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Bariatric surgery, the most effective treatment for obesity and type 2 diabetes, is associated with increased levels of the incretin hormone glucagon-like peptide-1 (GLP-1) and changes in levels of circulating bile acids. The levels of individual bile acids in the gastrointestinal (GI) tract after surgery have, however, remained largely unstudied. Using ultra-high performance liquid chromatography-mass spectrometry-based quantification, we observed an increase in an endogenous bile acid, cholic acid-7-sulfate (CA7S), in the GI tract of both mice and humans after sleeve gastrectomy. We show that CA7S is a Takeda G-protein receptor 5 (TGR5) agonist that increases Tgr5 expression and induces GLP-1 secretion. Furthermore, CA7S administration increases glucose tolerance in insulin-resistant mice in a TGR5-dependent manner. CA7S remains gut restricted, minimizing off-target effects previously observed for TGR5 agonists absorbed into the circulation. By studying changes in individual metabolites after surgery, the present study has revealed a naturally occurring TGR5 agonist that exerts systemic glucoregulatory effects while remaining confined to the gut.

Few randomized trials have compared surgical versus lifestyle and pharmacologic approaches for type 2 diabetes (T2D) patients with mild to moderate obesity.This study examined resolution of hyperglycemia (A1C6.5% and fasting glucose126 mg/dL) 3 years after randomization to either a laparoscopic adjustable gastric band (LAGB) or 1-year diabetes and weight management (DWM) program.University medical center, United States.Forty T2D patients (mean ± SD: age, 51.3 ±10.0 yr; weight 109.5 ± 15.0 kg; body mass index [BMI] 36.5 ± 3.7 kg/mAt 3 years, 13% of 16 patients in LAGB and 5% of 17 patients in DWM achieved resolution of hyperglycemia (P = .601), with a modestly greater reduction in antidiabetic medications in the surgical group (P = .054). Reductions from baseline in A1C were sustained at 3 years in LAGB (-.82% [95% CI: -1.62 to -.01], P = .046) compared with DWM (+.23% [95% CI: -.57 to 1.03], P = .567). The surgical group had greater weight loss (-12.0 kg [95% CI: -15.9 to -8.1] versus -4.8 [95% CI: -8.6 to -.9], P = .010). HDL-cholesterol increased more after surgery (P = .003), but changes in triglycerides, LDL-cholesterol, and blood pressure did not differ between treatments. Diabetes- and obesity-specific quality of life improved comparably with both therapies.Achievement of American Diabetes Association targets for glucose, lipids, and blood pressure was similar with both treatment strategies. LAGB leads to greater sustained weight loss and higher HDL cholesterol compared with a DWM program. These findings may help guide patients with T2D and obesity when exploring options for diabetes and weight management.

There is limited Level-1 evidence from well-powered randomized controlled trials (RCTs) examining improved glycemic control after metabolic surgery in patients with type 2 diabetes (T2D) and obesity. ARMMS-T2D is a multi-center consortium conducting a follow-up study of 4 merged RCTs in 256 patients with baseline Class 1-3 obesity and T2D, randomly assigned to metabolic surgery (MS;Roux-en-Y gastric bypass, sleeve gastrectomy, or gastric banding) or intensive Medical/Lifestyle Intervention (MLI). Three years after randomization, T2D remission rates were higher after MS than MLI (37.5%, 60/160 vs. 2.6%, 2/76, respectively, P

Author(s): Reuben, David B; Gill, Thomas M; Stevens, Alan; Williamson, Jeff; Volpi, Elena; Lichtenstein, Maya; Jennings, Lee A; Tan, Zaldy; Evertson, Leslie; Bass, David; Weitzman, Lisa; Carnie, Martie; Wilson, Nancy; Araujo, Katy; Charpentier, Peter; Meng, Can; Greene, Erich J; Dziura, James; Liu, Jodi; Unger, Erin; Yang, Mia; Currie, Katherine; Lenoir, Kristin M; Green, Aval-NaʼRee S; Abraham, Sitara; Vernon, Ashley; Samper-Ternent, Rafael; Raji, Mukaila; Hirst, Roxana M; Galloway, Rebecca; Finney, Glen R; Ladd, Ilene; Rahm, Alanna Kulchak; Borek, Pamela; Peduzzi, Peter | Abstract: Background/objectivesAlthough several approaches have been developed to provide comprehensive care for persons living with dementia (PWD) and their family or friend caregivers, the relative effectiveness and cost effectiveness of community-based dementia care (CBDC) versus health system-based dementia care (CBDC) and the effectiveness of both approaches compared with usual care (UC) are unknown.DesignPragmatic randomized three-arm superiority trial. The unit of randomization is the PWD/caregiver dyad.SettingFour clinical trial sites (CTSs) based in academic and clinical health systems.ParticipantsA total of 2,150 English- or Spanish-speaking PWD who are not receiving hospice or residing in a nursing home and their caregivers.InterventionsEighteen months of (1) HSDC provided by a nurse practitioner or physician's assistant dementia care specialist who works within the health system, or (2) CBDC provided by a social worker or nurse care consultant who works at a community-based organization, or (3) UC with as needed referral to the Alzheimer's Association Helpline.MeasurementsPrimary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales.Secondary outcomesNPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms. Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, "time spent at home," Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost effectiveness using intervention costs and Medicare claims.ResultsThe results will be reported in the spring of 2024.ConclusionD-CARE will address whether emphasis on clinical support and tighter integration with other medical services has greater benefit than emphasis on social support that is tied more closely to community resources. It will also assess the effectiveness of both interventions compared with UC and will evaluate the cost effectiveness of each intervention.

