Frequency of cholelithiasis in need of surgical or endoscopic treatment a decade or more after Roux-en-Y gastric bypass.

BACKGROUND: Symptomatic cholelithiasis requiring treatment is a known side effect after Roux-en-Y gastric bypass (RYGB), but reported rates vary greatly. The objectives for this study were to evaluate the long-term frequency of surgical or endoscopic treatment for symptomatic cholelithiasis 10-15 years after RYGB and its relation to self-reported abdominal pain. METHODS: Observational data from 546 patients who underwent RYGB at public hospitals in Central Norway between March 2003 and December 2009 were analyzed. RESULTS: Median follow-up was 11.5 (range 9.1-16.8) years. Sixty-five (11.9%) patients had undergone cholecystectomy prior to RYGB. Out of the 481 patients with intact gallbladder, 77 (16.0%) patients underwent cholecystectomy and six (1.2%) patients had treatment for choledocholithiasis during the observation period. Median time from RYGB to cholecystectomy or treatment of choledocholithiasis was 51 (range 1-160) and 109 (range 10-151) months, respectively. Female sex was associated with an increased risk of subsequent cholecystectomy [OR (95% CI) 2.88 (1.31-7.15)], p < 0.05. There was a higher frequency of self-reported abdominal pain at follow-up [OR (95% CI) 1.92 (1.25-2.93)] among patients who underwent cholecystectomy before or after RYGB. CONCLUSION: With a median follow-up of more than 11 years after RYGB, one in six patients with an intact gallbladder at time of RYGB underwent cholecystectomy, and 1.1% of the patients needed surgical or endoscopic treatment for choledocholithiasis. Patients with a history of cholecystectomy reported a higher frequency of abdominal pain.

Postbariatric hypoglycemia, abdominal pain and gastrointestinal symptoms after Roux-en-Y gastric bypass explored by continuous glucose monitoring.

BACKGROUND: Abdominal pain and postbariatric hypoglycemia (PBH) are common after bariatric surgery. OBJECTIVES: This study aimed to explore the potential relationship between abdominal pain, gastrointestinal symptoms, and PBH more than a decade after Roux-en-Y gastric bypass (RYGB) and whether continuous glucose monitoring (CGM) with dietary intervention has an educational role in reducing symptoms. SUBJECTS: At two public hospitals in Norway (one University Hospital) 22 of 46 invited patients who reported abdominal pain more than weekly took part. Recruited from a prospective follow-up study of 546 patients 14.5 years after RYGB. METHODS: They used a CGM for two 14-day periods, with a dietary intervention between periods. The Gastrointestinal Symptom Rating Scale (GSRS) and the Dumping Severity Score (DSS) questionnaires were completed at the start and end of the study. RESULTS: The 22 women had preoperative age 39.6 ± 7.7 years and body mass index (BMI) 42.0 ± 4.0 kg/m2, present age 54.6 ± 7.7 years and BMI 29.8 ± 4.8 kg/m2. The total GSRS score and DSS of early dumping decreased after the diet intervention. The number of events with Level 1 (<3.9 mmol/L) or Level 2 (<3.0 mmol/L) hypoglycemia did not change in the second period. Half of the patients had fewer, three had unchanged, and eight had more frequent events with Level 1 hypoglycemia after the intervention. Ten patients had Level 2 hypoglycemia. CONCLUSION: Though inconclusive findings, a personalized dietary intervention reduces GSRS. This intervention was accompanied by lower mean absolute glucose in patients with recurrent abdominal pain after bariatric surgery. However, further studies are needed to explore the benefits of CGM in this setting.

Vitamin and Mineral Deficiency 12 Years After Roux-en-Y Gastric Bypass a Cross-Sectional Multicenter Study.

