Changes in Oesophageal Transit, Macro-Reflux Events, and Gastric Emptying Correlate with Improvements in Gastro-Intestinal Symptoms and Food Tolerance Early Post Sleeve Gastrectomy.

PURPOSE: There are significant alterations in gastro-intestinal function, food tolerance, and symptoms following sleeve gastrectomy (SG). These substantially change over the first year, but it is unclear what the underlying physiological basis for these changes is. We examined changes in oesophageal transit and gastric emptying and how these correlate with changes in gastro-intestinal symptoms and food tolerance. MATERIAL AND METHODS: Post-SG patients undertook protocolised nuclear scintigraphy imaging along with a clinical questionnaire at 6 weeks, 6 months, and 12 months. RESULTS: Thirteen patients were studied: mean age (44.8 ± 8.5 years), 76.9% females, pre-operative BMI (46.9 ± 6.7 kg/m2). Post-operative %TWL was 11.9 ± 5.1% (6 weeks) and 32.2 ± 10.1% (12 months), p-value < 0.0001. There was a substantial increase of meal within the proximal stomach; 22.3% (IQR 12%) (6 weeks) vs. 34.2% (IQR 19.7%) (12 months), p = 0.038. Hyper-accelerated transit into the small bowel decreased from 6 weeks 49.6% (IQR 10.8%) to 42.7% (IQR 20.5%) 12 months, p = 0.022. Gastric emptying half-time increased from 6 weeks 19 (IQR 8.5) to 12 months 27 (IQR 11.5) min, p = 0.027. The incidence of deglutitive reflux of semi-solids decreased over time; 46.2% (6 weeks) vs. 18.2% (12 months), p-value < 0.0001. Reflux score of 10.6 ± 7.6 at 6 weeks vs. 3.5 ± 4.4 at 12 months, (p = 0.049) and regurgitation score of 9.9 ± 3.3 at 6 weeks vs. 6.5 ± 1.7, p = 0.021 significantly reduced. CONCLUSIONS: These data demonstrate that there is an increase in the capacity of the proximal gastric sleeve to accommodate substrate over the first year. Gastric emptying remains rapid but reduce over time, correlating with improved food tolerance and reduced reflux symptoms. This is likely the physiological basis for the changes in symptoms and food tolerance observed early post-SG.

Long-term impact of weight loss for people with overweight but not obesity, and with type 2 diabetes: 10-year outcomes of a randomized trial of gastric band surgery.

AIM: Randomized trials reporting 5-year outcomes have shown bariatric surgery  to induce diabetes remission and improve cardiovascular risk. However, the longer-term effects of surgery are uncertain, with only one randomized trial reporting 10-year diabetes outcomes in people with obesity. We aimed to compare 10-year diabetes outcomes of people who are overweight but not obese, randomly assigned to receive either multidisciplinary diabetes care, or multidisciplinary diabetes care combined with gastric band (GB) surgery. METHODS: Between 2009 and 2011, 51 adults were randomized. After 5 years, they were discharged to receive community care and reassessed after 10 years. The primary outcome was diabetes remission, defined as glycated haemoglobin (HbA1c) <6.5% (48 mmol/mol) without glucose-lowering medication. RESULTS: Forty-one participants (20 medical and 21 GB) completed the 10-year assessment. The median (Q1, Q3) weight loss in the GB group was 9.8 (6.7, 16.3)% at 10 years compared with 5.6 (3.4, 7.6)% in the medical group (median difference 4.2%; p = .008). Diabetes remission occurred in five GB participants and no medical participants (relative risk 0.76, 95% CI: 0.55-0.93, p = .048). GB participants used fewer glucose-lowering medications at 10 years but HbA1c, fasting glucose, calculated cardiovascular risk, quality-of-life and incident diabetes complications did not differ significantly between the groups. CONCLUSION: When compared with medical care, GB surgery achieved greater weight loss and modestly increased the likelihood of diabetes remission. However, it did not improve HbA1c, cardiovascular risk or quality of life.