To improve the power of mediation in high-throughput studies, here we introduce High-throughput mediation analysis (Hitman), which accounts for direction of mediation and applies empirical Bayesian linear modeling. We apply Hitman in a retrospective, exploratory analysis of the SLIMM-T2D clinical trial in which participants with type 2 diabetes were randomized to Roux-en-Y gastric bypass (RYGB) or nonsurgical diabetes/weight management, and fasting plasma proteome and metabolome were assayed up to 3 years. RYGB caused greater improvement in HbA1c, which was mediated by growth hormone receptor (GHR). GHR’s mediation is more significant than clinical mediators, including BMI. GHR decreases at 3 months postoperatively alongside increased insulin-like growth factor binding proteins IGFBP1/BP2; plasma GH increased at 1 year. Experimental validation indicates (1) hepatic GHR expression decreases in post-bariatric rats; (2) GHR knockdown in primary hepatocytes decreases gluconeogenic gene expression and glucose production. Thus, RYGB may induce resistance to diabetogenic effects of GH signaling. Trial Registration: Clinicaltrials.gov NCT01073020., Factors underlying the effects of gastric bypass surgery on glucose homeostasis are incompletely understood. Here the authors developed and applied high-throughput mediation analysis to identify proteome/metabolome mediators of improved glucose homeostasis after to gastric bypass surgery, and report that improved glycemia was mediated by the growth hormone receptor.

Bariatric surgery, the most effective treatment for obesity and type 2 diabetes, is consistently associated with increased levels of the incretin hormone GLP-1 and changes in overall levels of circulating bile acids. The levels of individual bile acids in the GI tract following surgery, however, have remained largely unstudied. Using UPLC-MS-based quantification, we observed an increase in an endogenous bile acid, cholic acid-7-sulfate (CA7S), in the GI tract of both mice and humans after sleeve gastrectomy. We show that CA7S is a TGR5 agonist that induces GLP-1 secretion in vitro and in vivo and that CA7S administration increases glucose tolerance in insulin-resistant mice in a GLP-1 receptor-dependent manner. CA7S remains gut-restricted, minimizing off-target effects previously observed for TGR5 agonists absorbed into circulation. By studying changes in individual metabolites following surgery, this study has revealed a naturally occurring TGR5 agonist that exerts systemic glucoregulatory effects while remaining confined to the gut.

OBJECTIVE To compare the effect of Roux-en-Y gastric bypass (RYGB) surgery versus intensive medical diabetes and weight management (IMWM) on clinical and patient-reported outcomes in obese patients with type 2 diabetes. RESEARCH DESIGN AND METHODS We prospectively randomized 38 obese patients with type 2 diabetes (15 male and 23 female, with mean ± SD weight 104 ± 16 kg, BMI 36.3 ± 3.4 kg/m2, age 52 ± 6 years, and HbA1c 8.5 ± 1.3% [69 ± 14 mmol/mol]) to laparoscopic RYGB (n = 19) or IMWM (n = 19). Changes in weight, HbA1c, cardiovascular risk factors (UKPDS risk engine), and self-reported health status (the 36-Item Short-Form [SF-36] survey, Impact of Weight on Quality of Life [IWQOL] instrument, and Problem Areas in Diabetes Survey [PAID]) were assessed. RESULTS After 3 years, the RYGB group had greater weight loss (mean −24.9 kg [95% CI −29.5, −20.4] vs. −5.2 [−10.3, −0.2]; P < 0.001) and lowering of HbA1c (−1.79% [−2.38, −1.20] vs. −0.39% [−1.06, 0.28] [−19.6 mmol/mol {95% CI −26.0, −13.1} vs. −4.3 {−11.6, 3.1}]; P < 0.001) compared with the IMWM group. Changes in cardiometabolic risk for coronary heart disease and stroke were all more favorable in RYGB versus IMWM (P < 0.05 to P < 0.01). IWQOL improved more after RYGB (P < 0.001), primarily due to subscales of physical function, self-esteem, and work performance. SF-36 and PAID scores improved in both groups, with no difference between treatments. A structural equation model demonstrated that improvement in overall quality of life was more strongly associated with weight loss than with improved HbA1c and was manifest by greater improvements in IWQOL than with either SF-36 or PAID. CONCLUSIONS Three years after randomization to RYGB versus IMWM, surgery produced greater weight loss, lower HbA1c, reduced cardiovascular risk, and improvements in obesity-related quality of life in obese patients with type 2 diabetes.

Background The purpose of this study was to compare effects of Roux-en-Y gastric bypass versus a multidisciplinary, group-based medical diabetes and weight management program on physical fitness and behaviors. Methods Physical behavior and fitness were assessed in participants of the study Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes (SLIMM-T2D) (NCT01073020), a randomized, parallel-group trial conducted at a US academic hospital and diabetes clinic with 18- to 24-month follow-up. Thirty-eight type 2 diabetes patients with hemoglobin A 1c ≥6.5% and body mass index 30-42 kg/m 2 were randomized to Roux-en-Y gastric bypass or the medical program. A 6-minute walk test to evaluate fitness, self-reported physical activity, standardized physical surveys, and cardiometabolic risk assessment were performed at baseline and after intervention. Results Both groups similarly improved 6-minute walk test distance, with greater improvements in oxygen saturation and reduced heart rate after surgery. Self-reported physical activity improved similarly at 18-24 months after interventions, although exercise increased gradually after surgery, whereas early substantial increases in the medical group were not fully sustained. Self-reported total and physical health were similar by Short Form-36 but improved more in the Impact of Weight on Quality of Life survey after surgery. Improvement in cardiovascular risk scores, HbA 1c , and body mass index were greater after surgery. Conclusion In this small, randomized study, both interventions led to therapeutic lifestyle changes and improved objective and self-reported physical fitness. Greater improvements in heart rate, oxygen saturation, and perceived impact of weight on health were seen after surgery, which could be attributable to greater weight loss. The clinical importance of these improvements with greater weight loss warrants further investigation.

