SurgiCal Obesity Treatment Study (SCOTS): protocol for a national prospective cohort study of patients undergoing bariatric surgery in Scotland.

Introduction The efficacy of bariatric surgery for large-scale, long-term weight loss is well established. However, many questions remain over the continual benefits and cost-effectiveness of that weight loss for overall health, particularly when accounting for potential complications and adverse events of surgery. Health research institutes in the UK and the USA have called for high-quality longitudinal cohort studies of patients undergoing bariatric surgery, assessing outcomes such as surgical complications, mortality, diabetes remission, microvascular complications, cardiovascular events, mental health, cost and healthcare use. Methods and analysis SurgiCal Obesity Treatment Study (SCOTS) is a national, prospective, observational, cohort study of patients undergoing primary bariatric surgical procedures in Scotland. This study aims to recruit 2000 patients and conduct a follow-up for 10 years postbariatric surgery using multiple data collection methods: surgeon-recorded data, electronic health record linkage, and patient-reported outcome measures. Outcomes measured will include: mortality, weight change, diabetes, surgical, cardiovascular, cancer, behavioural, reproductive/urological and nutritional variables. Healthcare utilisation and economic productivity will be collected to inform cost-effectiveness analysis. Ethics and dissemination The study has received a favourable ethical opinion from the West of Scotland Research Ethics committee. All publications arising from this cohort study will be published in open-access peer-reviewed journals. All SCOTS investigators (all members of the research team at every recruiting site) will have the ability to propose research suggestions and potential publications using SCOTS data; a publications committee will approve all requests for use of SCOTS data and propose writing committees and timelines. Lay-person summaries of all research findings will be published simultaneously on the SCOTS website (http://www.scotsurgeystudy.org.uk)

Course of Depressive Symptoms and Treatment in the Longitudinal Assessment of Bariatric Surgery (LABS-2) Study

Objective To examine changes in depressive symptoms and treatment in the first three years following bariatric surgery. Design and Methods The Longitudinal Assessment of Bariatric Surgery-2 is an observational cohort study of adults (n=2,458) who underwent a bariatric surgical procedure at one of ten US hospitals between 2006–9. This study includes 2,148 participants who completed the Beck Depression Inventory (BDI) at baseline and ≥ one follow-up visit in years 1–3. Results At baseline, 40.4% self-reported treatment for depression. At least mild depressive symptoms (BDI score≥10) were reported by 28.3%; moderate (BDI score 19–29) and severe (BDI score ≥30) symptoms were uncommon (4.2% and 0.5%, respectively). Mild-to-severe depressive symptoms independently increased the odds (OR=1.75; p=.03) of a major adverse event within 30 days of surgery. Compared with baseline, symptom severity was significantly lower at all follow-up time points (e.g., mild-to-severe symptomatology was 8.9%, 6 months; 8.4%, 1yr; 12.2%, 2yrs; 15.6%, 3yrs; ps<.001), but increased between 1 and 3 years postoperatively (p<.01). Change in depressive symptoms was significantly related to change in body mass index (r=.42; p<0001). Conclusion Bariatric surgery has a positive impact on depressive features. However, data suggest some deterioration in improvement after the first postoperative year

Physical Activity Levels of Patients Undergoing Bariatric Surgery in the Longitudinal Assessment of Bariatric Surgery (LABS) Study