PURPOSE: Micronutrient deficiencies are common after Roux-en-Y gastric bypass (RYGB). This study explores whether vitamin and mineral deficiency was associated with adherence to recommended supplementation 12 years after RYGB. MATERIALS AND METHODS: The cross-sectional Bariatric Surgery Observation Study (BAROBS) was conducted in 2018-2020 at three hospitals in Central Norway. We report data on 490 patients' self-reported adherence to recommended supplements and vitamin and mineral levels in the blood. The patients, who had RYGB between 2003 and 2009, were recommended an over-the-counter multivitamin-mineral supplement, calcium/vitamin D (1000 mg/20 µg) and vitamin B12 injections (reimbursed), since bariatric supplements were not available then. RESULTS: Mean (SD) age was 40.1 ± 9 years at RYGB, and time to follow-up 11.7 ± 1.6 years. Of 490 patients, 393 (80%) were women. Among 361 (74%) patients' adherent to multivitamin-mineral supplements; folate, vitamin B2, and vitamin B6 deficiency were present in 39 (11%), 103 (29%), and 63 (17%) patients, respectively. The same deficiencies occurred in 44 (34%), 67 (52%), and 67 (52%) patients' non-adherent to recommendations. Although 466 (95%) patients reported adherence to vitamin B12 supplements, sub-optimal levels were found in 73 (16%) patients. Though 336 (69%) patients adhered to calcium/vitamin D supplements (1000 mg/20 µg), sub-optimal vitamin D levels (< 75 nmol/l) were found in 174/336 (52%) adherent patients and 120/154 (78%) non-adherent patients. CONCLUSION: Twelve years after RYGB, adherence to supplements, though in sub-optimal doses of new recommendations, decreases the probability of vitamin and mineral deficiency, especially for thiamine, vitamin B2, vitamin B6, folate, vitamin B12, and vitamin D, but does not eliminate it.

The Long-Term Impact of Postoperative Educational Programs on Weight Loss After Roux-en-Y Gastric Bypass.

PURPOSE: Roux-en-Y gastric bypass (RYGB) is a well-documented treatment of severe obesity. Attending postoperative educational programs may improve the outcome. The aim of this study was to evaluate whether participation in educational programs lasting 2-3 years after RYGB influences long-term weight loss, weight regain, physical activity, and compliance to multivitamin supplements. MATERIALS AND METHODS: The Bariatric Surgery Observation Study (BAROBS) is a multicenter retrospective, cross-sectional study 10-15 years after primary RYGB. Four hundred and ninety-seven participants answered questions regarding participation in postoperative educational programs. Participants were divided into frequent attendees (FA) and infrequent attendees (IFA) at the educational programs. RESULTS: Ten to 15 years after surgery, a total weight loss (TWL) of 23.2 ± 11.6% were seen in the FA group vs 19.5 ± 12.6% in the IFA group, p < 0.001. Percent excess weight loss (%EWL) was 55.7 ± 28.9% vs 46.0 ± 31.1%, p < 0.001. Weight regain in percent of maximal weight loss for the FA was 32.1 ± 32.8% vs IFA 38.4 ± 40.0%, p = 0.052. No difference between the groups in compliance to multivitamin and physical activity. CONCLUSION: Participants with frequent participation in group-based educational programs had better weight loss outcomes 10-15 years after RYGB and tended to have less weight regain. There was no difference between the two groups in participants compliance to recommended multivitamin supplements and physical activity.

Characteristics of Patients Reporting Presumed Problematic Drinking Behavior After Gastric Bypass: Exploring Long-Term Data From the BAROBS Study.