Despite a number of evidences on the implementation of multicomponent education and support programs to improve the lives of dementia caregivers, there is still a need to adapt these interventions to various implementation settings and preferences of a new generation of caregivers. In this study, we present the development and usability testing of a dementia caregiver support program, GamePlan4Care (GP4C), an online translation of the Resources for Enhancing Alzheimer’s Caregiver Health II (REACH II) intervention. The goal of the GP4C is to create an online family caregiver support system that would facilitate delivery of an evidence-based skills-training and support for dementia caregivers with the potential of both scalability and sustainability. GP4C includes the full breadth of REACH II education and skill-building materials, delivered within an automated, online platform with integrated support from a Dementia Care Specialist via telephone/video conferencing. Dementia caregivers, community agency staff, and other experts are involved in usability testing to ensure acceptability of this new approach to intervention delivery. The software development is completed and usability testing is currently underway. The feasibility and success of this new modality of intervention delivery will be made possible by an innovative intervention design supported by appropriate technical and content elements. We will also present the strategies employed to adapt the intervention to an online platform capable of supporting caregiver self-directed exposure to therapeutic content, the results of usability testing with approximately 32 caregivers, and feedback from other external stakeholders on the feasibility of this approach.

Molecular mechanisms by which Roux-en-Y gastric bypass (RYGB) improves glycemic control and metabolism in type 2 diabetes (T2D) remain incompletely understood. In the SLIMM-T2D trial, participants with T2D were randomized to RYGB or nonsurgical management and their fasting plasma proteome and metabolome were analyzed for up to 3 years. To identify analytes that mediate improvement in outcomes, we developed a high-throughput mediation analysis method (Hitman), which is significantly more powerful than existing methods. Top-ranking analyte mediators of glycemia improvement were growth hormone receptor and prolylhydroxyproline, which were more significant than any clinical mediator, including BMI. Beta-alanine and Histidine Metabolism (both including CNDP1) were top differentially regulated pathways, and Valine, Leucine and Isoleucine Degradation was also a top differentially-regulated pathway and a top mediator of improvement in insulin resistance. The identified analytes may serve as novel targets for T2D therapy. More broadly, Hitman can identify analyte mediators of outcomes in randomized trials for which high-throughput data are available.

BACKGROUND Ventriculoperitoneal shunting (VPS) is effective for the treatment of normal-pressure hydrocephalus (NPH) and sometimes requires laparoscopic assistance with abdominal insufflation. OBJECTIVE To evaluate the association of abdominal insufflation with opening pressure (OP) in NPH patients undergoing VPS implantation. METHODS Between March 2016 and April 2019, 52 consecutive patients who underwent first-time VPS implantation surgery were retrospectively identified by reviewing electronic health records. OP during the large volume lumbar tap test (OPLP) and VPS implantation surgery (OPSURGERY) were measured in 29 patients. RESULTS Laparoscopic assistance with abdominal insufflation was used in 20 (69%) cases. There were no differences in patient age (P = .589), gender (P = .822), body mass index (P = .289), weight (P = .789), height (P = .542), and OPLP (P = .476) in patients operated with and without laparoscopic assistance. When compared to patients operated without laparoscopic assistance, laparoscopic assistance was associated with a greater rate of OP increase during surgery relative to OPLP (40% vs 100%, P = .002), a greater increase in OPSURGERY relative to OPLP (-0.40 ± 5.38 vs 10.17 ± 5.53 cm H2O, P

Peptic ulcers remain a common pathology found in the USA. With the identification of Helicobacter pylori and nonsteroidal anti-inflammatory drugs (NSAIDs) as major contributing factors in the formation of peptic ulcers, targeted medical management has become much more effective in mitigating severe complications. The widespread use of H2 receptor antagonists (H2RAs), proton pump inhibitors (PPIs), and H. pylori eradicating regimens has significantly decreased the need for surgical intervention. Due in large part to these advancements, there has also been a significant decline in the number of hospitalizations for peptic ulcer disease (PUD) in the USA decreasing from 222,000 to 156,000 (29.9%) from 1993 to 2006.

We conducted the following study to evaluate the safety and efficacy of single-stage conversion of failed laparoscopic adjustable gastric band (LAGB) to laparoscopic Roux-en-Y gastric bypass (LRYGB) as compared to a cohort of primary LRYGB patients. A single-institution, prospectively maintained bariatric database was used to retrospectively identify consecutive patients who underwent single-stage removal of LAGB with concomitant conversion to LRYGB between the years of 2007 and 2013. The study cohort was matched 1:1 for age, gender, body mass index (BMI), and approximate date of operation to patients who underwent primary LRYGB. Primary endpoints were operative time, complication rate, length of hospital stay (LOS), and percent excess BMI lost (%EBMIL) at 24-month follow-up. Ninety-four conversion patients met inclusion criteria. There were no statistically significant differences in the mean LOS (3.1 vs. 3.0 days, p = 0.97) or the major complication rate (3.2 vs. 1.1 %, p = 0.62) at 30 days postoperatively. Likewise, 30-day minor complication rates, including readmission, were similar between groups (7.5 vs. 6.4 %, p = 0.77). The average operative time was significantly longer for conversion compared to primary LRYGB (193.5 vs. 132 min; p

