Ten-Year Outcomes Following Roux-en-Y Gastric Bypass vs Duodenal Switch for High Body Mass Index: A Randomized Clinical Trial.

Importance: Results from long-term follow-up after biliopancreatic diversion with duodenal switch (DS) are scarce. Objective: To compare weight loss, health outcomes, and quality of life 10 years or more after Roux-en-Y-gastric bypass (RYGB) and DS surgery in patients with severe obesity-that is, a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 50 to 60. Design, Setting, and Participants: This open-label randomized clinical trial was conducted at 2 academic bariatric centers in Sweden and Norway. Sixty patients with a BMI of 50 to 60 were included from March 1, 2006, to August 31, 2007. Data were analyzed from August 12, 2022, to January 25, 2023. Interventions: Laparoscopic RYGB or laparoscopic DS. Main Outcomes and Measures: The main outcome was change in BMI after 10 or more years. Secondary outcomes included anthropometric measures, lipid and glycemic profiles, bone mass density, adverse events, gastrointestinal tract symptoms, and health-related quality of life. Results: Forty-eight of the original 60 patients (80%) were assessed after a median of 12 (range, 9-13) years (mean [SD] age, 48.0 [6.0] years; 35 women [73%]). At follow-up, the mean BMI reductions were 11.0 (95% CI, 8.3-13.7) for RYGB and 20.3 (95% CI, 17.6-23.0) for DS, with a mean between-group difference of 9.3 (95% CI, 5.4-13.1; P < .001). Total weight loss was 20.0% (95% CI, 15.3%-24.7%) for RYGB and 33.9% (95% CI, 27.8%-40.0%) for DS (P = .001). Mean serum lipid levels, except high-density lipoprotein cholesterol and hemoglobin A1c, improved more in the DS group during follow-up. Bone mass was reduced for both groups from 5 to 10 years, with lower bone mass after DS at 10 years. Quality-of-life scores (Obesity-Related Problem Scale and the 36-Item Short Form Health Survey) were comparable across groups at 10 years. The total number of adverse events was higher after DS (135 vs 97 for RYGB; P = .02). More patients in the DS group developed vitamin deficiencies (21 vs 11 for RYGB; P = .008) including 25-hydroxyvitamin D deficiency (19 for DS vs 9 for RYGB; P = .005). Four of 29 patients in the DS group (14%) developed severe protein-caloric malnutrition, of whom 3 (10%) underwent revisional surgery. Conclusions and Relevance: In this randomized clinical trial, BMI reduction was greater after DS, but RYGB had a better risk profile over 10 years. Biliopancreatic diversion with DS may not be a better surgical strategy than RYGB for patients with a BMI of 50 to 60. Trial Registration: ClinicalTrials.gov Identifier: NCT00327912.

Single anastomosis gastric bypass for morbid obesity. / Gastrisk bypass med én anastomose ved sykelig overvekt.

BACKGROUND: Mini-gastric bypass is a new surgical method for the treatment of morbid obesity. The method was introduced at Oslo University Hospital in 2016. MATERIAL AND METHOD: We performed a retrospective analysis of prospective data collected over a two-year period following mini-gastric bypass between 1 March 2016 and 1 April 2021. RESULTS: Altogether, 241/1611 (15 %) patients who underwent surgery at the Centre for Morbid Obesity in the five-year period received a mini-gastric bypass. A total of 147/241 (61 %) met the inclusion criteria and 125/147 (85 %) were included in the study. Average age was 47.4 years (standard deviation 10.7), and 81/125 (64.8 %) were women. Average weight was 134 (25) kg before and 90 (20) kg after surgery. Total average weight loss two years after surgery was 33.1 % (9.1). Before surgery and two years post-surgery, 20.0 % and 27.2 % had gastroesophageal reflux, 38.3 % and 8.8 % had type II diabetes and 84.8 % and 44.0 % had dyslipidaemia, respectively. Altogether, 12 % developed anaemia, 6.3 % iron deficiency and 23.1 % vitamin D deficiency. Early complications (< 30 days) were recorded in 6/125 (4.8 %) patients and late complications (> 30 days) in 7/125 (5.6 %) patients. The results were comparable to all the quality indicators in the Scandinavian Obesity Surgery Registry Norway. INTERPRETATION: Mini-gastric bypass can be performed with few complications and with a beneficial effect on secondary comorbidity up to two years after surgery.

Pain sensitivity after Roux-en-Y gastric bypass - associations with chronic abdominal pain and psychosocial aspects.

