Obesity impacts physical, physiological and psychological domains of life. The long-term effects of metabolic bariatric surgery (MBS) on patient-centred outcomes such as mental health and quality of life (QOL) may enhance the management of obesity and the application of MBS. A prospective, blinded, double arm, parallel, randomised trial was carried out at a single bariatric centre in Waitemata, New Zealand. Adults with type 2 diabetes mellitus and obesity were randomised 1:1 to undergo laparoscopic sleeve gastrectomy (SG) or silastic ring Roux-en-Y gastric bypass (SR-RYGB). After unblinding at 5 years, patients were followed up at 10 years. This analysis focuses on secondary outcomes: Hospital Anxiety and Depression Scale (HADS) scores and RAND-36 QOL scores. Of 114 patients randomised, 80 patients (70.2

Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are common bariatric procedures that are effective in treating type 2 diabetes (T2D) in patients with obesity. The addition of a silastic-ring (SR) to LRYGB may increase weight loss, reduce weight regain, and improve diabetes remission. Five and seven-year results from a prospective, randomized, parallel, two-arm, clinical trial at North Shore Hospital (Auckland, Aotearoa New Zealand) found that SR-LRYGB was superior to LSG for diabetes remission and weight loss following surgery, with acceptable complication rates. Results on longer-term outcomes are still emerging in the literature. A 10-year analysis was conducted on 114 patients with T2D who underwent SR-LRYGB or LSG. The primary outcome was diabetes remission assessed at 10 years. Secondary outcomes included percentage total body weight loss (

BACKGROUND:Laparoscopic sleeve gastrectomy (LSG) is a potentially refluxogenic operation while Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is regarded as an anti-reflux procedure. The aim of this study is to compare long-term incidence of Barrett's Oesophagus (BO) and gastroesophageal reflux disease (GORD) following LSG and LRYGB. METHODS:Participants of a double-blinded randomized controlled trial comparing banded LRYGB and LSG for remission of type 2 diabetes were contacted to take part. A gastroscopy was performed. Primary outcome was endoscopic and histologic evidence of BO. Secondary outcomes included reflux and regurgitation scores, presence of oesophagitis, proton-pump inhibitor (PPI) usage, Body Mass Index (BMI), and percentage excess weight loss (%EWL). RESULTS:Forty-eight of 109 patients were enrolled into the study (LSG 26 vs. LRYGB 22). Mean follow-up was 7.5 years for the LSG group, and 7.4 years for the RYGB group (P = 0.22). 8 LSG patients had BO while 3 LRYGB patients had BO (30.8%vs13.6%, P = 0.19). There was no significant difference in the mean reflux (8.1 ± 9.4(0-36) vs. 9.3 ± 8.8(0-34), P = 0.47) and regurgitation scores (7.7 ± 6.9(0-22) vs. 11.5 ± 10.5(0-44), P = 0.23) for LSG versus LRYGB patients or between those with and without BO. PPI usage before and after surgery was 6/26 (23.1%) versus 13/26 (50.0%) and 8/22 (36.4%) versus 12/22 (54.5%) for LSG and LRYGB patients respectively. PPI usage in patients with and without BO was 7/11 versus 18/37. EWL was significantly greater (P = 0.0013) in the LRYGB group (74.8 ± 28.1%) compared to LSG group (49.7 ± 18.7%). CONCLUSIONS:Long-term incidence of BO trended towards but was not significantly higher for LSG compared to LRYGB group. We support routine endoscopic surveillance for bariatric patients.

BACKGROUND:The standard of care for gastrojejunal anastomotic stricture following metabolic bariatric bypass surgery is endoscopic balloon dilatation, with revisional surgery as a last line option. The use of lumen-apposing metal stents is expanding to include many gastrointestinal benign and malignant causes in selected cases. They may provide an additional treatment option for post-bypass strictures. METHODS:A single centre, retrospective outcomes analysis was performed over a 3-year period of patients with gastrojejunal anastomotic stricture following metabolic bariatric surgery that was treated with a lumen-apposing metal stent. Primary outcomes assessed were clinical success and perforation. Multiple secondary outcomes were assessed regarding safety and endoscopy use. RESULTS:Of 88 patients that had lumen-apposing metal stents placed, 20 satisfied selection criteria. Eleven patients (55%) had at least one balloon dilatation prior to stent placement. All patients achieved clinical success 20 (100%) with zero perforations. Technical success was achieved in 19 patients (95%). There were four (20%) recurrent strictures, two stent migrations (10%) (with no associated complication), and one in-stent food bolus obstruction (5%). One patient ultimately required surgical revision (5%). Three patients had endoscopy within 30 days of stent removal (15%), and five patients required unplanned endoscopy with the stent in situ (25%). CONCLUSION:Lumen-apposing metal stents within our study show potential as another treatment option for gastrojejunal anastomotic stricture following gastric bypass.