Delayed Gastric Emptying After Sleeve Gastrectomy Is Associated with Poor Weight Loss.

BACKGROUND: Intermediate to long-term weight regain is a major challenge following sleeve gastrectomy (SG). Physiological changes that mediate the extent of weight loss remain unclear. We aimed to determine if there were specific esophago-gastric transit and emptying alterations associated with weight regain. MATERIAL AND METHODS: Participants greater than 12 months post-SG were categorized into optimal (n = 29) and poor weight loss (PWL) (n = 72). All patients underwent a liquid contrast barium swallow demonstrating normal post-surgical anatomy and a protocolized nuclear scintigraphy designed specifically to characterize gastric emptying following SG. RESULTS: The %total weight loss in the optimal group was 26.2 ± 10.5 vs. 14.3 ± 8.8% in the PWL group (p = 0.001). Scintigraphy showed PWL had relatively increased gastric emptying half-time (GE 1/2t) 35 (IQR 23) min vs 19 (IQR 5.5) min (p = 0.001). The multivariate regressions delineated GE 1/2t as the best diagnostic measure for PWL (OR 1.16; CI 1.04-1.29, p-value 0.021). The probability of PWL increased by 16% for every 1-min increase above 21 min of GE 1/2t. A threshold of 21 min was found to have 88% sensitivity and 69% specificity predicting poor weight loss. CONCLUSION: Gastric emptying half-times greater than 21 min appear to reliably correlate with poor weight loss following SG. Additionally, further elevations above 21 min in emptying half-time increase the risk of poor weight loss. We have shown nuclear scintigraphy represents a simple and accurate diagnostic tool in patients who experience poor weight loss after SG, provided substantially altered reporting references in interpreting nuclear scintigraphy are applied.

Comprehensive Analysis of Improvements in Health-Related Quality of Life and Establishment of QALY Gains in a Government-Funded Bariatric Surgical Program with 5-Year Follow-up.

PURPOSE: Bariatric surgery is an efficacious intervention for substantial and sustained weight reduction in individuals with morbid obesity resulting in health improvements. However, the changes to a patient's health related quality of life (HRQoL) in the medium to longer term after bariatric surgery have not been adequately characterized. Our aim was to evaluate the change to patient HRQoL 5 years following bariatric surgery in an Australian government-funded hospital system and determine the significance of relationships between change in physical and mental assessment scores and HRQoL utility scores. MATERIALS AND METHODS: We performed a longitudinal panel study of 81 adult patients who underwent primary bariatric surgery at an Australian tertiary government-funded hospital and completed multi-attribute utility (MAU), multi-attribute non-utility (MA), and disease-specific adjusted quality of life (AQoL) questionnaires before and after bariatric surgery. RESULTS: At a mean (SD) 5.72 (1.07) years postbariatric surgery, participants demonstrated statistically significant improvements in mean AQoL-8D utility (0.135 (0.21); P < 0.0001), yielding a mean 3.2 (1.67) QALYs gained. Beck Depression Inventory-II scores improved (baseline mean 17.35 (9.57); 5-year mean 14.7 (11.57); P = 0.037). Short Form-36 scores improved in the domains of physical functioning and role limitations due to physical health and general health. Change in depression scores and patient satisfaction with surgery were found to be significant predictors of follow up AQoL utility scores. CONCLUSIONS: Bariatric surgery improves physical and psychological quality of life measures over 5 years. The improvement of patient QALYs provide insight to the potential cost utility of publicly funded bariatric surgery in the medium term.

Pathophysiological Mechanisms of Gastro-esophageal Reflux After Sleeve Gastrectomy.