OBJECTIVES: The aims of this study were to investigate modifications in pain sensitivity after RYGB and to explore associations between pain sensitivity and weight loss, chronic abdominal pain, total body pain, anxiety, depression, and pain catastrophizing. METHODS: In total, 163 patients with obesity were examined with a cold pressor test for pain sensitivity before and two years after RYGB. Two aspects of pain sensitivity were registered: Pain intensity (numeric rating scale, range 0-10) and pain tolerance (seconds). Associations between pain sensitivity and the explanatory variables were assessed with linear regression. RESULTS: Two years after RYGB the pain intensity increased (mean ± SD 0.64 ± 1.9 score units, p<0.001). Pain tolerance decreased (7.2 ± 32.4 s, p=0.005). A larger reduction in body mass index was associated with increased pain intensity, ß=-0.090 (95 % CI -0.15 to -0.031, p=0.003), and decreased pain tolerance ß=1.1 (95 % CI 0.95 to 2.2, p=0.03). Before surgery, participants with chronic abdominal pain reported 1.2 ± 0.5 higher pain intensity (p=0.02) and had 19.2 ± 9.3 s lower pain tolerance (p=0.04) than those without abdominal pain. No differences in pain sensitivity were observed between participants who did or did not develop chronic abdominal pain after RYGB. Pain sensitivity was associated with symptoms of anxiety but not with pain catastrophizing, depression or bodily pain. CONCLUSIONS: The pain sensitivity increased after RYGB and was associated with larger weight loss and anxiety symptoms. Changes in pain sensitivity were not associated with development of chronic abdominal pain after RYGB in our study.

Chronic abdominal pain and quality of life after Roux-en-Y gastric bypass and sleeve gastrectomy - a cross-cohort analysis of two prospective longitudinal observational studies.

BACKGROUND: Chronic abdominal pain (CAP) after bariatric surgery is not extensively explored and may impact the postoperative outcomes. OBJECTIVE: To compare the prevalence of patient-reported chronic abdominal pain (CAP) after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). Secondarily, we compared other abdominal and psychological symptoms and quality of life (QoL). Preoperative predictors of postoperative CAP were also explored. SETTING: Tertiary referral centers for bariatric surgery in Norway. METHODS: Analyses of 2 separate prospective longitudinal cohort studies evaluating CAP, abdominal and psychological symptoms and QoL before and 2 years after RYGB and SG. RESULTS: Follow-ups were attended by 416 patients (85.8%), 300/416 (72.1%) were females and 209/416 (50.2%) were RYGB procedures. At follow-up, the mean age was 44.9 (10.0) years, BMI 29.5 (5.4) kg/m2, and total weight loss 31.6 (10.3) %. The prevalence of CAP was 28/236 (11.9%) before and 60/209 (28.7%) after RYGB (P < .001) and 32/223 (14.3%) before and 50/186 (26.9%) after SG (P < .001). Gastrointestinal symptom rating scale scores showed greater deterioration of diarrhea and indigestion after RYGB and reflux after SG. The improvement in depression symptoms was greater after SG, as well as several QoL scores improved more after SG. Patients with CAP after RYGB experienced deterioration in several QoL scores, while these scores improved in patients with CAP after SG. Preoperative hypertension, bothersome reflux symptoms, and CAP predicted postoperative CAP. CONCLUSIONS: The prevalence of CAP increased comparably after RYGB and SG, with worsening of gastroesophageal reflux after SG and greater deterioration of diarrhea and indigestion after RYGB. In patients with CAP at follow-up, several QoL scores improved more after SG than RYGB.

Predicting satisfaction with outcome and follow-up care 5 years after bariatric surgery: A prospective evaluation.

Objective: Patient satisfaction is viewed as essential for a successful outcome of bariatric surgery. Few studies have explored long-term satisfaction prospectively. This study aimed to examine pre- and post-surgery predictors for satisfaction with follow-up care, and change in outcome satisfaction from one to 5 years after bariatric surgery. Methods: A sample of 210 participants was recruited from a single treatment center. Self-reported and medical record data regarding mental and somatic health, body image, follow-up attendance, and weight loss were obtained before, 1 year, and 5 years after surgery. Results: Over 90% of the participants were satisfied with the results and treatment 1 year after surgery, while 69% had their outcome expectations fulfilled and 62% were satisfied with the follow-up 5 years after surgery. A shift from initial satisfaction to unfulfillment of expectations was predicted by baseline body dissatisfaction, greater percentage of weight regain after initial weight loss, and more discomfort from somatic symptoms 5 years after surgery. In addition to symptom discomfort, worry about surgery predicted satisfaction with follow-up care. Conclusion: At 5 years, one-fifth of those initially satisfied reported that bariatric surgery had failed to meet their expectations. This suggests that outcome expectations related to weight loss, somatic symptoms, and body image need to be addressed both before and after bariatric surgery.