aim: Bariatric surgery is an effective tool for weight loss and for improving weight related co-morbidities. Changes in medication usage after a silastic ring laparoscopic Roux-en-Y gastric bypass (SR-LRYGB) compared with laparoscopic sleeve gastrectomy (LSG) are unknown. methods: This was a single-centre, double-blind, randomised controlled trial. Patients were randomised to either SR-LRYGB or LSG. A medication history was obtained at regular follow-up intervals, and mean numbers of prescribed medications were analysed over 5 years. Poisson regression and generalised estimating equations were used to test for statistically significant changes in usage. results: After eight patients were lost to follow-up, data from 52 patients in each group were available for analysis. There was no difference between the SR-LRYGB or LSG groups in the number of medications prescribed, with the exception of oral glucose-lowering medications, where there was a greater decrease after SR-LRYGB compared to LSG (79% vs 55% respectively) from baseline to 5 years. At 5 years, total medication prescribed was down 10% from pre-operative levels. Prescribed insulin decreased by 72%, and cardiovascular medication decreased by 56% compared to baseline. Prescriptions for analgesia increased by 50%, psychiatric medications by 133% and proton-pump inhibitors by 81%. conclusion: Both SR-LRYGB and LSG reduced requirement for diabetic and cardiovascular medications, but increased requirement for nutritional supplementation, analgesia and psychiatric medications. There was a greater reduction in oral anti-diabetic medication prescriptions following SR-LRYGB compared to LSG, but no other difference in medication usage between surgical groups was found.

BACKGROUND Upper gastrointestinal (GI) signet ring cell carcinomas (SRCC) confer a poor prognosis. The benefit of operative intervention for this patient group is controversial in terms of overall survival. AIM To investigate factors relating to survival in patients with upper GI SRCC. METHODS A retrospective, tertiary, single-centre review of patients who were diagnosed with oesophageal, gastroesophageal junction and gastric SRCC was performed. The primary outcome was to compare mortality of patients who underwent operative management with those who had nonoperative management. Secondary outcomes included assessing the relationship between demographic and histopathological factors, and survival. RESULTS One hundred and thirty-one patients were included. The one-year survival for the operative group was 81% and for the nonoperative group was 19.1%. The five-year survival in the operative group was 28.6% vs 1.5% in the nonoperative group. The difference in overall survival between groups was statistically significant (HR 0.19, 95%CI (0.13-0.30), P < 0.001). There was no difference in survival when adjusting for age, smoking status or gender. On multivariate analysis, patients who underwent surgical management, those with a lower stage of disease, and those with a lower Charlson Comorbidity Index (CCI) had significantly improved survival. CONCLUSION Well-selected patients with upper GI SRCC appear to have reasonable medium-term survival following surgery. Offering surgery to a carefully selected patient group may improve the outcome for this disease.

aims: Obesity is a significant health issue. Te Whatu Ora Waitematā serves a population of 650,000 patients across the North Shore, Waitākere and Rodney areas. The Waitematā bariatric service at North Shore Hospital was introduced in October 2001. The aim of this study was to review the development and impact of the service over the last 20 years, and identify whether equivalent bariatric services could viably be introduced into other hospitals in Aotearoa New Zealand. methods: A retrospective audit was conducted of the 20-year results of the Waitematā bariatric surgical service to identify the impact of technology, teaching and research on service provision. results: Since its inception, the Waitematā bariatric service has launched minimally invasive surgery, multiple operative options and an enhanced recovery after surgery (ERAS) protocol. Approximately 100 cases are performed per year. Of these, 3.4% of patients require admission to the intensive care unit/high dependency unit (ICU/HDU), with an average length of stay (LOS) of 0.66 days. The 1-year mortality rate is 0.39%. Eleven surgical fellows have undergone post-fellowship training with the service, which is a recognised training unit for the post-fellowship AANZGOSA/ANZMOSS programme. conclusions: Bariatric surgery can be performed safely and has good long-term outcomes. The Waitematā bariatric service is dedicated to providing excellent care within the resource constraints of a public healthcare system. The high number of procedures, low requirement for ICU/HDU and low mortality rate suggest that bariatric surgery could be safely performed within a public setting in secondary and regional hospitals across the country.

