However, of these, 38 made no mention of DM in the referral letter but were on glucose-lowering agents. Only 13 (7.7%) referrals for patients with DM contained a recent HbA1c, and 20 (11.8%) contained no documentation of glucose-lowering medication. CONCLUSION: This study has shown that the quality of referral letters to surgical specialties for patients with DM in the East of England remain inadequate. There is a clear need for improving the quality of clinical data contained within referral letters from primary care. In addition, we have shown that the rate of referral for surgery for people with diabetes is almost 50% higher than the background population with diabetes.

An evaluation of operative self-assessment by UK postgraduate trainees.

BACKGROUND: Surgeons in training undertake procedure-based assessment (PBA) with their trainers. Time pressures limit when this occurs. Self-assessment would provide additional opportunities but requires evaluation of your own skills and knowledge. AIM: To investigate the validity of a self-assessment PBA in the operating theatre and evaluate learning needs and change in practice identified. METHODS: In a prospective study, postgraduate UK trainees performed a self-assessment PBA after formally reflecting on appendicectomy surgery. Later, they performed their usual external assessment PBA on the same case and outcomes were compared. Learning outcomes were analysed independently by two trainers. RESULTS: There were 25 trainees (14 males), of age 29 years (25-33). They had performed a median of five previous appendicectomies (2-21) after a median three years of speciality training (range 1-4). There were no significant differences in global summary scores, trainee satisfaction or learning outcomes between external and self-assessment PBAs. Construct validity of the self-assessment PBA was demonstrated. The self-assessment PBA was more likely to identify non-technical skills. CONCLUSION: Our results suggest self-assessment PBA is valid for formative assessment. It identified a wide range of learning outcomes. Self-assessment PBA would help trainees maximise every learning opportunity and practice self-assessment skills.

Minimally Invasive Extended Totally Extraperitoneal Versus Transabdominal Retromuscular Ventral Hernia Mesh Repair: Systematic Review and Meta-Analysis.

Introduction: Minimally invasive surgery for ventral hernia repair (MIS-VHR) with mesh in retromuscular plane can be performed by either transabdominally (TA-RM) or via enhanced view totally extraperitoneal approach (eTEP). Although both techniques offer the mesh extension in the best anatomical space, closure of hernia defect, avoidance of traumatic fixation, the superiority of one approach over another is not established. This systematic review and meta-analysis were set up to analyze safety and efficacy of eTEP in comparison with TA-RM. Materials and Methods: Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) framework was used as guideline to conduct systematic search of literature. Studies that provided comparative data of MIS-VHR using eTEP versus TA-RM were identified. Primary outcomes were major complications. These were defined as grade III-IV according to Clavien-Dindo classification. Secondary outcomes included: surgical site infection (SSI) rates, seroma rates, surgical site occurrence requiring procedural intervention (SSOPI), minor complications (Clavien-Dindo grade I-II), intraoperative complications, recurrence rate, postoperative ileus, duration of surgery, postoperative pain. Random- and fixed-effects models of statistical analysis were used. Risk difference (RD) was computated for binary outcomes (major and minor complications, SSI, seroma, SSOPI, recurrence, ileus) with 95% confidence intervals. I2 test was used to assess statistical heterogeneity. Risk of bias assessment was performed using Newcastle-Ottawa framework. Results: There were 3 observational studies that enrolled 370 participants. In the eTEP group there were 166 patients and, in the TA-RM group there were 204 patients. There was no significant RD with regard to major complications (RD -0.02 [-0.06 to 0.02], test for overall effect: Z = 0.86 [P = .39]). There was no significant RD in occurrence of minor complications, SSI, seroma, SSOPI, recurrence, ileus. Conclusions: Both eTEP and TA-RM were found to have equal safety profile. Further high-quality studies evaluating patient reported outcomes and late recurrence may be useful. PROSPERO registration number: CRD42023429160.

Sex, race, and BMI in clinical trials of medications for obesity over the past three decades: a systematic review.

Medications for obesity have been studied in various populations over the past three decades. We aimed to quantify the baseline demographic characteristics of BMI, sex, age, and race in randomised clinical trials (RCTs) across three decades to establish whether the population studied is representative of the global population affected by the disease. Clinical trials of 12 medications for obesity (ie, orlistat, naltrexone-bupropion, topiramate-phentermine, liraglutide, semaglutide, lorcaserin, sibutramine, rimonabant, taranabant, tirzepatide, retatrutide, and orforglipron) published from Jan 20, 1999, to Nov 12, 2023, were assessed through a systematic review for methodological quality and baseline demographic characteristics. 246 RCTs were included, involving 139 566 participants with or without type 2 diabetes. Most trials over-recruited White, female participants aged 40 years or older with class 1 (30·0-34·9 kg/m2) and class 2 (35·0-39·9 kg/m2) obesity; older participants, those with class 3 (≥40·0 kg/m2) obesity, non-White participants, and male participants were under-recruited. Our systematic review suggests that future trials need to recruit traditionally under-represented populations to allow for accurate measures of efficacy of medications for obesity, enabling more informed decisions by clinicians. It is also hoped that these data will help to refine trial recruitment strategies to ensure that future studies are relevant to the population affected by obesity.