A prospective longitudinal study of chronic abdominal pain and symptoms after sleeve gastrectomy.

BACKGROUND: Sleeve gastrectomy (SG) is widely applied. Few studies have evaluated patient-reported abdominal symptoms after SG. OBJECTIVE: To evaluate the prevalence of chronic abdominal pain (CAP) and symptom characteristics after SG. SETTING: Oslo University Hospital and Voss Hospital. METHODS: We performed a longitudinal prospective cohort study of patients operated on with SG at two tertiary referral centers. For broad assessments of abdominal pain and symptoms, consultations were performed and questionnaires retrieved before and 2 years after SG. The definition of CAP or recurrent abdominal pain lasting for more than 3 months was sustained. Preoperative predictors of CAP were explored. RESULTS: Of 249 patients at baseline, 207 (83.1%) had follow-up consultations. Mean preoperative body mass index was 43.9 (6.0) kg/m2, and 181 patients (72.7%) were female. Total weight loss was 31.9% (10.4%). CAP was reported in 32 of 223 patients (14.3%) before and in 50 of 186 patients (26.9%) after SG (P =.002). All mean gastrointestinal symptoms rating scale questionnaire scores increased after SG, and they were higher in patients with CAP. Symptoms of depression decreased but were more prevalent in patients with CAP at follow-up. Most quality-of-life scores increased after SG. However, patients with CAP had lower scores (except for physical functioning). Preoperative bothersome Gastrointestinal Symptom Rating Scale reflux symptoms, study center, and younger age seemed to predict CAP after SG. CONCLUSION: The prevalence of patient-reported CAP increased after SG. Patients reporting CAP had reduced quality-of-life scores.

Bone metabolism, bone mineral density and low-energy fractures 10 years after Roux-en-Y gastric bypass.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is a common surgical procedure for treatment of morbid obesity. RYGB induces considerable and sustained weight loss, and remission of obesity related-comorbidities. While studies have suggested negative effects of RYGB on bone health, long-term data are lacking. We aimed to evaluate the prevalence of aBMD below the expected range for age, osteopenia, osteoporosis and low-energy fractures in a defined patient cohort 10 years after RYGB. Secondly, we wanted to identify factors associated with increased risk of aBMD z-score or t-score of -1.1 or lower 10 years after RYGB. METHODS: Patients undergoing RYGB surgery from June 2004 to December 2006 at the Department of Morbid Obesity and Bariatric Surgery, Oslo University Hospital, a tertiary referral centre for treatment of morbid obesity, were invited to a 10 year follow-up. Follow-up visits included morning fasting blood samples, clinical examination, anthropometric measures and dual energy X-ray absorptiometry (DXA). RESULTS: Out of 194 patients eligible for the study, 124 attended the 10 year follow-up and 122 (63%) were examined with DXA. Mean (SD) age was 50.3 (9.0) years, 118 (97%) were of Caucasian ethnicity, 94 were females (77%), of whom 41 (44%) were postmenopausal. Secondary hyperparathyroidism (SHPT) was noted in 37 participants (31%) and vitamin D deficiency (value below 50 nmol/L) and insufficiency (value below 75 nmol/L) in 40 (33%) and 91 (75%), respectively. Among the 63 participants who were premenopausal females or males 49 years or younger the prevalence of areal bone mineral density (aBMD) in the lower range of normal (z-score -1.1- to -1.9) was 30% (n = 19) and aBMD below the expected range for age (z-score ≤ -2.0) was noted in 8% (n = 5). Among the 59 participants who were postmenopausal females or males 50 years or older, the prevalence of osteopenia (t-score -1.1 to -2.4) was 51% (n = 30) and osteoporosis (t-score ≤ -2.5) was 27% (n = 16). The bone resorption markers CTX-1 and PINP were higher in participants with aBMD z-score or t-score of -1.1 or lower compared to participants with aBMD z-score or t-score of -1.0 or higher. Preoperative hypothyroidism, or higher age, postmenopausal status, BMI < 35 kg/m2, SHPT or higher PINP levels at 10 year follow-up were independently associated with aBMD z-score or t-score of -1.1 or lower 10 years after RYGB. Eighteen participants (15%) reported a clinical low-energy fracture after RYGB. In addition, vertebral fracture assessment by DXA revealed that 10 participants (8%) had experienced at least one moderate to severe morphometric vertebral fracture. CONCLUSION: Ten years after RYGB 27% of postmenopausal females and males 50 years or older were osteoporotic, and 8% of premenopausal females and males 49 years or younger exhibited aBMD below the expected range for age. The prevalence of fragility fractures was high. SHPT, higher age, postmenopausal status or higher PINP levels at 10 years and preoperative hypothyroidism were all independent risk factors for aBMD z-score or t-score of -1.1 or lower 10 years after RYGB.