The nucleotide-binding oligomerization domain (NOD)-like receptor (NLR) protein 3 (NLRP3) inflammasome pathway is believed to mediate chronic inflammation in diabetic retinopathy (DR); however, its impact on the progression of DR remains to be elucidated. Therefore, the primary aim of this pilot study was to determine whether systemic inflammasome biomarkers interleukin (IL)-1β and IL-18 can be used to predict DR progression. DR screening results were analyzed against weight, level of glycated hemoglobin (HbA1c), and plasma levels of inflammasome biomarkers (IL-1β and IL-18), as well as general inflammation markers (C-reactive protein (CRP), IL-6, IL-8, tumor necrosis factor-alpha (TNF-α), and vascular endothelial growth factor (VEGF)) in patients with type 2 diabetes at baseline and 1 year post-bariatric surgery. Cross-sectional analysis demonstrated that weight, HbA1c, CRP, and IL-18 did not correlate with DR severity. The progressed group showed a higher relative change in IL-18 and CRP levels compared to the stable and regressed groups. Furthermore, relative changes in plasma CRP levels correlated with those of IL-18. Although further validation with larger cohorts is necessary, this pilot study supports the hypothesis that systemic inflammasome activation is associated with DR progression.

This study investigated the impact of either Roux-en-Y gastric bypass with silastic ring (SR-RYGB) or sleeve gastrectomy (SG) types of bariatric surgery on psychological health and explored the role of pre-existing depressive symptoms on weight loss. A total of 114 participants with obesity and type 2 diabetes were randomized to receive SR-RYGB or SG at a single centre. Data from the Hospital Anxiety and Depression Scale (HADS), RAND 36-item Health Survey and body weight were collected before surgery and annually for 5 years. Sixteen patients were lost to follow-up at 5 years. Of the 98 patients who completed 5-year psychological follow-up assessments, 13 had mild to severe depressive symptoms (SR-RYGB n = 6, SG n = 7). SR-RYGB and SG resulted in similar psychological health improvement but percent weight loss at 5 years was greater for SR-RYGB by 10.6

Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are common bariatric procedures that are effective in treating type 2 diabetes (T2D) in patients with obesity. Limited data from randomized trials are available comparing longevity of diabetes remission directly between the two procedures beyond 5 years. A prospective, randomized, parallel, two-arm, clinical trial comparing the outcomes of silastic ring (SR)-LRYGB versus LSG was conducted at a single (Auckland, New Zealand) center. Patients and researchers were blinded until the 5-year mark and follow-up after this was unblinded. Eligible patients had T2D of > 6 months duration with a BMI 35––65 kg/m2 and were aged 20–55 years. Randomization was 1:1 to SR-LRYGB and LSG following induction of anesthesia and was stratified by age group, BMI group, ethnicity, diabetes duration, and insulin therapy. The primary outcome was T2D remission, defined as HbA1c < 6

Objective: To determine whether silastic-ring laparoscopic Roux-en-Y gastric bypass (SR-LRYGB) or laparoscopic sleeve gastrectomy (LSG) produces superior diabetes remission at 5 years. Research Design and Methods: In a single-centre double-blind trial, 114 adults with type 2 diabetes and BMI 35-65kg/m2 were randomized to SR-LRYGB or LSG (1:1; stratified by age group, BMI group, ethnicity, diabetes duration and insulin therapy) using a web-based service. Diabetes and other metabolic medications were adjusted according to a prespecified protocol. The primary outcome was diabetes remission assessed at 5 years, defined by HbA1c <6% (42mmol/mol) without glucose-lowering medications. Secondary outcomes included changes in weight, cardiometabolic risk factors, quality of life, and adverse events. Results: Diabetes remission after SR-LRYGB vs LSG occurred in 25/53 (47%) vs 18/55 (33%), adjusted odds ratio 4.5; 95% CI 1.6, 15.5; P=0.009; and 4.2; 95% CI 1.3, 13.4; P=0.015 in the intention-to-treat analysis. Percentage body weight loss was greater after SR-LRYGB than after LSG (absolute difference, 10.7%; 95% CI 7.3, 14.0; P<0.001). Improvements in cardiometabolic risk factors were similar, but high-density lipoprotein cholesterol increased more after SR-LRYGB. Early and late complications were similar in both groups. General health and physical functioning improved after both types of surgery, with greater improvement in physical functioning after SR-LRYGB. People of Māori or Pacific ethnicity (26%) had lower incidence of diabetes remission than those of European or other ethnicities (2/25 vs 41/83, P<0.001). Conclusions: SR-LRYGB provided superior diabetes remission and weight loss compared to LSG at 5 years, with similarly low risk of complications.