OBJECTIVE: To evaluate the mechanisms associated with reflux events after sleeve gastrectomy (SG). SUMMARY BACKGROUND DATA: Gastro-esophageal reflux (GERD) post-SG is a critical issue due to symptom severity, impact on quality of life, requirement for reoperation, and potential for Barrett esophagus. The pathophysiology is incompletely delineated. METHODS: Post-SG patients, stratified into asymptomatic and symptomatic, underwent protocolized nuclear scintigraphy (n = 83), 24-hour esophageal pH monitoring, and stationary manometry (n = 143) to characterize reflux patterns. Ten patients underwent fasting and postprandial concurrent manometry and pH for detailed analysis of reflux events. RESULTS: Baseline demographics between cohorts were similar: Age 47.2 ± 11.6 versus 44.1 ± 11.3 years ( P = 0.121); females 73.2% versus 90.8% ( P = 0.005); excess weight loss 53.8 ± 28.1% versus 57.4 ± 25.5% ( P = 0.422), follow-up duration 12.3 versus 7.4 months ( P = 0.503). Nuclear scintigraphy delineated bolus-induced deglutitive reflux events (29.6% vs 62.5%, P = 0.005) and postprandial reflux events [4 (IQR2) versus 4 (IQR 3) events, P = 0.356]. Total acid exposure was significantly elevated in the symptomatic population (7.7% vs 3.6%, P < 0.001), especially fasting acid exposure (6.0% vs 1.3%, P < 0.001). pH/manometry analysis demonstrated acute elevations of the gastro-esophageal pressure gradient (>10 mm Hg) underpinned most reflux events. Swallow-induced intragastric hyper-pressur-ization was associated with individual reflux events in most patients (90% in fasting state and 40% postprandial). CONCLUSIONS: We found reflux to be strongly associated with SG and identified 3 unique categories. Bolus-induced deglutitive and postprandial reflux occurred in most patients. Elevated fasting esophageal acid exposure mediated symptoms. Frequent, significant elevation in the gastro-esophageal pressure gradient was the mechanism of reflux and seemed to relate to the noncompliant proximal stomach.

Potential positive effects of bariatric surgery on healthcare resource utilisation.

BACKGROUND: To determine whether a bariatric surgical procedure is associated with a reduction in healthcare utilisation among patients with obesity and high pre-procedural healthcare needs. METHODS: Design: Retrospective cohort study. SETTING: Tertiary Victorian public hospital. PARTICIPANTS: Twenty-nine adults who underwent publicly funded primary bariatric surgery between 2008 and 2018 at the Alfred Hospital, Melbourne and had high resource use over the year prior to surgery, defined as at least two of ≥3 hospital admissions, ≥7 inpatient bed days for obesity-related co-morbidities or inpatient hospital costs ≥$10 000. MAIN OUTCOME MEASURES: Change in inpatient and outpatient resource use. RESULTS: After 1 year following bariatric surgery, total hospital bed days decreased from 663 to 80 and the median (Q1, Q3) per patient decreased from 7 (4.5, 15) to 5 (2.25, 9.75) (p = 0.001) and the total number of hospital admissions fell from 118 to 67 (p < 0.001). The median cost of inpatient care decreased from $11 405 ($4408, $22251) to $3974 ($0, $4325) per annum (p < 0.001). The total and median number of outpatient attendances did not significantly change 12 months after bariatric surgery, but the demand for outpatient services unrelated to bariatric surgery declined by a median of four visits per patient (p = 0.013). CONCLUSIONS: The evidence from this small pilot study suggests that Bariatric surgery has the potential to decrease resource use and inpatient hospital costs over a 1-year time frame for obese patients with high resource use. These data will be used to design a prospective randomised controlled trial to provide more definitive information on this important issue.

Diagnostic Criteria for Gastro-esophageal Reflux Following Sleeve Gastrectomy.