To identify molecular mechanisms contributing to postoperative metabolic improvements after Roux-en-Y gastric bypass (RYGB), we performed comprehensive proteomic analysis of fasting human plasma samples obtained from the SLIMM-T2D longitudinal clinical trial, which randomized obese individuals with T2D to RYGB surgery or a one-year intensive medical diabetes and weight management (DWM) program, and followed them for 3 years. Somalogic proteomic analysis was performed on plasma collected in the fasting state at baseline and during longitudinal follow-up, and proteins differentially abundant in RYGB vs. DWM at each time point were identified. The protein with highest magnitude of differential abundance at 3 years was insulin-like growth factor binding protein 2 (IGFBP2), upregulated by 2.2-fold in RYGB vs. DWM (p=4.37E-06); differences were confirmed by ELISA. IGFBP2 inversely correlated at 3 years with BMI (r=-0.74, p=5.31E-05) and HbA1c (r=-0.68, p=0.00004). Notably, IGFBP2 levels were increased at the first postoperative study visit (10% weight loss) following RYGB or at similar weight loss for the DWM group, suggesting an early weight-independent contribution. IGFBP2 is predominantly expressed in liver and upregulated after RYGB in mice (2.8-fold at 8 weeks, GSE68812). To identify IGFBP2-dependent mechanisms contributing to improved hepatic metabolism, we overexpressed mouse IGFBP2 or control vector in mouse AML12 hepatocytes, achieving a 6-fold increase in IGFPB2 protein. qPCR revealed 15-30% downregulation of lipogenic genes (e.g., Fasn, Srebp1) with a 2-fold increase in expression of genes regulating fatty acid oxidation (e.g., Ppara, Ppargc1a). Analysis of metabolism (Seahorse flux analyzer) revealed increased fatty acid oxidation (3-fold, p In conclusion, increased IGFBP2 expression may contribute to improved hepatic lipid oxidative metabolism, and thus induce systemic metabolic improvement after RYGB surgery. Disclosure Y. Yuchi: None. W. Cai: None. T. Takagi: None. H. Pan: None. J. Dreyfuss: None. K. Foster: None. A.H. Vernon: None. D.C. Simonson: Advisory Panel; Self; GI Windows, Inc.. Stock/Shareholder; Self; GI Windows, Inc.. Stock/Shareholder; Spouse/Partner; Phase V Technologies, Inc. A. Goldfine: Employee; Self; Novartis AG. A. Hoeflich: None. M.E. Patti: Research Support; Self; Janssen Pharmaceuticals, Inc.. Other Relationship; Self; Xeris Pharmaceuticals, Inc.. Research Support; Self; Ethicon US, LLC., Coviden, MedImmune. Other Relationship; Self; Novo Nordisk Inc., XOMA Corporation, AstraZeneca, Nestlé. Research Support; Self; Dexcom, Inc.. Consultant; Self; Eiger BioPharmaceuticals.

Background Retrograde intussusception (RI) at the jejunojejunostomy can occur after Roux-en-Y gastric bypass (RYGB). Although this complication is rare, it has been encountered more frequently as the number of bariatric procedures have increased. Little data is available to assist surgeons with the optimal management of this condition. Our objectives were to identify the risk factors for RI after RYGB and report on outcomes after surgical intervention at a tertiary academic surgical unit. Methods We used our prospective longitudinal institutional bariatric surgical database to identify patients with post-RYGB RI from 1996 to 2011. Results We identified 28 post-RYGB RI cases. The median interval between RYGB and RI was 52 months, and the median percentage of excess weight loss was 75%. Patients presented with acute symptoms in 36% of the cases. All patients underwent surgical exploration, including resection and revision of the jejunojejunostomy (46%) or operative reduction with or without enteropexy (54%). Those undergoing resection had a longer hospital stay but similar 30-day complication rates. At a median follow-up of 9 months, only 1 recurrence was documented. Conclusions RI is a rare and late complication of RYGB and typically occurs after significant weight loss. In the presence of ischemia or nonreducible RI, resection and revision of the jejunojejunostomy is recommended. In less acute patients, laparoscopic management with reduction and/or enteropexy offers a reduced hospital length of stay while maintaining equivalent morbidity and low recurrence compared with resection.

Background We hypothesized that laparoscopic adjustable gastric band (LAGB) placement might result in the development of a hiatal hernia (HH) over time. The objective of our study was to determine whether HHs develop after LAGB in the setting of a university hospital. Methods We retrospectively reviewed all outcomes for consecutive LAGB patients in our institutional, longitudinal prospective bariatric surgical database to identify those patients without evidence of a HH at LAGB placement, who subsequently underwent delayed HH repair. Results From 2005 to 2009, 695 gastric bands were implanted. Twelve patients (1.72%) were identified who had no radiographic or intraoperative evidence of a HH at LAGB placement and who subsequently underwent HH repair at re-exploration. Patients presented 18 ± 10 months after band placement. Of these patients, 75% presented with gastroesophageal reflux disease or food intolerance (50% with gastroesophageal reflux disease alone). Also, 2 presented with acute pain due to band slippage and 1 with chronic pain and vomiting. In 50% of the patients, revision procedures detected the HH at operation despite negative preoperative studies. Conclusion In our series, a significant HH developed in 1.7% of LAGB patients who had no clinically identifiable HH at LAGB placement. Persistent dysphagia after band deflation requires careful inspection of the hiatus during surgical revision, even in the absence of radiologic depiction of HH, and might represent an underlying etiology of LAGB dysfunction. This complication, along with esophageal dilation and annular pouch dilation, might represent a constellation of conditions with a common etiology. From the results of our small series, we raise the question of the existence of chronic backpressure created by LAGB restriction and accounting for these complications.