Background: Bariatric surgical procedures such as laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are increasingly being utilized to manage type 2 diabetes in those with morbid obesity. It is unclear which procedure is more effective for diabetes remission. Methods: In a prospective, parallel, two-arm, study conducted in a single centre, eligible patients aged 20-55 years, with BMI 35-65kg/m2 and type 2 diabetes of at least 6 months duration were randomized 1:1 to silastic ring (SR)-LRYGB or LSG using random number codes. Patients and assessors remained blinded to treatment allocation until after primary outcome of type 2 diabetes remission was assessed at 5 years, defined by HbA1c <6% (42mmol/mol) without the use of glucose lowering medications. Results: Of the 114 patients randomized, 5 died during the 5 year follow up. Diabetes remission assessed in 108/109 (99%) patients, was achieved by 26/53 (49%) after SR-LRYGB vs. 18/55 (33%) after LSG (adjusted odds ratio 6.8; 95% confidence interval, 2.1 to 22.1, p=0.002). Percentage body weight loss assessed in 99/109 (91%) patients, was also greater after SR-LRYGB than after LSG, (26.9± 8.5% vs. 16.3±8.2%, p<0.0001). Acute, 30-day complication rates were similar in both groups. Late re-intervention rates were higher after SR-LRYGB (20 vs. 12). General health and physical functioning domains improved after both types of surgery, with greater improvements in physical functioning after SR-LRYGB (p<0.01). Conclusions: Among patients with obesity and type 2 diabetes, SR-LRYGB provides greater diabetes remission and weight loss compared to LSG at 5 years. Disclosure R. Murphy: None. R. G. Cutfield: None. M. W. C. Booth: None.

