Hilde Risstad1, Torgeir T Søvik2, My Engström3, Erlend T Aasheim4, Morten W Fagerland5, Monika Fagevik Olsén3, Jon A Kristinsson4, Carel W le Roux6, Thomas Bøhmer7, Kåre I Birkeland4, Tom Mala8, Torsten Olbers3. 1. Department of Endocrinology, Morbid Obesity, and Preventive Medicine, Oslo University Hospital, Oslo, Norway2Institute of Clinical Medicine, University of Oslo, Oslo, Norway. 2. Department of Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway. 3. Department of Gastrosurgical Research and Education, Department of Surgery, Sahlgrenska University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden. 4. Department of Endocrinology, Morbid Obesity, and Preventive Medicine, Oslo University Hospital, Oslo, Norway. 5. Unit of Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway. 6. Department of Gastrosurgical Research and Education, Department of Surgery, Sahlgrenska University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden6Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dubl. 7. Nutritional Laboratory, Biochemical Department, Oslo University Hospital, Oslo, Norway. 8. Department of Endocrinology, Morbid Obesity, and Preventive Medicine, Oslo University Hospital, Oslo, Norway3Department of Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway.
Abstract
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.
RCT Entities:
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.
Authors: Rohan Khera; Ambarish Pandey; Apoorva K Chandar; Mohammad H Murad; Larry J Prokop; Ian J Neeland; Jarett D Berry; Michael Camilleri; Siddharth Singh Journal: Gastroenterology Date: 2018-01-03 Impact factor: 22.682
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