Abdominal CT (abdCT) scans are frequently ordered for Roux-en-Y gastric bypass (RYGB) patients presenting to the emergency department (ED) with abdominal pain, but often do not reveal intra-abdominal pathology. We aimed to develop an algorithm for rational ordering of abdCTs. We retrospectively reviewed our institution’s RYGB patients presenting acutely with abdominal pain, documenting clinical and laboratory data, and scan results. Associations of clinical parameters to abdCT results were examined for outcome predictors. Of 1643 RYGB patients who had surgery between 2005 and 2015, 355 underwent 387 abdCT scans. Based on abdCT, 48 (12 %) patients required surgery and 86 (22 %) another intervention. No clinical or laboratory parameter predicted imaging results. Imaging decisions for RYGB patients do not appear to be amenable to a simple algorithm, and patient work-up should be based on astute clinical judgment.

Laparoscopic adjustable gastric band (LAGB) has gone through major design modifications to improve clinical endpoints and reduce complications. Little is known, however, about the effects of LAGB size on clinical outcomes, or whether outcomes differ based on gender. We set out to examine the impact of band size on surgical weight loss, reoperations, comorbidity resolution, and compare outcomes within gender.We reviewed our prospectively collected longitudinal bariatric database between 2008 and 2010, and compared patients with BMI 35-50 kg/m(2) who had undergone LAGB with the LAP-BAND® APS to those who had the larger APL. Those patients with initial BMI 50 kg/m(2) were excluded to reduce any possible selection bias which favors larger band use in such subjects.Three hundred ninety-four patients met our inclusion criteria; 230 (58 %) in the APS group and 164 (42 %) in the APL group. Female patients in APS group experienced significantly higher percentage excess body weight loss at 6 months, 1 year, and 2 years in comparison to female patients in APL group (p 0.001 for all time points). In contrast, a reverse pattern was observed for male patients. No significant differences were observed between the groups regarding frequency of band adjustments, complications, or comorbidity resolution.Male patients might benefit from APL bands, in contrast to female patients who appear to experience superior weight loss with the smaller APS bands. This study provides the first set of evidence to facilitate surgical decision making for band size selection and highlights differences between genders.

Background Experts become automated when performing surgery, making it difficult to teach complex procedures to trainees. Cognitive task analysis (CTA) enables experts to articulate operative steps and cognitive decisions in complex procedures such as laparoscopic appendectomy, which can then be used to identify central teaching points. Methods Three local surgeon experts in laparoscopic appendectomy were interviewed using critical decision method-based CTA methodology. Interview transcripts were analyzed, and a cognitive demands table (CDT) was created for each expert. The individual CDTs were reviewed by each expert for completeness and then combined into a master CDT. Percentage agreement on operative steps and decision points was calculated for each expert. The experts then participated in a consensus meeting to review the master CDT. Each surgeon expert was asked to identify in the master CDT the most important teaching objectives for junior-level and senior-level residents. The experts' responses for junior-level and senior-level residents were compared using a χ 2 test. Results The surgeon experts identified 24 operative steps and 27 decision points. Eighteen of the 24 operative steps (75%) were identified by all 3 surgeon experts. The percentage of operative steps identified was high for each surgeon expert (96% for surgeon 1, 79% for surgeon 2, and 83% for surgeon 3). Of the 27 decision points, only 5 (19%) were identified by all 3 surgeon experts. The percentage of decision points identified varied by surgeon expert (78% for surgeon 1, 59% for surgeon 2, and 48% for surgeon 3). When asked to identify key teaching points, the surgeon experts were more likely to identify operative steps for junior residents (9 operative steps and 6 decision points) and decision points for senior residents (4 operative steps and 13 decision points) ( P Conclusions CTA can deconstruct the essential operative steps and decision points associated with performing a laparoscopic appendectomy. These results provide a framework to identify key teaching principles to guide intraoperative instruction. These learning objectives could be used to guide resident level–appropriate teaching of an essential general surgery procedure.

Roux-en-Y gastric bypass (RYGB) leads to high-turnover bone loss, but little is known about skeletal effects of laparoscopic adjustable gastric banding (LAGB) or mechanisms underlying bone loss after bariatric surgery.To evaluate effects of RYGB and LAGB on fasting and postprandial indices of bone remodeling.Ancillary investigation of a prospective study at 2 academic institutions.Obese adults aged 21-65 years with type 2 diabetes who underwent RYGB (n = 11) or LAGB (n = 8).Serum C-terminal telopeptide (CTX), procollagen type 1 N-terminal propeptide (P1NP), and PTH were measured during a mixed meal tolerance test at baseline, 10 days and 1 year after surgery. Changes in 25-hydroxyvitamin D, polypeptide YY (PYY), glucagon-like peptide-1, glucose-dependent insulinotropic peptide, and insulin were also assessed.Fasting CTX increased 10 days after RYGB but not LAGB (+69 ± 23% vs +12±12%, P.001), despite comparable weight loss at that time. By 1 year, fasting CTX and P1NP increased more after RYGB than LAGB (CTX +221 ± 60% vs +15 ± 6%, P0.001; P1NP +93 ± 25% vs -9 ± 10%, P.001) and weight loss was greater with RYGB. Changes in CTX were independent of PTH and 25-hydroxyvitamin D but were associated with increases in fasting PYY. Postprandial suppression of CTX was more pronounced after RYGB than LAGB at 10 days and 1 year postoperatively.RYGB is accompanied by early increases in fasting indices of bone remodeling, independent of weight loss or changes in PTH or 25-hydroxyvitamin D. LAGB did not affect bone markers. PYY and other enterohormonal signals may play a role in RYGB-specific skeletal changes.