Background- Bariatric surgery candidates' physical activity (PA) level may contribute to the variability of weight loss and body composition changes following bariatric surgery. However, there is little research describing the PA of patients undergoing bariatric surgery to inform PA recommendations in preparation for, and following, surgery. Objectives- Describe PA assessment in the LABS-2 study and report pre-surgery PA level. Examine relationships between objectively determined PA level and 1) BMI and 2) self-reported purposeful exercise. Setting- Six sites in the U.S. Methods- Participants wore an accelerometer and completed a PA diary. Standardized measures of height and weight were obtained. Results- Of 757 participants, 20% were sedentary (<5000 steps/day), 34% low active (5000-7499 steps/day), 27% somewhat active (7500-9999 steps/day), 14% active (10000-12499 steps/day), and 6% were highly active (greater than or equal to 12500 steps/day). BMI was inversely related to mean steps/day and mean steps/minute during the most active 30 minutes each day. The most commonly reported activities were walking, 44%; gardening, 11%; playing with children, 10%; and stretching, 7%. Self-report of minutes of exercise accounted for 2% of the variance in objectively determined steps. Conclusion- Patients present for bariatric surgery with a wide range of PA levels, with almost half categorized as somewhat active or active. BMI is inversely related to total amount and intensity of PA. Few patients report a regular pre-operative exercise regimen suggesting most PA is accumulated from activities of daily living. Patient report of daily minutes of walking or exercise may not be a reliable indication of their PA level. Originally published Surgery for Obesity and Related Diseases, Vol. 4, No. 6, Nov-Dec 200

Physical Exercise following bariatric surgery in women with Morbid obesity Study protocol clinical trial (SPIRIT compliant)

Background: Severe and morbid obesity are increasing globally, particularly in women. As BMI increases, the likelihood of anovulation is higher. The primary aim of the EMOVAR clinical trial is to examine, over the short (16 weeks) and medium (12 months) term, the effects of a supervised physical exercise program (focused primarily on aerobic and resistance training) on ovarian function in women with severe/morbid obesity who have undergone bariatric surgery. Secondary objectives are to examine the effects of the intervention on chronic inflammation, insulin resistance, arterial stiffness, physical fitness, and health-related quality of life. Methods: This is a randomized controlled trial in which ∼40 female bariatric surgery patients, aged between 18 and 45 years old, will be included. Participants assigned to the experimental group will perform a total of 48 sessions of supervised concurrent (strength and aerobic) training (3sessions/week, 60min/session) spread over 16 weeks. Patients assigned to the control group will receive lifestyle recommendations. Outcomes will be assessed at baseline, week 16 (i.e., after the exercise intervention) and 12 months after surgery. The primary outcome is ovarian function using the Sex-Hormone Binding Globuline, measured in serum. Secondary outcomes are serum levels of anti-mullerian hormone, TSH, T4, FSH, LH, estradiol, prolactine, and free androgen index, as well as oocyte count, the diameters of both ovaries, endometrial thickness, and uterine arterial pulsatility index (obtained from a transvaginal ultrasound), the duration of menstrual bleeding and menstrual cycle duration (obtained by personal interview) and hirsutism (Ferriman Gallwey Scale). Other secondary outcomes include serummarkers of chronic inflammation and insulin resistance (i.e., C-reactive protein, interleukin 6, tumor necrosis factor-alpha, leptin, glomerular sedimentation rate, glucose, insulin and theHOMA-IR), arterial stiffness, systolic, diastolic and mean blood pressure, body composition, and total weight loss. Physical fitness (including cardiorespiratory fitness, muscular strength, and flexibility), health-related quality of life (SF-36 v2) and sexual function (Female Sexual Function Index) will also be measured. Discussion: This study will provide, for the first time, relevant information on the effects of exercise training on ovarian function and underlying mechanisms in severe/morbid obese women following bariatric surgery.This work was supported by Ministerio de Economía y Competitividad (MINECO), Plan Nacional de I+D+i call RETOS 2018 (grant n° RTI2018-093302-A-I00). EM-R was funded by the Spanish Ministry of Science, Innovation and Universities (FPU18/01107) and AH-M by the Gerty Cory pre-doctoral program for deficit areas at the University of Almería

APOLO-Bari, an internet-based program for longitudinal support of bariatric surgery patients: study protocol for a randomized controlled trial