Obesity represents a significant public health problem across the developed world. Bariatric surgery is considered the most effective treatment option for morbidly obese individuals in whom non-surgical weight loss has proved unsuccessful, reflecting large-scale Swedish prospective cohort study data demonstrating superior reductions in related morbidity and all-cause mortality compared with conventional weight loss management.1 The laparoscopic Roux-en-Y gastric bypass (LRYGB) is the bariatric operation associated with a greater proportion of excess weight lost compared to the more popular gastric sleeve based on several large prospective, randomised trials.2-4 Dabigatran is thought to be absorbed in the lower stomach and duodenum based on the relatively rapid time to achieve peak serum levels in the serum.5 This is precisely the absorptive surface excluded from the gastrointestinal (GI) tract by the LRYGB operation. While there is no established therapeutic range, data from the Phase II PETRO study (ClinicalTrials.gov Identifier: NCT01227629) showed a mean (range) peak of 184 (64–443) ng/ml and mean trough of 90 (31–225) ng/ml, both based on 150 mg twice daily dosage.6 In 2017, we opportunistically observed a very low peak serum dabigatran of 11 ng/ml in a 46-year-old woman who had undergone LRYGB surgery for weight loss and management of Type II diabetes. Her preoperative peak level measured 8 months earlier was 160 ng/ml, closely approximating the mean peak observed in the PETRO study. Our patient was safely converted to warfarin without experiencing any clinically apparent breakthrough thrombotic events; however, her case prompted the question of whether her very low dabigatran concentration reflected GI malabsorption due to changes in anatomy following LRYGB surgery. As dabigatran remains the most commonly prescribed direct oral anticoagulant (DOAC) in New Zealand (NZ), we were also concerned that other patients on dabigatran therapy may also have sub-therapeutic concentrations following LRYGB, therefore exposing them to a risk of future thrombotic events. There are limited data on oral anticoagulation following bariatric surgery. Case reports of thromboembolic events following LRYGB-type surgery include cerebral infarcts and a saddle pulmonary embolism.7-9 We carried out a retrospective case series of patients who underwent LRYGB surgery at Auckland City (ACH), Middlemore (MMH) and North Shore (NSH) Hospitals between 1 July 2011 (the date dabigatran was first licensed for use in NZ) and 31 December 2018. Electronic dispensing records of those patients who had undergone LRYGB at each hospital were interrogated to identify those prescribed dabigatran. These patients were asked to attend their local community laboratory and undergo measurement of a peak serum dabigatran concentration, dilute thrombin clotting time (dTCT) and serum creatinine. A peak was defined as the serum concentration between 0·5 and 3 h post-dose, consistent with the PETRO and RE-LY (ClinicalTrials.gov Identifier: NCT00262600) studies.6, 10 The dTCT assay was performed on the STA-R Analyser (Diagnostica Stago, Asi è res sur Seine, France) using citrated patient plasma samples diluted 1:8 in Owren-Koller buffer and mixed with normal plasma, followed by the addition of excess human thrombin reagent (1·5 NIH units thrombin/ml). The time to formation of a fibrin clot was then measured using a viscosity-based detection system. Dabigatran concentrations were calculated from this using a 4-point calibration curve (Hyphen BioMed, Neuvillesur-Oise, France).11 Relevant data of 453 patients who underwent LRYGB surgery across the study period were obtained, comprising 187 at ACH, 149 at NSH and 11 at MMH. Of these, nine were identified as being on dabigatran at the time of study and gave their consent to participate. The results from these nine participants are presented in Table I. The median (range) peak serum dabigatran concentration was 34·6 (10–64) ng/ml and median peak dTCT was 67·5 s. Two patients had additional trough measurements of 17 and 28 ng/ml. The median (range) time from surgery to measurement of dabigatran concentration was 876 (25–2062) days. No clinical thromboembolic events were reported during the study period and no patients were identified to be concurrently taking other medications known to potentially interact with dabigatran. Creatinine, μmol/l These results represent the largest series of serum dabigatran following LRYGB surgery published to date. They demonstrate markedly and consistently reduced concentrations relative to Phase II trial data, with the highest values in our cohort only coinciding with the fifth centile reported in the PETRO dataset. This suggests absorption may either be impaired or delayed in the setting of altered GI tract anatomy following the LRYGB, and raises significant concern regarding the risk of future thromboembolic events, which is supported by the aforementioned case reports. Further work is required to evaluate the exact pharmacokinetic profile of dabigatran in this setting. Limited data on dabigatran absorption following bariatric surgery are available in the literature. A recent case series of DOAC serum concentrations in post-bariatric surgery patients demonstrated dabigatran levels within the normal expected range in two patients who had undergone gastric sleeve procedures. However, unlike the LRGYB, this operation retains the area of the GI tract responsible for dabigatran absorption.12 Additionally, an earlier published review of case reports describing low serum dabigatran concentrations from the World Health Organization (WHO) Global Database of Individual Case Safety Reports ('VigiBase') included two patients who had undergone gastric bypass surgery and one with short gut syndrome, supporting our observations described here. Of note, five of the patients contained in this analysis have since been switched to the alternative DOAC, rivaroxaban, and peak serum concentrations were also obtained on these patients. The median (range) was 174 (80–264) ng/ml, which is comparable to the median (range) of 124·6 (91·4–195·5) ng/ml reported previously in the literature across two Phase IIb trials of this medication.13 Recent international guidance suggests warfarin is the oral anticoagulant of choice after bariatric surgery given its ability to be monitored and dose-adjusted.5 Our present data imply significant caution should be exercised with the use of dabigatran after LRYGB, and obtaining drugs concentrations both before and after surgery to assess for possible malabsorption is strongly advised. Our present results also raise the possibility that rivaroxaban may be an acceptable alternative for patients who prefer the convenience of a DOAC; however, given the very small numbers reported here, further evaluation in this patient group is needed.

Objective: To evaluate diabetes remissionafter bariatric surgery by presence of glutamic acid decarboxylase (GAD)antibody among those with obesity and Type 2 diabetes (T2D). Research Design and Methods: ScreeningGAD was performed in 221 patients with T2D and obesity referred for bariatricsurgery. 9/16 patients with GAD and 112/205 without GAD proceeded with surgery.Diabetes remission and weight loss was compared by GAD presence. Results: GAD titres were 16-91 IU/mL inthe first group. Both groups were similar in age, BMI, diabetes duration,insulin treated proportion, HbA1c and C-peptide (1354 ± 548 vs 1358 ±487pmol/L). At1 and 5 years post-operatively, both groups achieved similar BMI reductionand diabetes remission (67% vs 73%, p=0.71, and 56% vs 57%, p=1.0). Conclusion: Low-titre GAD in patients with T2D and retainedC-peptide, should not be a deterrent for bariatric surgery when the principalaim is diabetes remission.

Inequitable access to bariatric surgery by geographical region has been reported internationally, but comparable data on provision of bariatric surgery have not previously been reported in New Zealand. We examined allocated funding and provision of bariatric surgery amongst different regions in New Zealand in the 2013/14 year, and found that there was large variation in both. This highlights that public funded bariatric surgery needs to take into account population prevalence of morbid obesity to reduce inequities by geographical region.