The effect of laparoscopic sleeve gastrectomy (LSG) on gastroesophageal reflux disease (GERD) is controversial. Although concomitant hiatal hernia repair (HHR) at the time of LSG is common and advocated by many, there are few data on the outcomes of GERD symptoms in these patients. The aim of this study was to evaluate the effect of concomitant HHR on GERD symptoms in morbidly obese patients undergoing LSG.A single institution, multi-surgeon, prospectively maintained database was examined to identify patients who underwent LSG and concomitant HHR from December 2010 to October 2013. Patient characteristics, operative details, and postoperative outcomes were analyzed. Standardized patient questionnaires administered both pre- and postoperatively were utilized. Primary endpoints included subjective reflux symptoms and the need for antisecretory therapy. Weight loss was considered a secondary endpoint.Fifty-eight patients were identified meeting inclusion criteria (LSG + HHR), with a mean follow-up of 97.5 weeks (range 44-172 weeks). The mean age of the cohort was 49.5 ± 11.2 years, with 74.1 % being female. Mean preoperative BMI was 44.2 ± 6.6 kg/m(2). Preoperative upper gastrointestinal contrast series was performed in all patients and demonstrated a hiatal hernia in 34.5 % of patients and reflux in 15.5 % of patients. Preoperatively, 44.8 % (n = 26) of patients reported subjective symptoms of reflux and/or required daily antisecretory therapy [Corrected]. After LSG + HHR, 34.6 % of symptomatic patients had resolution of their symptoms off therapy while the rest remained symptomatic and required daily antisecretory therapy; 84.4 % of patients that were asymptomatic preoperatively remained asymptomatic after surgery. New onset reflux symptoms requiring daily antisecretory therapy was seen in 15.6 % of patients who were previously asymptomatic. Post surgical weight loss did not correlate with the presence or resolution of reflux symptoms.Based on our data, LSG with concomitant HHR improved GERD symptoms or the need for daily antisecretory therapy only in a third of symptomatic patients. Furthermore, 15.6 % of asymptomatic patients developed de novo GERD symptoms despite a HHR. In patients with a documented hiatal hernia, HHR does not lead to GERD resolution or prevention after LSG, indicating the need for appropriate patient counseling and further study.

Recommendations for surgical, compared with lifestyle and pharmacologically based, approaches for type 2 diabetes (T2D) management remain controversial.The objective was to compare laparoscopic adjustable gastric band (LAGB) to an intensive medical diabetes and weight management (IMWM) program for T2D.This was designed as a prospective, randomized clinical trial.The setting was two Harvard Medical School-affiliated academic institutions. INTERVENTIONS AND PARTICIPANTS: A 12-month randomized trial comparing LAGB (n = 23) vs IMWM (n = 22) in persons aged 21-65 years with body mass index of 30-45 kg/m(2), T2D diagnosed more than 1 year earlier, and glycated hemoglobin (HbA(1c)) ≥ 6.5% on antihyperglycemic medication(s).The proportion meeting the prespecified primary glycemic endpoint, defined as HbA(1c)6.5% and fasting glucose7.0 mmol/L at 12 months, on or off medication.After randomization, five participants did not undergo the surgical intervention. Of the 40 initiating intervention (22 males/18 females; age, 51 ± 10 y; body mass index, 36.5 ± 3.7 kg/m(2); diabetes duration, 9 ± 5 y; HbA(1c), 8.2 ± 1.2%; 40% on insulin), the proportion meeting the primary glycemic endpoint was achieved in 33% of the LAGB patients and 23% of the IMWM patients (P = .457). HbA(1c) reduction was similar between groups at both 3 and 12 months (-1.2 ± 0.3 vs -1.0 ± 0.3%; P = .496). Weight loss was similar at 3 months but greater 12 months after LAGB (-13.5 ± 1.7 vs -8.5 ± 1.6 kg; P = .027). Systolic blood pressure reduction was greater after IMWM than LAGB, whereas changes in diastolic blood pressure, lipids, fitness, and cardiovascular risk scores were similar between groups. Patient-reported health status, assessed using the Short Form-36, Impact of Weight on Quality of Life, and Problem Areas in Diabetes, all improved similarly between groups.LAGB and a multidisciplinary IMWM program have similar 1-year benefits on diabetes control, cardiometabolic risk, and patient satisfaction, which should be considered in the context of other factors, such as personal preference, when selecting treatment options with obese T2D patients. Longer duration studies are important to understand emergent differences.

Background: The benefit of laparoscopy in the treatment of pediatric acute appendicitis continues to be controversial, particularly as it relates to operative time and costs. Methods: We reviewed the charts of 200 children who underwent appendectomy for acute appendicitis concurrently over 35 months at a large teaching children’s hospital. Results: Laparoscopic (n = 106) and open (n = 95) appendectomies were performed. The operative times and postoperative lengths of hospital stay were similar for the two groups. The mean total hospital cost for the laparoscopic group ($5,572) was significantly higher than for the open group ($4,472); (p < 0.01). Conclusions: Notably, the results show similar operative times for laparoscopic and open appendectomy. The cost of laparoscopic appendectomy for acute appendicitis is higher than for the open procedure. This study challenges health care providers to reduce costs and develop new ways to measure beneficial outcomes in a pediatric population that may reveal laparoscopic benefits.

Importance Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus. Objective To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass (RYGB) surgery compared with an intensive diabetes medical and weight management (Weight Achievement and Intensive Treatment [Why WAIT]) program for type 2 diabetes. Design, Setting, and Participants A 1-year pragmatic randomized clinical trial was conducted in an academic medical institution. Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study; their body mass index was 30 to 42 (calculated as weight in kilograms divided by height in meters squared) and hemoglobin A 1c (HbA 1c ) was greater than or equal to 6.5%. All participants were receiving antihyperglycemic medications. Interventions RYGB (n = 19) or Why WAIT (n = 19) including 12 weekly multidisciplinary group lifestyle, medical, and educational sessions with monthly follow-up thereafter. Main Outcomes and Measures Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA 1c less than 6.5%, measures of cardiometabolic health, and patient-reported outcomes. Results At 1 year, the proportion of patients achieving HbA 1c below 6.5% and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT (58% vs 16%, respectively; P = .03). Other outcomes, including HbA 1c , weight, waist circumference, fat mass, lean mass, blood pressure, and triglyceride levels, decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT. Improvement in cardiovascular risk scores was greater in the surgical group. At baseline the participants exhibited moderately low self-reported quality-of-life scores reflected by Short Form-36 total, physical health, and mental health, as well as high Impact of Weight on Quality of Life–Lite and Problem Areas in Diabetes health status scores. At 1 year, improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups. The Impact of Weight on Quality of Life–Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT. Conclusions and Relevance In obese patients with type 2 diabetes, RYGB produces greater weight loss and sustained improvements in HbA 1c and cardiometabolic risk factors compared with medical management, with emergent differences over 1 year. Both treatments improve general quality-of-life measures, but RYGB provides greater improvement in the effect of weight on quality of life. These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger randomized trials are performed. Trial Registration clinicaltrials.gov Identifier:NCT01073020