Perceived Benefits of Bariatric Surgery: Patient Perspectives.

BACKGROUND: Obesity is a chronic and complex disease characterized by the excessive accumulation of adipose tissue, which has detrimental effects on health. Evaluating the changes in quality of life (QoL) after bariatric surgery complements the medical benefits which are documented by healthcare professionals. PURPOSE: To study the perceived health benefits 1 year after substantial weight loss induced by bariatric surgery. METHODS: This pilot study evaluated patients 1 year after bariatric surgery using 13 questions related to the health domains of the KOSS: airway, body mass, cardiovascular risk, diabetes, economic impact, functional, gonadal impact, health status perceived, image, junction of the gastro-esophagus, kidney, liver, and medication. In addition, the patients were asked to score the most significant benefit as "1," while the least beneficial benefit was scored as "13." RESULTS: One hundred fourteen consecutive patients were evaluated (men = 37 and women = 77). The responses were divided into functional, metabolic, and mental/social benefits. Patients ranked the functional question, "I became more active, and I can do more things" as the most important (average score of 3.7 ± 0.2), followed by a question related to metabolic status: "I am less worried about my risk of heart disease" (4.5 ± 0.3), and then a social/mental question, "My clothes fit better" (5.4 ± 0.3). The three least valuable benefits for the cohort were sexual life improvements (8.9 ± 0.3), heartburn improvements (9.0 ± 0.3), and urinary incontinence improvements (9.8 ± 0.3). CONCLUSIONS: Our observational pilot study demonstrated that patients value functional benefits after substantial weight loss the most, but that metabolic benefits and social/mental health benefits are also considered important.

Role of vitamin D supplementation in modifying outcomes after surgery: a systematic review of randomised controlled trials.

BACKGROUND: There is increasing evidence to suggest vitamin D plays a role in immune and vascular function; hence, it may be of biological and clinical relevance for patients undergoing major surgery. With a greater number of randomised studies being conducted evaluating the impact of vitamin D supplementation on surgical patients, it is an opportune time to conduct further analysis of the impact of vitamin D on surgical outcomes. METHODS: MEDLINE, EMBASE and the Cochrane Trials Register were interrogated up to December 2023 to identify randomised controlled trials of vitamin D supplementation in surgery. The risk of bias in the included studies was assessed using the Cochrane Risk of Bias tool. A narrative synthesis was conducted for all studies. The primary outcome assessed was overall postoperative survival. RESULTS: We screened 4883 unique studies, assessed 236 full-text articles and included 14 articles in the qualitative synthesis, comprising 1982 patients. The included studies were highly heterogeneous with respect to patient conditions, ranging from open heart surgery to cancer operations to orthopaedic conditions, and also with respect to the timing and equivalent daily dose of vitamin D supplementation (range: 0.5-7500 mcg; 20-300 000 IU). No studies reported significant differences in overall survival or postoperative mortality with vitamin D supplementation. There was also no clear evidence of benefit with respect to overall or intensive care unit length of stay. DISCUSSION: Numerous studies have reported the benefits of vitamin D supplementation in different surgical settings without any consistency. However, this systematic review found no clear evidence of benefit, which warrants the supposition that a single biological effect of vitamin D supplementation does not exist. The observed improvement in outcomes in low vitamin D groups has not been convincingly proven beyond chance findings. TRIAL REGISTRATION NUMBER: CRD42021232067.

Development of a Bariatric Surgery Core Data Set for an International Registry.

PURPOSE: Bariatric and metabolic surgery is an effective treatment for severe and complex obesity; however, robust long-term data comparing operations is lacking. Clinical registries complement clinical trials in contributing to this evidence base. Agreement on standard data for bariatric registries is needed to facilitate comparisons. This study developed a Core Registry Set (CRS) - core data to include in bariatric surgery registries globally. MATERIALS AND METHODS: Relevant items were identified from a bariatric surgery research core outcome set, a registry data dictionary project, systematic literature searches, and a patient advisory group. This comprehensive list informed a questionnaire for a two-round Delphi survey with international health professionals. Participants rated each item's importance and received anonymized feedback in round 2. Using pre-defined criteria, items were then categorized for voting at a consensus meeting to agree the CRS. RESULTS: Items identified from all sources were grouped into 97 questionnaire items. Professionals (n = 272) from 56 countries participated in the round 1 survey of which 45% responded to round 2. Twenty-four professionals from 13 countries participated in the consensus meeting. Twelve items were voted into the CRS including demographic and bariatric procedure information, effectiveness, and safety outcomes. CONCLUSION: This CRS is the first step towards unifying bariatric surgery registries internationally. We recommend the CRS is included as a minimum dataset in all bariatric registries worldwide. Adoption of the CRS will enable meaningful international comparisons of bariatric operations. Future work will agree definitions and measures for the CRS including incorporating quality-of-life measures defined in a parallel project.