Objective: To explore patients' long-term experiences with drinking alcohol after Roux-n-Y gastric bypass (RYGB) for conceptualizing what may indicate problematic drinking behavior after bariatric surgery. Study Design: Three-center, observational study. Patients: 546 adult patients undergoing RYGB in the period 2003-2009 in Norway. Main Outcome Measures: Self-reported data on drinking behavior and experiences related to alcohol collected 10-15 years after surgery. Results: Out of the 959 patients undergoing RYGB in the period, 29 were diseased and 546 participated in this follow-up study (58.7%). Focusing on suspicious changes in drinking behavior, 8.8% reported drinking more, 11.5% consumed alcohol at least twice a week, and 10.6% consumed at a minimum of 6 units of alcohol at a frequency of at least once monthly. The nature of hangovers had changed for about a third of the patients, with 21.6% reporting these to feel weaker or absent. Repeated alcoholic blackouts were reported by 11.9%. A subgroup of the patients were categorized as displaying presumed problematic drinking behavior(PPDB). Among the PPDB-men there was a significant association to having had a fall last year (6 (100.0%) PPDB-patients vs. 30 (29.7%) non-PPDB, p<.001). Among the PPDB-women, there was a significant association to having had alcohol problems prior to surgery (7 (70.0%) PPDB-patients vs. 67 (17.7%) non-PPDB, p<.001). Less significant associations to PPDB reported for explorative purposes were lack of patient education (men) (16 (26.2%) PPDB-patients vs. 8 (61.5%) non-PPDB, p=.014); more than 3 months persistent musculoskeletal pain (women) (45 (15.3%) PPDB-patients vs. 29 (24.6%) non-PPDB, p=.026); subjective problems with memory (women) (58 (20.7%) PPDB-patients vs. 10 (9.1%) non-PPDB, p=.006); and, receiving professional help for mental problems last 12 months (women) (29 (22.7%) PPDB-patients vs. 45 (14.7%) non-PPDB, p=.043). Conclusion: A subset of patients display drinking behaviors that may be consistent with postsurgical alcohol problems. Screening instruments like AUDIT may not be sufficiently specific to capture several risk behaviors occurring after bariatric surgery.

Iron Deficiency and Anemia 10 Years After Roux-en-Y Gastric Bypass for Severe Obesity.

Iron deficiency with or without anemia is a well-known long-term complication after Roux-en-Y, gastric bypass (RYGB) as the procedure alters the gastrointestinal absorption of iron. Iron is essential for hemoglobin synthesis and a number of cellular processes in muscles, neurons, and other organs. Ferritin is the best marker of iron status, and in a patient without inflammation, iron deficiency occurs when ferritin levels are below 15 µg/L, while iron insufficiency occurs when ferritin levels are below 50 µg/L. Lifelong regular blood tests are recommended after RYGB, but the clinical relevance of iron deficiency and iron insufficiency might be misjudged as long as the hemoglobin levels are normal. The aim of this study was to explore the frequency of iron deficiency and iron deficiency anemia one decade or more after RYGB, the use of per oral iron supplements, and the frequency of intravenous iron treatment. Nine hundred and thirty patients who underwent RYGB for severe obesity at three public hospitals in Norway in the period 2003-2009 were invited to a follow-up visit 10-15 years later. Results from blood tests and survey data on the use of oral iron supplements and intravenous iron treatment were analyzed. Ferritin and hemoglobin levels more than 10 years after RYGB were available on 530 patients [423 (79.8%) women]. Median (IQR) ferritin was 33 (16-63) µg/L, and mean (SD) hemoglobin was 13.4 (1.3) g/dl. Iron deficiency (ferritin ≤ 15 µg/L) was seen in 125 (23.6%) patients; in addition, iron insufficiency (ferritin 16-50 µg/L) occurred in 233 (44%) patients. Mean (SD) hemoglobin levels were 12.5 (1.4) g/dl in patients with iron deficiency, 13.5 (1.2) g/dl in patients with iron insufficiency, 13.8 (1.3) g/dl in the 111 (21%) patients with ferritin 51-100 µg/L, and 13.8 (1.2) g/dl in the 55 (10%) patients with ferritin >100 µg/L. Two hundred and seventy-five (56%) patients reported taking oral iron supplements, and 138 (27.5%) had received intravenous iron treatment after the RYGB procedure. Iron deficiency or iron insufficiency occurred in two-thirds of the patients 10 years after RYGB, although more than half of them reported taking oral iron supplements.

Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial.