During Roux-en-Y gastric bypasses (RYGB), some surgeons elect to perform a vagotomy to reduce symptoms of gastro-oesophageal reflux (GER). Routine vagotomy during RYGB may independently affect weight loss and metabolic outcomes following bariatric surgery. We aimed to determine whether vagotomy augments percent excess weight loss in obese patients after RYGB.We examined the effect of vagotomy in 1278 patients undergoing RYGB at our institution from 2003 to 2009. Weight and percent excess weight loss (%EWL) were modelled at three months and annually up to five years using a longitudinal linear mixed model controlling for differences in age, gender, initial body mass index (BMI), ideal body weight, and presence of vagotomy.Vagotomy was performed on 40.3% of our cohort. Vagotomy patients had significantly lower initial BMI (46.4±6.2 vs. 48.3±7.7kg/m(2), p0.001), but there were no other significant differences at baseline. The strongest predictor of %EWL over time was initial BMI, with lower BMI patients exhibiting greater %EWL (p0.001). Age and gender effects were also significant, with younger patients (p0.04) and males (p0.002) attaining greater %EWL. Vagotomy had no effect on %EWL in either simple or multiple regression models.Our series suggest that vagotomy does not augment %EWL when performed with RYGB.

Most children with short bowel syndrome experience spontaneous small bowel adaptation over time. This allows the majority to be weaned from parenteral nutrition. There are, however, some children who cannot be weaned and are potential candidates for techniques to promote intestinal adaptation and intestinal lengthening. Here, surgical therapeutic options are described, literature reviewed, and reported results evaluated. Surgical procedures for children with short bowel syndrome have high complication and failure rates, but in most cases are a less invasive option than intestinal transplantation.

Obesity is commonplace, and surgical treatment usually includes Roux-en-Y gastric bypasses (RYGBs). RYGBs have the most documented side effects including vitamin deficiencies, rebound weight gain, and symptomatic hypoglycemia; fewer series exist describing hypoglycemia following other bariatric operations. We reviewed all patients undergoing laparoscopic adjustable gastric banding (LAGB) at our institution between 2008 and 2012. Three patients were identified to have symptomatic hypoglycemia following LAGB. Mean time from surgery was 33 months (range 14–45 months), and mean weight loss was 32.7 kg (range 15.9–43.1 kg). None of the patients had preexisting diabetes. Therefore, symptomatic hypoglycemia should be investigated irrespective of bariatric operation.

SUMMARY Controversy exists regarding optimal treatment practices for esophageal cancer. Esophagectomy has received focus as one of the index procedures for both hospital and surgical quality despite a relative paucity of controlled trials to define best practices. A survey was created to determine the degree of heterogeneity in the treatment of esophageal cancer among a diverse group of surgeons and to use high-volume (HV) (≥15 cases/year) and low-volume (LV) (

The appropriate management of biliary tract disease during pregnancy is uncertain. Although laparoscopic cholecystectomy can be performed safely during pregnancy, the timing and indications for this surgical intervention have not been firmly established. We constructed a Markov decision analytic model that incorporates maternal well-being and fetal outcome into a choice between nonoperative management (NM) and laparoscopic cholecystectomy (LC) for pregnant women with biliary tract disease (BTD). Our model cycles through weeks of pregnancy for a cohort of 200 gravid women presenting with biliary tract disease in both the first and second trimesters. Weekly state probabilities and utilities for fetal outcome were derived from the literature, while weekly utilities for disease and operative states were estimated in consultation with obstetricians. We cycled the model from 6 to 42 weeks and from 19 to 42 weeks to simulate first and second trimester presentations. Outcomes are expressed in quality pregnancy weeks (QPWs). One QPW is the utility of a normal healthy week of pregnancy. A comprehensive search of the literature yielded a fetal death rate following LC for biliary tract disease of 2.2% and following NM of 7%. Relapse rates were found to be trimester dependent and estimated to be 55%, 55%, and 40% in the first, second, and third trimester, respectively. For a hypothetical cohort of 100 women presenting with biliary tract disease in their first trimester, LC generated 12,800 QPWs compared with 12,400 QPWs for NM, an average gain of 4 QPWs per woman. For the cohort of women entering the model in the second trimester, 11,600 QPWs were accrued by the LC group and 11,400 QPWs by the NM group, an average gain of 2 QPWs per woman. These findings were sensitive only to changes in fetal death rates under the two treatment arms. Laparoscopic cholecystectomy is superior to nonoperative management for pregnant women presenting in the first or second trimester with biliary tract disease.