Bariatric surgery at Oslo University Hospital 2004­14. / Fedmekirurgi ved Oslo universitetssykehus 2004­14.

BACKGROUND: Bariatric surgery has been performed at Oslo University Hospital since 2004. We wished to describe patient characteristics, use of surgical methods and perioperative complications in the period 2004-14. MATERIAL AND METHOD: We performed a retrospective analysis of prospective data collected for the period 2004-14. Complications include events during hospitalisation and up to 6-8 weeks postoperatively. RESULTS: Altogether 2 127 patients underwent surgery for morbid obesity, whereof 1 468 were women. Average age and body mass index were 42 years (range 17-73) and 46.2 kg/m2 (range 26-92). A total of 512 had a body mass index ≥ 50 kg/m2. Obesity-related sequelae were registered in 1 196 patients before surgery. Gastric bypass was performed in 1 966 patients, gastric sleeve resection in 122 (17 of these later underwent duodenal switch) and duodenal switch in 56 patients. All patients were operated laparoscopically, and four procedures were converted to laparotomy. Median hospitalisation time was two days (range 1-78). Complications were registered in 209 patients, 75 of whom had severe complications (grade ≥ IIIb on the Clavien-Dindo classification system). Patients with a body mass index ≥ 50 kg/m2 had a higher incidence of complications (12.5 % vs 8.9 %). Altogether 67 patients underwent further surgery. Six patients died, two of whom more than 30 days after the operation. The incidence of complications was reduced during the period. INTERPRETATION: Bariatric surgery may be performed laparoscopically with a low incidence of complications and short hospitalisation times. A large proportion of the patients who underwent surgery had obesity-related sequalae.

Changes in Bone Marrow Adipose Tissue One Year After Roux-en-Y Gastric Bypass: A Prospective Cohort Study.

Bone marrow adipose tissue (BMAT) has been postulated to mediate skeletal fragility in type 2 diabetes (T2D) and obesity. Roux-en-Y gastric bypass (RYGB) induces a substantial weight loss and resolution of comorbidities. However, the procedure induces increased bone turnover and fracture rates. No previous study has evaluated biopsy-measured BMAT fraction preoperatively and after RYGB. In this study, we aimed to investigate BMAT fraction of the hip in participants with and without T2D preoperatively and 1 year after RYGB and explore factors associated with BMAT change. Patients with morbid obesity scheduled for RYGB were examined preoperatively and 1 year after RYGB. Forty-four participants were included and preoperative examinations were possible in 35. Of these, 33 (94%) met for follow-up, 2 were excluded, and BMAT estimation was not possible in 1. Eighteen (60%) of the participants were females and 11 (37%) had T2D. Preoperative BMAT fraction was positively associated with glycosylated hemoglobin and negatively associated with areal bone mineral density (aBMD). After RYGB, BMAT fraction decreased from 40.4 ± 1.7% to 35.6 ± 12.8%, p = 0.042, or with mean percent change of 10.7% of preoperative BMAT fraction. Change in BMAT fraction was positively associated with change in body mass index (BMI) and total body fat. In females, we observed a mean percent reduction of 22.4 ± 19.6%, whereas in males BMAT increased with a mean percent of 6.8 ± 37.5%, p = 0.009. For males, changes in estradiol were associated with BMAT change; this was not observed for females. In participants with and without T2D, the mean percent BMAT reduction was 5.8 ± 36.9% and 13.5 ± 28.0%, respectively, p = 0.52. We conclude that a high BMAT seems to be associated with lower aBMD and poorer glycemic control in obese subjects. After RYGB, we observed a significant decrease in BMAT. The reduction in BMAT did not differ between participants with and without T2D, but appeared sex specific. © 2019 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals, Inc.

Bone Turnover Markers After Standard and Distal Roux-en-Y Gastric Bypass: Results from a Randomized Controlled Trial.