INTRODUCTION: The promotion of a healthy diet, physical activity and measurement of blood glucose levels are essential components in the care for women with gestational diabetes mellitus (GDM). Smartphones offer a new way to promote health behaviour. The main aim is to investigate if the use of the Pregnant+ app, in addition to standard care, results in better blood glucose levels compared with current standard care only, for women with GDM. METHODS AND ANALYSIS: This randomised controlled trial will include 230 pregnant women with GDM followed up at 5 outpatient departments (OPD) in the greater Oslo Region. Women with a 2-hour oral glucose tolerance test (OGTT) ≥9 mmol/L, who own a smartphone, understand Norwegian, Urdu or Somali and are <33 weeks pregnant, are invited. The intervention group receives the Pregnant+ app and standard care. The control group receives standard care only. Block randomisation is performed electronically. Data are collected using self-reported questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. Groups will be compared using linear regression for the main outcome and χ2 test for categorical data and Student's t-test or Mann-Whitney-Wilcoxon test for skewed distribution. The main outcome is the glucose level measured at the 2-hour OGTT 3 months postpartum. Secondary outcomes are a change in health behaviour and knowledge about GDM, quality of life, birth weight, mode of delivery and complications for mother and child. ETHICS AND DISSEMINATION: The study is exempt from regional ethics review due to its nature of quality improvement in patient care. Our study has been approved by the Norwegian Social Science Data Services and the patient privacy protections boards governing over the recruitment sites. Findings will be presented in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: NCT02588729, Post-results.

Fluvastatin and lifestyle modification for reduction of carotid intima-media thickness and left ventricular mass progression in drug-treated hypertensives.

OBJECTIVES: The Hypertension High Risk Management trial (HYRIM) investigated the effect of fluvastatin treatment and lifestyle intervention on development of carotid intima-media thickness (IMT) in drug-treated hypertensive patients. METHODS AND RESULTS: HYRIM was a placebo-controlled, 2 x 2 factorial trial in which 568 drug-treated hypertensive men aged 40-74 years with total cholesterol 4.5-8.0 mmol/L, triglycerides <4.5 mmol/L, body mass index 25-35 kg/m2, and a sedentary lifestyle were randomized to receive either fluvastatin, 40 mg daily, or placebo, and either intensive lifestyle intervention (physical activity and diet) or usual care (treatment of hypertension and other disorders by own private physician). Carotid IMT was assessed by B-mode ultrasound vasculography and left ventricular (LV) mass was calculated from ultrasound recordings of the heart. Fluvastatin alone reduced the primary study endpoint of 4-year development of IMT in the common carotid artery (CCA) compared with placebo (p=0.0297). Carotid bulb IMT progression over 4 years was also significantly (p=0.0214) reduced by fluvastatin compared with placebo. Fluvastatin significantly lowered LDL-C levels (mean net difference through 4 years, 0.6 mmol/L; p<0.0001), and reduced the 2-year development of LV mass (p=0.0144) compared with placebo. Lifestyle intervention had no significant effect on LDL-C, carotid IMT or LV mass, and did not increase the effects of fluvastatin. CONCLUSIONS: In drug-treated hypertensive patients in a usual care setting, fluvastatin treatment reduces progression of carotid IMT and LV mass.

Great Health Benefits But No Change in Employment or Psychopharmaceutical Drug Use 2 Years After Roux-en-Y Gastric Bypass.

BACKGROUND: The aim was to examine health benefits and lifestyle factors after Roux-en-Y gastric bypass (RYGB). METHODS: Patients (n = 165) were investigated 2 years after RYGB in relation to psychopharmaceutical drugs, employment status, type 2 diabetes mellitus (T2DM), hypertension, metabolic syndrome (MetS), body weight, physical activity (PA), and energy intake. RESULTS: Excess weight loss (EWL) was 71.4 ± 20.6 %. Prevalence of T2DM, hypertension, and MetS was reduced (P < 0.001 for all). There were no changes in the use of psychopharmaceutical drugs (20.6 vs. 18.8 %, P = 0.549) or in the proportion of unemployed participants (37.7 vs. 33.3 %, P = 0.189) from pre- to post-surgery. Eighty-three percent achieved EWL ≥ 50 %. These subjects had a lower pre-surgery BMI. We found no differences in the prevalence of hypertension, T2DM, and MetS pre-surgery, but the prevalence was lower after surgery compared with subjects with EWL < 50 %. CONCLUSION: RYGB induced remission of T2DM, hypertension, and MetS 2 years after surgery. The benefit was greatest in the group with EWL ≥ 50 %. Despite excellent weight loss, there was no change in the use of psychopharmaceutical drugs or proportion of unemployed participants.