BACKGROUND: Gastro-esophageal reflux disease (GERD) post-sleeve gastrectomy (SG) is a controversial issue and diagnostic dilemma. Strong heterogeneity exists in the assessment of reflux post-SG, and better diagnostic tools are needed to characterize symptomatic reflux. We aimed to determine the discriminant factors of symptomatic reflux and establish diagnostic thresholds for GERD following SG. MATERIALS AND METHODS: Patients post-SG were categorized into asymptomatic and symptomatic cohorts and completed validated symptom questionnaires. All patients underwent stationary esophageal manometry and 24-h ambulatory pH monitoring. Univariate and multivariate analyses were conducted to determine the strongest discriminant factors for GERD. RESULTS: Baseline characteristics of the asymptomatic cohort (n = 48) and symptomatic cohort (n = 76) were comparable. The median post-operative duration was 7.3 (14.1) vs 7.5 (10.7) months (p = 0.825). The symptomatic cohort was more female predominant (90.8 vs 72.9%, p = 0.008). Reflux scores were significantly higher in the symptomatic group (36.0 vs 10.5, p = 0.003). Stationary manometry parameters were similar, including hiatus hernia prevalence and impaired esophageal motility. The symptomatic cohort had significantly higher total acid exposure, especially while supine (11.3% vs 0.6%, p < 0.001). Univariate and multivariate regressions delineated reflux score and supine acid exposure as discriminant factors for symptomatic reflux. The thresholds for distinguishing symptomatic reflux are as follows: reflux score of 11.5 (sensitivity 84.0%, specificity 68.2%) and supine acid exposure of 2.65% (sensitivity 67.1%, specificity 70.8%). CONCLUSION: A reflux score of 11.5 or more or supine acid exposure of 2.65% or more should be considered diagnostic in defining symptomatic reflux following SG.

Gastric Band Surgery Leads to Improved Insulin Secretion in Overweight People with Type 2 Diabetes.

BACKGROUND: We aimed to determine the effects of laparoscopic adjustable gastric band (LAGB) on beta-cell function in overweight people with type 2 diabetes and to assess the relationship between baseline beta-cell function and glycemic outcomes. METHODS: We studied 44 overweight but not obese people with type 2 diabetes who participated in a randomized trial whose primary outcome was the rate of diabetes remission after 2 years of multidisciplinary diabetes care (MDC group) or multidisciplinary care combined with LAGB. Dynamic beta-cell function was assessed by intravenous glucose challenge, and basal beta-cell function (HOMA-B) and insulin sensitivity (HOMA-S) were determined using the homeostatic model. RESULTS: Twelve LAGB participants and two MDC participants were in diabetes remission at 2 years. HOMA-S and the C-peptide response to intravenous glucose increased significantly in LAGB but not in MDC participants. The insulin response to glucose did not change in LAGB participants, whereas their fasting C-peptide/insulin ratio increased. Baseline measures of beta-cell function correlated with diabetes remission but not with reduction in HbA1c following LAGB. CONCLUSIONS: In overweight people with diabetes, LAGB improves endogenous beta-cell function after 2 years. Baseline beta-cell function correlated with diabetes remission, but not with HbA1c change following LAGB.

Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial.

BACKGROUND: Bariatric surgery improves glycaemia in obese people with type 2 diabetes, but its effects are uncertain in overweight people with this disease. We aimed to identify whether laparoscopic adjustable gastric band surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese. METHODS: We did an open-label, parallel-group, randomised controlled trial between Nov 1, 2009, and June 30, 2013, at one centre in Melbourne, Australia. Patients aged 18-65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were randomly assigned (1:1), by computer-generated random sequence, to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone. The primary outcome was diabetes remission 2 years after randomisation, defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose, at least two days after stopping glucose-lowering drugs. Analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000286246. FINDINGS: 51 patients were randomised to the multidisciplinary care plus gastric band group (n=25) or the multidisciplinary care only group (n=26), of whom 23 participants and 25 participants, respectively, completed follow-up to 2 years. 12 (52%) participants in the multidisciplinary care plus gastric band group and two (8%) participants in the multidisciplinary care only group achieved diabetes remission (difference in proportions 0.44, 95% CI 0.17-0.71; p=0.0012). One (4%) participant in the gastric band group needed revisional surgery and four others (17%) had a total of five episodes of food intolerance due to excessive adjustment of the band. INTERPRETATION: When added to multidisciplinary care, laparoscopic adjustable gastric band surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile. Laparoscopic adjustable gastric band surgery is a reasonable treatment option for this population. FUNDING: Monash University Centre for Obesity Research and Education and Allergan.