BACKGROUND: Roux-en-Y gastric bypass is associated with increased risk of bone fractures. Malabsorptive procedures may be associated with secondary hyperparathyroidism and detrimental effects on bone health. We aimed to compare the effects of standard and distal gastric bypass on bone turnover markers 2 years after surgery. METHODS: Patients with body mass index (BMI) 50-60 kg/m2 (n = 113) were randomized to standard or distal gastric bypass, 105 patients (95%) completed 2-year follow-up. Serum C-terminal telopeptide of type I collagen (CTX-1), procollagen type I N-propeptide (PINP), and bone-derived alkaline phosphatase (BALP) was measured at baseline and up to 2 years after surgery. ANCOVA and linear mixed models were used to compare groups. RESULTS: The levels of bone turnover markers increased significantly in both groups, with no statistically significant difference between groups. Two years after standard and distal gastric bypass mean (SD) CTX-1 were 0.81 (0.32) and 0.83 (0.31) µg/L (p = 0.38), mean PINP was 77.6 (23.2) and 77.7 (29.3) µg/L (p = 0.42), and BALP 47.9 (21.9) vs. 50.7 (19.6) µg/L (p = 0.38), respectively. Multiple linear regression analyses showed that PINP and BALP correlated positively (p = 0.01 and p < 0.001) with PTH, but only BALP was significantly higher in patients with secondary hyperparathyroidism (p = 0.001). Type of surgery, vitamin D serum concentrations, and 2-year BMI were all independently associated with PTH levels. CONCLUSION: A comparable increase in bone turnover markers 2 years after standard and distal gastric bypass was observed. There was a higher prevalence of secondary hyperparathyroidism after distal gastric bypass, but this did not impact bone turnover markers. TRIAL REGISTRATION: Clinical Trials.gov number NCT00821197.

Diagnosis and treatment of chronic abdominal pain 5 years after Roux-en-Y gastric bypass.

BACKGROUND: Knowledge of optimal diagnostic workup, etiology, and response to treatment of chronic abdominal pain after Roux-en-Y gastric bypass (RYGB) is limited. OBJECTIVE: To define the etiology of chronic abdominal pain presenting at the 5-year follow-up after RYGB and to evaluate response to treatment. SETTING: Oslo University Hospital (tertiary referral center for obesity surgery). METHODS: Of 234 patients operated during a randomly selected 12-month period, 165 (71%) returned for 5-year follow-up, and 160 responded to study questionnaires. Of these, 54 (34%) reported chronic abdominal pain and were invited to participate in a structured diagnostic and treatment algorithm. These patients were contacted for the evaluation of their response to treatment. RESULTS: Fifty-one of 54 patients (94%) reporting chronic abdominal pain at the 5-year follow-up were included in the study. Of the 45 patients with onset of symptoms post-RYGB, 28 (62%) underwent one or more radiologic evaluations, 10 (22%) underwent endoscopy, and 13 (29%) underwent laparoscopy. Diagnosis and treatment were established for 34 patients (76%), whereas 11 (24%) had abdominal pain of unknown cause. The most common etiology was internal herniation (n = 6), dumping (n = 6), food intolerance (n = 6), gallstones (n = 5), and irritable bowel syndrome (n = 4). After a median follow-up of 13.0 months (standard deviation, 11.5), 37 (82%) patients reported remission or improvement of symptoms, 6 had unchanged symptoms, and 2 patients were lost to follow-up. CONCLUSIONS: The etiology of long-term chronic abdominal pain post-RYGB is diverse. A multidisciplinary team can help most patients with dedicated follow-up, but a subset of patients has symptoms of unknown etiology.

Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial.

BACKGROUND: The preferred surgical procedure for treating morbid obesity is debated. Patient-reported outcome measures (PROMs) are relevant for evaluation of the optimal bariatric procedure. METHODS: A total of 113 patients with BMI from 50 to 60 were randomly assigned to standard (n = 57) or distal (n = 56) Roux-en-Y gastric bypass (RYGB). Validated PROMS questionnaires were completed at baseline and 2 years after surgery. Data were analyzed using mixed models for repeated measures and the results are expressed as estimated means and mean changes. RESULTS: Obesity-related quality of life improved significantly after both procedures, without significant between-group differences (- 0.4 (95% CI = - 8.4, 7.2) points, p = 0.88, ES = 0.06). Both groups had significant reductions in the number of weight-related symptoms and symptom distress score, with a mean group difference (95% CI) of 1.4 (- 0.3, 3.3) symptoms and 5.0 (2.9. 12.8) symptom distress score points. There were no between-group differences for uncontrolled eating (22.0 (17.2-26.7) vs. 28.9 (23.3-34.5) points), cognitive restraint (57.4 (52.0-62.7) vs. 62.1 (57.9-66.2) points), and emotional eating (26.8 (20.5-33.1) vs. 32.6 (25.5-39.7) points). The prevalence of anxiety was 33% after standard and 25% after distal RYGB (p = 0.53), and for depression 12 and 9%, respectively (p = 0.76). CONCLUSIONS: There were no statistically significant differences between standard and distal RYGB 2 years post surgery regarding weight loss, obesity-related quality of life, weight-related symptoms, anxiety, depression, or eating behavior. TRIAL REGISTRATION: Clinical Trials.gov number NCT00821197.