Weight Management Interventions for Adults With Idiopathic Intracranial Hypertension: A Systematic Review and Practice Recommendations.

BACKGROUND AND OBJECTIVES: Idiopathic intracranial hypertension (IIH) is associated with obesity; however, there is a lack of clinical consensus on how to manage weight in IIH. The aim of this systematic review was to evaluate weight loss interventions in people with IIH to determine which intervention is superior in terms of weight loss, reduction in intracranial pressure (ICP), benefit to visual and headache outcomes, quality of life, and mental health. METHODS: A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered with PROSPERO (CRD42023339569). MEDLINE and CINAHL were searched for relevant literature published from inception until December 15, 2022. Screening and quality appraisal was conducted by 2 independent reviewers. Recommendations were graded using Scottish Intercollegiate Guidelines Network methodology. RESULTS: A total of 17 studies were included. Bariatric surgery resulted in 27.2-27.8 kg weight loss at 24 months (Level 1- to 1++). Lifestyle weight management interventions resulted in between 1.4 and 15.7 kg weight loss (Level 2+ to 1++). Bariatric surgery resulted in the greatest mean reduction in ICP (-11.9 cm H2O) at 24 months (Level 1++), followed by multicomponent lifestyle intervention + acetazolamide (-11.2 cm H2O) at 6 months (Level 1+) and then a very low-energy diet intervention (-8.0 cm H2O) at 3 months (Level 2++). The least ICP reduction was shown at 24 months after completing a 12-month multicomponent lifestyle intervention (-3.5 cm H2O) (Level 1++). Reduction in body weight was shown to be highly correlated with reduction in ICP (Level 2++ to 1++). DISCUSSION: Bariatric surgery should be considered for women with IIH and a body mass index (BMI) ≥35 kg/m2 since this had the most robust evidence for sustained weight management (grade A). A multicomponent lifestyle intervention (diet + physical activity + behavior) had the most robust evidence for modest weight loss with a BMI <35 kg/m2 (grade B). Longer-term outcomes for weight management interventions in people with IIH are required to determine whether there is a superior weight loss intervention for IIH.

Say what you mean, mean what you say: The importance of language in the treatment of obesity.

OBJECTIVE: Obesity is a highly stigmatized disease, and despite the understanding of the processes involved, negative language reinforcing outdated views of obesity persists within the scientific literature. This is the first study, to the authors' knowledge, to determine how widespread stigmatizing language is within publications on obesity and examine its impact on patients. METHODS: Two standard terms within obesity publications were identified, and a literature search was carried out to determine their prevalence. A parallel qualitative analysis was conducted with patients with obesity to determine perceptions of these terms. RESULTS: Of the 3,020 papers screened, 2.4% included the term fail, and 16.8% contained morbid used in conjunction with obesity. Sixteen patients participated in the qualitative analysis. They felt that negative language, particularly failure, implied a personal responsibility for lack of weight loss. Clinically meaningful terminology fostered a more constructive relationship with health care providers. CONCLUSIONS: Although most journals object to overtly stigmatizing language, using phrases or words that carry negative connotations is less clearly discouraged. It is important to recognize that language that implies a moral responsibility for weight loss or the development of obesity contradicts the well-established evidence base that obesity results from complex biological processes.

Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study.

INTRODUCTION: Bariatric surgery is an effective method of controlling glycaemia in patients with type 2 diabetes mellitus (T2DM) and obesity. Long-term studies suggest that although glycaemic control remains good, only 20%-40% of patients will maintain remission according to the American Diabetes Association criteria. PURPOSE: This trial aims to examine the safety and efficacy of combining Roux-en-Y gastric bypass or sleeve gastrectomy with goal-directed medical therapy to improve long-term glycaemic control of T2DM. METHODS AND ANALYSIS: This prospective, open-label multicentre randomised controlled trial (RCT) will recruit 150 patients with obesity and T2DM from tertiary care obesity centres. Patients will be randomised 1:1 to receive either bariatric surgery and standard medical care or bariatric surgery and intensive goal-directed medical therapy, titrated to specific targets for glycated haemoglobin (HbA1c), blood pressure (BP) and low-density lipoproteins (LDL) cholesterol. The primary endpoints are the proportion of patients in each arm with an HbA1c<6.5% (48 mmol/mol) at 1 year and the proportion of patients in each arm achieving the composite endpoint of HbA1c<6.5% (48 mmol/mol), BP<130/80 mm Hg and LDL<2.6 mmol/L at 5 years. ETHICS AND DISSEMINATION: The local institutional review board approved this study. This study represents the first RCT to examine the safety and efficacy of combining bariatric surgery with intensive medical therapy compared with bariatric surgery and usual care for long-term diabetes control. TRIAL REGISTRATION NUMBER: NCT04432025.