The role of laparoscopic appendectomy for perforated appendicitis remains controversial. This study aimed to compare laparoscopic and open appendectomy outcomes for children with perforated appendicitis.Over a 36-month period, 111 children with perforated appendicitis were analyzed in a retrospective review. These children were treated with either laparoscopic (n = 59) or open appendectomy. The primary outcome measures were operative time, length of hospital stay, time to adequate oral intake, wound infection, intraabdominal abscess formation, and bowel obstruction.The demographic data, presenting symptoms, preoperative laboratory values, and operative times (laparoscopic group, 61 +/- 3 min; open group, 57 +/- 3 were similar for the two groups (p = 0.3). The time to adequate oral intake was 104 +/- 7 h for the laparoscopic group and 127 +/- 12 h for the open group (p = 0.08). The hospitalization time was 189 +/- 14 h for the laparoscopic group, as compared with 210 +/- 15 h for the open group (p = 0.3). The wound infection rate was 6.8% for the laparoscopic group and 23% for the open group (p0.05). The wounds of another 29% of the patients were left open at the time of surgery. The postoperative intraabdominal abscess formation rate was 13.6% for the laparoscopic group and 15.4% for the open group. One patient in each group experienced bowel obstruction.Laparoscopic appendectomy for the children with perforated appendicitis in this study was associated with a significant decrease in the rate of wound infection. Furthermore, on the average, the children who underwent laparoscopic appendectomy tolerated enteral feedings and were discharged from the hospital approximately 24 h earlier than those who had open appendectomy.

OBJECTIVES: Little consensus exists regarding the endoscopic assessment of the esophagogastric junction after antireflux surgery. The purpose of this report is to characterize the gastroesophageal valve appearance unique to each type of antireflux procedure and to introduce an endoscopic lexicon by which to describe this anatomic region. METHODS: Endoscopic Images were obtained from patients who had undergone any one of the following procedures: Nissen, Collis-Nissen, Toupet, and Dor fundoplicatlons and Hill repair. Images were excluded if patients had any symptoms of heartburn, regurgitation, dysphagia, chest pain, or gas bloat or if they were using antisecretory medication. Seven photographs per operation type were evaluated by experienced surgeons and gastroenterologists tasked with describing defining characteristics of each procedure. RESULTS: Ten valve criteria were developed to uniquely identify and quantify the ideal endoscopic appearance of each procedure. Illustrations were created to clearly depict those traits. CONCLUSIONS: Using 10 gastroesophageal valve criteria, the key components of a successful functional repair of the esophagogastric junction were defined. These criteria can be employed when evaluating upper gastrointestinal complaints after antireflux surgery and may ultimately serve as a dependable outcome measure.

Background Minimally invasive Collis gastroplasty is an established technique for managing the shortened esophagus. The purpose of this report is to describe our new technique, the wedge gastroplasty, and report the short-term outcomes. Methods All patients (n = 143) undergoing laparoscopic fundoplication from May 2000 to March 2001 were assessed intraoperatively for shortened esophagus. After mediastinal dissection, 15 patients with inadequate intraabdominal esophageal length underwent wedge gastroplasty. Preoperative symptoms, operative times, and short-term outcomes were evaluated. Results Mean operative time was 184 ± 36 minutes (range 138 to 258). There was 1 cervical esophageal tear from bougie passage and no other minor or major complications. At 6 weeks, there was more improvement in esophageal symptoms compared with extraesophageal symptoms. Conclusions Wedge gastroplasty is effective in decreasing symptoms in patients with shortened esophagus and takes less time to perform than other gastroplasty techniques. Further study is needed to assess long-term outcomes.

tes (defined as maintenance of glycemia with glycated hemoglobin levels below 7% with the patient receiving no diabetes-related medications) occurs in approximately 77% of patients and resolves or improves in 85%. Dyslipidemias also improve or resolve in 70% to 95% of surgically treated patients and hypertension in 87% to 95%. 2 Together, these short-term effects would predict favorable effects on mortality. Concordantly, longerduration follow-up in the SOS study reveals that, in patients without diabetes at baseline, bariatric surgery reduces incident diabetes by 83%; moreover, considering the entire cohort of obese patients, surgery also lowered cardiovascular event rates by 43%, cancer rates by

Stoma was considered enlarged if 2 cm diameter, and pouch enlarged if 6 cm long or 5 cm wide. Results: 275 patients underwent UE and gastric pouch and stoma measurement. Among these were 205 patients (Group 1; 86% female) who had poor weight loss ( 50% EWL) or weight regain post RYGB, and 70 patients (Group 2; 88% female) who had successful weight loss ( 50%EWL), at a mean postoperative time of 6.3 years ( 3.6). Pouch and stoma size were both normal in only 29% of group 1, compared to 43% of group 2 (p 0.03). In group 1, 42% had an enlarged stoma with normal pouch, compared to 27% of group 2 (p 0.03). An enlarged pouch and normal stoma was found in similar proportions in both groups (21% and 15% respectively, p 0.22). Conclusion: Normal sized pouch and stoma are associated with optimal weight loss after RYGB. Patients who don’t lose or regain weight are likely to have abnormal anatomy, particularly stoma enlargement. Further management strategies in these patients may focus on anatomic revision or reinforcement.

Background: The benefit of laparoscopy in the treatment of pediatric acute appendicitis continues to be controversial, particularly as it relates to operative time and costs. Methods: We reviewed the charts of 200 children who underwent appendectomy for acute appendicitis concurrently over 35 months at a large teaching children's hospital. Results: Laparoscopic (n = 106) and open (n = 95) appendectomies were performed. The operative times and postoperative lengths of hospital stay were similar for the two groups. The mean total hospital cost for the laparoscopic group ($5,572) was significantly higher than for the open group ($4,472); (p < 0.01). Conclusions: Notably, the results show similar operative times for laparoscopic and open appendectomy. The cost of laparoscopic appendectomy for acute appendicitis is higher than for the open procedure. This study challenges health care providers to reduce costs and develop new ways to measure beneficial outcomes in a pediatric population that may reveal laparoscopic benefits.