Bile acid profiles over 5 years after gastric bypass and duodenal switch: results from a randomized clinical trial.

BACKGROUND: Bile acids have been proposed as key mediators of the metabolic effects after bariatric surgery. Currently no reports on bile acid profiles after duodenal switch exist, and long-term data after gastric bypass are lacking. OBJECTIVE: To investigate bile acid profiles up to 5 years after Roux-en-Y gastric bypass and biliopancreatic diversion with duodenal switch and to explore the relationship among bile acids and weight loss, lipid profile, and glucose metabolism. SETTINGS: Two Scandinavian University Hospitals. METHODS: We present data from a randomized clinical trial of 60 patients with body mass index 50-60 kg/m2 operated with gastric bypass or duodenal switch. Repeated measurements of total and individual bile acids from fasting serum during 5 years after surgery were performed. RESULTS: Mean concentrations of total bile acids increased from 2.3 µmol/L (95% confidence interval [CI], -.1 to 4.7) at baseline to 5.9 µmol/L (3.5-8.3) 5 years after gastric bypass and from 1.0 µmol/L (95% CI, -1.4 to 3.5) to 9.5 µmol/L (95% CI, 7.1-11.9) after duodenal switch; mean between-group difference was -4.8 µmol/L (95% CI, -9.3 to -.3), P = .036. Mean concentrations of primary bile acids increased more after duodenal switch, whereas secondary bile acids increased proportionally across the groups. Higher levels of total bile acids at 5 years were associated with lower body mass index, greater weight loss, and lower total cholesterol. CONCLUSIONS: Total bile acid concentrations increased substantially over 5 years after both gastric bypass and duodenal switch, with greater increases in total and primary bile acids after duodenal switch. (Surg Obes Relat Dis 2017;0:000-000.) © 2017 American Society for Metabolic and Bariatric Surgery. All rights reserved.

Standard vs Distal Roux-en-Y Gastric Bypass in Patients With Body Mass Index 50 to 60: A Double-blind, Randomized Clinical Trial.

Importance: Up to one-third of patients undergoing bariatric surgery have a body mass index (BMI) of more than 50. Following standard gastric bypass, many of these patients still have a BMI greater than 40 after peak weight loss. Objective: To assess the efficacy and safety of standard gastric bypass vs distal gastric bypass in patients with a BMI of 50 to 60. Design, Setting, and Participants: Double-blind, randomized clinical parallel-group trial at 2 tertiary care centers in Norway (Oslo University Hospital and Vestfold Hospital Trust) between May 2011 and April 2013. The study included 113 patients with a BMI of 50 to 60 aged 20 to 60 years. The 2-year follow-up was completed in May 2015. Interventions: Standard gastric bypass (alimentary limb, 150 cm) and distal gastric bypass (common channel, 150 cm), both with a biliopancreatic limb of 50 cm and a gastric pouch of about 25 mL. Main Outcomes and Measures: Primary outcome was the change in BMI from baseline until 2 years after surgery. Secondary outcomes were cardiometabolic risk factors, nutritional outcomes, adverse events, gastrointestinal symptoms, and health-related quality of life. Results: At baseline, the mean age of the patients was 40 years (95% CI, 38-41 years), 65% were women, mean BMI was 53.5 (95% CI, 52.9-54.0), and mean weight was 158.8 kg (95% CI, 155.3-162.3 kg). The mean reduction in BMI was 17.8 (95% CI, 16.9-18.6) after standard gastric bypass and 17.2 (95% CI, 16.3-18.0) after distal gastric bypass, and the mean between-group difference was 0.6 (95% CI, -0.6 to 1.8; P = .32). Reductions in mean levels of total and low-density lipoprotein cholesterol were greater after distal gastric bypass than standard gastric bypass, and between-group differences were 19 mg/dL (95% CI, 11-27 mg/dL ) and 28 mg/dL (95% CI, 21 to 34 mg/dL), respectively (P < .001 for both). Reductions in fasting glucose levels and hemoglobin A1c were greater after distal gastric bypass. Secondary hyperparathyroidism and loose stools were more frequent after distal gastric bypass. The number of adverse events and changes in health-related quality of life did not differ between the groups. Importantly, 1 patient developed liver failure and 2 patients developed protein-caloric malnutrition treated by elongation of the common channel following distal gastric bypass. Conclusions and Relevance: Distal gastric bypass was not associated with a greater BMI reduction than standard gastric bypass 2 years after surgery. However, we observed different changes in cardiometabolic risk factors and nutritional markers between the groups. Trial Registration: Clinicaltrials.gov Identifier: NCT00821197.