Laparoscopic adjustable gastric banding and progression from impaired fasting glucose to diabetes.

AIMS/HYPOTHESIS: Obesity and dysglycaemia are major risk factors for type 2 diabetes. We determined if obese people undergoing laparoscopic adjustable gastric banding (LAGB) had a reduced risk of progressing from impaired fasting glucose (IFG) to diabetes. METHODS: This was a retrospective cohort study of obese people with IFG who underwent LAGB. Weight and diabetes outcomes after a minimum follow-up period of 4 years (mean ± SD 6.1 ± 1.7 years) were compared with those of Australian adults with IFG from a population-based study (AusDiab). RESULTS: We identified 281 LAGB patients with baseline IFG. Their mean ± SD age and BMI were 46 ± 9 years and 46 ± 9 kg/m(2), respectively. The diabetes incidence for patients in the lowest, middle and highest weight loss tertile were 19.1, 3.4 and 1.8 cases/1,000 person-years, respectively. The AusDiab cohort had a lower BMI (28 ± 5 kg/m(2)) and a diabetes incidence of 12.5 cases/1,000 person-years. This increased to 20.5 cases/1,000 person-years when analysis was restricted to the 322 obese AusDiab participants, which was higher than the overall rate of 8.2 cases/1,000 person-years seen in the LAGB group (p = 0.02). Multivariable analysis of the combined LAGB and AusDiab data suggested that LAGB was associated with ∼75% lower risk of diabetes (OR 0.24 [95% CI 0.10, 0.57], p = 0.004). CONCLUSIONS/INTERPRETATION: In obese people with IFG, weight loss after LAGB is associated with a substantially reduced risk of progressing to diabetes over ≥4 years. Bariatric surgery may be an effective diabetes prevention strategy in this population.

Perceived discrimination and stigmatisation against severely obese women: age and weight loss make a difference.

AIMS: Patients' perceptions about weight-related stigma and discrimination were assessed in 2 groups of patients, obese and laparoscopic adjustable gastric banding (LAGB). METHODS: Seven focus group sessions were held including a total of 32 women, 8 obese (body mass index 35+) and 24 who had lost 50% of excess weight following bariatric surgery. During the sessions, participants were asked to consider their experiences in situations including general, family, friends, work place, medical, and educational settings. RESULTS: Whilst perceptions of discrimination and stigmatisation were common and affected many life situations, they were less prevalent than previous reports. It appeared that it was not the frequency or number of events which affected an individual but the intensity of the experience. Younger women reported greater discrimination than older women and felt the social consequences of obesity to a greater extent. Older women were more concerned about the consequences of being overweight on their health. CONCLUSIONS: Women who had lost weight considered that aspects of their own behaviours when obese contributed to their experiences of discrimination and stigmatisation. Perceptions of discrimination and stigmatisation appear to be influenced by age and current weight status.

Cost-efficacy of surgically induced weight loss for the management of type 2 diabetes: a randomized controlled trial.

OBJECTIVE: To determine the within-trial cost-efficacy of surgical therapy relative to conventional therapy for achieving remission of recently diagnosed type 2 diabetes in class I and II obese patients. RESEARCH DESIGN AND METHODS: Efficacy results were derived from a 2-year randomized controlled trial. A health sector perspective was adopted, and within-trial intervention costs included gastric banding surgery, mitigation of complications, outpatient medical consultations, medical investigations, pathology, weight loss therapies, and medication. Resource use was measured based on data drawn from a trial database and patient medical records and valued based on private hospital costs and government schedules in 2006 Australian dollars (AUD). An incremental cost-effectiveness analysis was undertaken. RESULTS: Mean 2-year intervention costs per patient were 13,400 AUD for surgical therapy and 3,400 AUD for conventional therapy, with laparoscopic adjustable gastric band (LAGB) surgery accounting for 85% of the difference. Outpatient medical consultation costs were three times higher for surgical patients, whereas medication costs were 1.5 times higher for conventional patients. The cost differences were primarily in the first 6 months of the trial. Relative to conventional therapy, the incremental cost-effectiveness ratio for surgical therapy was 16,600 AUD per case of diabetes remitted (currency exchange: 1 AUD = 0.74 USD). CONCLUSIONS: Surgical therapy appears to be a cost-effective option for managing type 2 diabetes in class I and II obese patients.

Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial.

CONTEXT: Observational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes. OBJECTIVE: To determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than conventional approaches to weight loss and diabetes control. DESIGN, SETTING, AND PARTICIPANTS: Unblinded randomized controlled trial conducted from December 2002 through December 2006 at the University Obesity Research Center in Australia, with general community recruitment to established treatment programs. Participants were 60 obese patients (BMI >30 and <40) with recently diagnosed (<2 years) type 2 diabetes. INTERVENTIONS: Conventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric banding with conventional diabetes care. MAIN OUTCOME MEASURES: Remission of type 2 diabetes (fasting glucose level <126 mg/dL [7.0 mmol/L] and glycated hemoglobin [HbA1c] value <6.2% while taking no glycemic therapy). Secondary measures included weight and components of the metabolic syndrome. Analysis was by intention-to-treat. RESULTS: Of the 60 patients enrolled, 55 (92%) completed the 2-year follow-up. Remission of type 2 diabetes was achieved by 22 (73%) in the surgical group and 4 (13%) in the conventional-therapy group. Relative risk of remission for the surgical group was 5.5 (95% confidence interval, 2.2-14.0). Surgical and conventional-therapy groups lost a mean (SD) of 20.7% (8.6%) and 1.7% (5.2%) of weight, respectively, at 2 years (P < .001). Remission of type 2 diabetes was related to weight loss (R2 = 0.46, P < .001) and lower baseline HbA1c levels (combined R2 = 0.52, P < .001). There were no serious complications in either group. CONCLUSIONS: Participants randomized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss. These results need to be confirmed in a larger, more diverse population and have long-term efficacy assessed. TRIAL REGISTRATION: actr.org Identifier: ACTRN012605000159651.

Preoxygenation is more effective in the 25 degrees head-up position than in the supine position in severely obese patients: a randomized controlled study.

BACKGROUND: Class III obese patients have altered respiratory mechanics, which are further impaired in the supine position. The authors explored the hypothesis that preoxygenation in the 25 degrees head-up position allows a greater safety margin for induction of anesthesia than the supine position. METHODS: A randomized controlled trial measured oxygen saturation and the desaturation safety period after 3 min of preoxygenation in 42 consecutive (male:female 13:29) severely obese (body mass index > 40 kg/m) patients who were undergoing laparoscopic adjustable gastric band surgery and were randomly assigned to the supine position or the 25 degrees head-up position. Serial arterial blood gases were taken before and after preoxygenation and 90 s after induction. After induction, ventilation was delayed until blood oxygen saturation reached 92%, and this desaturation safety period was recorded. RESULTS: The mean body mass indexes for the supine and 25 degrees head-up groups were 47.3 and 44.9 kg/m, respectively (P = 0.18). The group randomly assigned to the 25 degrees head-up position achieved higher preinduction oxygen tensions (442 +/- 104 vs. 360 +/- 99 mmHg; P = 0.012) and took longer to reach an oxygen saturation of 92% (201 +/- 55 vs. 155 +/- 69 s; P = 0.023). There was a strong positive correlation between the induction oxygen tension achieved and the time to reach an oxygen saturation of 92% (r = 0.51, P = 0.001). There were no adverse events associated with the study. CONCLUSION: Preoxygenation in the 25 degrees head-up position achieves 23% higher oxygen tensions, allowing a clinically significant increase in the desaturation safety period--greater time for intubation and airway control. Induction in the 25 degrees head-up position may provide a greater safety margin for airway control.