Background: Despite evidence of successful weight loss for bariatric surgery patients, some patients experience considerable weight regain over the long term. Given the strong association between post-surgery health behaviors and outcomes, aftercare intervention to address key behaviors appears to be a reasonable relapse-prevention strategy. As the burden of obesity rates increases in healthcare centers, an internet-based program appears to be a reasonable strategy for supporting bariatric surgery patients in the long term. The primary purpose of the current project is to develop and test the efficacy and perceived utility of APOLO-Bari.Methods/design: This study is a randomized control trial, which will be conducted in two hospital centers in the North of Portugal; it includes a control group receiving treatment as usual and an intervention group receiving the APOLO-Bari program for one year in addition to treatment as usual. A total of 180 male and female participants who underwent bariatric surgery (gastric sleeve or gastric bypass surgery) for 12 to 20 months will be recruited. Both groups will complete a similar set of questionnaires at baseline, every 4 months until the end of the intervention, and at 6 and 12 months follow-up. Assessment includes anthropometric variables and psychological self-report measures. The primary outcome measure will be weight regain measured at the end of treatment, and at 6 and 12 months follow-up. The secondary aims are to test the cost-effectiveness of the intervention and to investigate psychological predictors and trajectories of weight regain. APOLO-Bari was developed to address the weight regain problem in the bariatric population by offering additional guidance to bariatric patients during the postoperative period. The program includes: (a) a psychoeducational cognitive-behavioral-based self-help manual, (b) a weekly feedback messaging system that sends a feedback statement related to information reported by the participant, and (c) interactive chat sessions scheduled witThis research was partially supported by the Fundacao para a Ciencia e a Tecnologia through a European Union COMPETE program grant to Eva Conceicao (IF/01219/2014 and PTDC/MHC-PCL/4974/2012), a doctoral scholarship to Ana Pinto-Bastos (SFRH/BD/104159/2014), a doctoral scholarship to Sofia Ramalho (SFRH/BD/104182/2014), and a postdoctoral scholarship to Ana Rita Vaz (SFRH/BPD/94490/2013), co-financed by FEDER under the PT2020 Partnership Agreement (UID/PSI/01662/2013).info:eu-repo/semantics/publishedVersio

Maternal and perinatal outcomes after bariatric surgery: a spanish multicenter study

The final publication is avaliable at Springer Link[Abstract] Background. Bariatric surgery (BS) has become more frequent among women of child-bearing age. Data regarding the underlying maternal and perinatal risks are scarce. The objective of this nationwide study is to evaluate maternal and perinatal outcomes after BS. Methods. We performed a retrospective observational study of 168 pregnancies in 112 women who underwent BS in 10 tertiary hospitals in Spain over a 15-year period. Maternal and perinatal outcomes, including gestational diabetes mellitus (GDM), pregnancy-associated hypertensive disorders (PAHD), pre-term birth cesarean deliveries, small and large for gestational age births (SGA, LGA), still births, and neonatal deaths, were evaluated. Results were further compared according to the type of BS performed: restrictive techniques (vertical-banded gastroplasty, sleeve gastrectomy, and gastric banding), Roux-en-Y gastric bypass (RYGB), and biliopancreatic diversion (BPD). Results. GDM occurred in five (3 %) pregnancies and there were no cases of PAHD. Women whose pregnancies occurred before 1 year after BS had a higher pre-gestational body mass index (BMI) than those who got pregnant 1 year after BS (34.6 ± 7.7 vs 30.4 ± 5.3 kg/m2, p = 0.007). In pregnancies occurring during the first year after BS, a higher rate of stillbirths was observed compared to pregnancies occurring after this period of time (35.5 vs 16.8 %, p = 0.03). Women who underwent BPD delivered a higher rate of SGA babies than women with RYGB or restrictive procedures (34.8, 12.7, and 8.3 %, respectively). Conclusions. Pregnancy should be scheduled at least 1 year after BS. Malabsorptive procedures are associated to a higher rate of SGA births