Changes in Health-Related Quality of Life After Gastric Bypass in Patients With and Without Obesity-Related Disease.

BACKGROUND: A substantial proportion of severely obese patients undergoing bariatric surgery have not developed disease as a consequence of obesity. Little is known about the effects of bariatric surgery on health-related quality of life (HRQL) in this patient group. In a prospective study at a public hospital, we compared HRQL in gastric bypass patients with and without obesity-related disease before and 2 years after surgery. METHODS: HRQL was assessed in 232 severely obese patients before, 1 year, and 2 years after Roux-en-Y gastric bypass. We used a general HRQL questionnaire, the Short Form 36, and an obesity-specific questionnaire, the Obesity-related Problems scale. The patients were divided into two groups based on the presence of obesity-related disease (n = 146) or not (n = 86) before surgery. We defined obesity-related disease as having at least one of the following conditions: type 2 diabetes mellitus, hypertension, dyslipidemia, coronary heart disease, obstructive sleep apnea, gastroesophageal reflux disease, or osteoarthritis. Linear mixed models were used to analyze the HRQL outcomes. RESULTS: Before surgery, patients with no obesity-related disease reported equal HRQL compared with patients with obesity-related disease. Two years after gastric bypass, substantial improvements in all subscales of Short Form 36 and in Obesity-related Problems scale were observed in both groups, and the improvements were similar in 7 out of 8 subscales of Short Form 36 as well as for the Obesity-related Problems scale. CONCLUSIONS: Baseline HRQL was similar in patients with and without obesity-related disease prior to gastric bypass. After surgery, patients with no comorbidity had similar positive changes in HRQL as patients with one or several comorbidities. These findings indicate that other factors than obesity-related disease are at least as important for severely obese patients' impaired HRQL.

Five-year outcomes after laparoscopic gastric bypass and laparoscopic duodenal switch in patients with body mass index of 50 to 60: a randomized clinical trial.

IMPORTANCE: There is no consensus as to which bariatric procedure is preferred to reduce weight and improve health in patients with a body mass index higher than 50. OBJECTIVE: To compare 5-year outcomes after Roux-en-Y gastric bypass (gastric bypass) and biliopancreatic diversion with duodenal switch (duodenal switch). DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical open-label trial at Oslo University Hospital, Oslo, Norway, and Sahlgrenska University Hospital, Gothenburg, Sweden. Participants were recruited between March 17, 2006, and August 20, 2007, and included 60 patients aged 20 to 50 years with a body mass index of 50 to 60. The current study provides the 5-year follow-up analyses by intent to treat, excluding one participant accepted for inclusion who declined being operated on prior to knowing to what group he was randomized. INTERVENTIONS: Laparoscopic gastric bypass and laparoscopic duodenal switch. MAIN OUTCOMES AND MEASURES: Body mass index and secondary outcomes including anthropometric measures, cardiometabolic risk factors, pulmonary function, vitamin status, gastrointestinal symptoms, health-related quality of life, and adverse events. RESULTS: Sixty patients were randomly assigned and operated on with gastric bypass (n = 31) and duodenal switch (n = 29). Fifty-five patients (92%) completed the study. Five years after surgery, the mean reductions in body mass index were 13.6 (95% CI, 11.0-16.1) and 22.1 (95% CI, 19.5-24.7) after gastric bypass and duodenal switch, respectively. The mean between-group difference was 8.5 (95% CI, 4.9-12.2; P < .001). Remission rates of type 2 diabetes mellitus and metabolic syndrome and changes in blood pressure and lung function were similar between groups. Reductions in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and fasting glucose were significantly greater after duodenal switch compared with gastric bypass. Serum concentrations of vitamin A and 25-hydroxyvitamin D were significantly reduced after duodenal switch compared with gastric bypass. Duodenal switch was associated with more gastrointestinal adverse effects. Health-related quality of life was similar between groups. Patients with duodenal switch underwent more surgical procedures related to the initial procedure (13 [44.8%] vs 3 [9.7%] patients; P = .002) and had significantly more hospital admissions compared with patients with gastric bypass. CONCLUSIONS AND RELEVANCE: In patients with a body mass index of 50 to 60, duodenal switch resulted in greater weight loss and greater improvements in low-density lipoprotein cholesterol, triglyceride, and glucose levels 5 years after surgery compared with gastric bypass while improvements in health-related quality of life were similar. However, duodenal switch was associated with more surgical, nutritional, and gastrointestinal adverse effects. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00327912.

[Dumping syndrome following gastric surgery]. / Dumpingsyndrom etter kirurgi på magesekken.

BACKGROUND: Dumping syndrome is the term used to describe a common set of symptoms following gastric surgery, and is characterised by postprandial discomfort which can entail nutritional problems. The condition was well known when surgery was the usual treatment for peptic ulcer disease. The increasing number of operations for morbid obesity means that the condition is once again of relevance, and health personnel will encounter these patients in different contexts. This article discusses the prevalence, symptomatology and treatment of dumping syndrome. MATERIAL AND METHOD: This review article is based on a selection of articles identified in PubMed and assessed as having particular relevance for elucidating this issue, as well as on the authors' own clinical experience. RESULTS: Early dumping syndrome generally occurs within 15 minutes of ingesting a meal and is attributable to the rapid transit of food into the small intestine. Nausea, abdominal pain, diarrhoea, a sensation of heat, dizziness, reduced blood pressure and palpitations are typical symptoms. Lethargy and sleepiness after meals are common. Late dumping syndrome occurs later and may be attributed to hypoglycaemia with tremors, cold sweats, difficulty in concentrating, and loss of consciousness. Dumping-related symptoms occur in between 20 and 50% of patients following gastric surgery. Early dumping syndrome is more frequent than late dumping syndrome. It is estimated that 10-20% of patients have pronounced symptoms and 1-5% have severe symptoms. The diagnosis is usually made on the basis of typical symptoms. Most patients experience alleviation of the symptoms over time and with changes in diet and eating habits. Further patient evaluation and drug or surgical intervention may be relevant for some individuals. INTERPRETATION: Dumping-related symptoms are common after gastric surgery. The extent of obesity surgery in particular means that health personnel should be familiar with this condition.

A comparison of behavioral and psychological characteristics of patients opting for surgical and conservative treatment for morbid obesity.

BACKGROUND: Little is known about the psychological prerequisites for weight loss maintenance after bariatric surgery. A first step in investigating whether existing knowledge of conservative weight loss treatment is applicable for lifestyle interventions postoperatively is to compare specific psychological characteristics at baseline. The aim of this study was to compare patients scheduled for bariatric surgery with patients receiving conservative treatment for morbid obesity on measures of behavioral and psychosocial characteristics considered predictors of their adoption of and adherence to long-term lifestyle recommendations. METHODS: Baseline clinical and questionnaire data from the prospective "Oslo Bariatric Surgery Study" were used to examine potential differences between bariatric surgery patients (n = 301) and patients receiving conservative weight loss treatment (n = 261). RESULTS: The surgical group was characterized by their younger age (43.8 vs. 46.2 years, p <0.01), higher percentage of women (79.1 vs. 70.1 %, p <0.05), and higher Body Mass Index (BMI; 45.0 vs. 41.9 kg/m(2), p <0.001). A multiple logistic regression analysis, adjusting for group differences in BMI, gender, and age, showed that the surgical group had higher self-efficacy (Odds ratio; OR = 3.44, 95 % Confidence interval; CI 1.65, 7.14), more positive outcome expectations (OR = 1.53, 95 % CI 1.23, 1.89), and plans that were more explicit for changing their eating behaviors (OR = 1.80, 95 % CI 1.06, 1.93). The surgical patients were also less ready to change physical activity levels (OR = 0.59, 95 % CI 0.48, 0.73), had tried more types of unhealthy weight loss methods in the past (OR = 1.16, 95 % CI 1.01, 1.33), drank soda more frequently (OR = 1.24, 95 % CI 1.02, 1.50), had fewer binge eating episodes (OR = 0.38, 95 % CI 0.20, 0.71), and had more depressive symptoms (OR = 1.19, 95 % CI 1.09, 1.29). CONCLUSIONS: Patients opting for bariatric surgery had more positive expectations of the treatment outcomes and stronger beliefs in their ability to achieve these outcomes. Those starting conservative treatment had stronger beliefs in readiness to change physical activity levels. Future studies should explore the effect of interventions for bariatric surgery patients, promoting postoperative physical activity and stress realistic outcome expectations. The potential effects of incorporating this knowledge in intervention strategies remain to be explored.