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Comparative risk of fracture for bariatric procedures in patients with obesity: A systematic review and Bayesian network meta-analysis.
Zhang, Q, Dong, J, Zhou, D, Liu, F
International journal of surgery (London, England). 2020;:13-23
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Abstract
OBJECTIVE Bariatric surgery (malabsorptive [i.e., biliopancreatic diversion, BPD], restrictive [i.e., sleeve gastrectomy, SG; adjustable gastric banding, AGB] and mixed [i.e., gastric bypass, GB] procedures) has been reported to be associated with an increased risk of fracture; however, which procedure poses the greatest risk of fracture is still controversial. The aim of the current meta-analysis was to investigate the degree of fracture risk after different bariatric procedures. MATERIAL AND METHODS Electronic databases, including Medline/PubMed, EMBASE and Cochrane library, were systematically searched from inception to July 11, 2019 with no language restrictions to retrieve randomized controlled trials (RCTs) or cohort studies evaluating the impact of any kind of bariatric surgery on postoperative fractures in patients with obesity. Pairwise meta-analysis and Bayesian network meta-analysis were performed to pool the outcome estimates of interest, including fracture incidence and fracture risk. The values of the surface under the cumulative ranking (SUCRA) probability for fracture risk were calculated and sorted according to the different surgical procedures. RESULTS A total of twelve studies published between 2010 and 2019, comprising 159,916 participants with obesity were identified for the analysis. The incidence of fracture increased from 3% (95% confidence interval [CI] 2-4%) in patients with non-surgical intervention (drug treatment, alteration in life style and diet control) to 5% (95% CI 4-7%) in those who had undergone bariatric surgery (pooled relative risk [RR] = 1.41 95% CI: 1.22-1.63). Network meta-analysis revealed that based on the SUCRA ranking of the different surgical procedures, the malabsorptive procedure had the highest possibility of increased fracture risk in patients with obesity (74.75%), followed by the mixed procedures (73.85%), nonsurgical intervention (43.55%) and the restrictive procedure (7.85%); for different surgery types. The BPD group had the highest possibility of increased fracture risk (99.49%), followed by the GB (74.92%), nonsurgical intervention (44.49%), AGB (26.64%) and SG (4.45%) groups. CONCLUSIONS Significant differences exist among different bariatric surgeries impacting on fracture risk. The malabsorptive and mixed procedures, but not the restrictive procedure, increase the postoperative risk of fracture. Considering the weight-reduction effects and fracture risk, the sleeve gastrectomy procedure may be the best choice for patients with obesity, especially those who are susceptible to osteoporosis.
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Randomized clinical trial of an enhanced recovery after surgery programme versus conventional care in laparoscopic Roux-en-Y gastric bypass surgery.
Geubbels, N, Evren, I, Acherman, YIZ, Bruin, SC, van de Laar, AWJM, Hoen, MB, de Brauw, LM
BJS open. 2019;(3):274-281
Abstract
BACKGROUND Enhanced recovery after surgery (ERAS) programmes have led to a decreased duration of hospital stay in several surgical fields, but have not been fully tested in patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) for obesity. This study aimed to investigate an ERAS programme versus standard care in these patients. METHODS Between January 2013 and July 2014, patients undergoing LRYGB were randomized to ERAS or conventional care. The primary outcome was functional hospital stay, defined as the time between end of surgery and when predefined discharge criteria (pain adequately controlled, fever and postoperative nausea and vomiting (PONV) absent, full liquid diet tolerated, mobilized and feeling fit for discharge) were met. Secondary outcomes were total length of hospital stay, 30-day complication and mortality rates, duration of surgery, time spent on the recovery ward and health-related quality of life. RESULTS A total 220 patients were randomized to ERAS (110 patients) or conventional (110) care. Patients in the ERAS group had shorter functional hospital stay (17·4 versus 20·5 h; P < 0·001), quicker pain control, tolerated liquid diet earlier, had earlier control of PONV, mobilized sooner and were comfortable with discharge sooner than those receiving conventional care. Total length of hospital stay, duration of surgery, time spent on the recovery ward, health-related quality of life, complication and readmission rates did not differ between the study groups. There were no deaths. CONCLUSION Patients under ERAS care recovered faster after LRYGB surgery than those receiving conventional care, with no increase in readmission and postoperative morbidity rates. Registration number: NTR3853 (http://www.trialregister.nl/).
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Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial.
Simonson, DC, Vernon, A, Foster, K, Halperin, F, Patti, ME, Goldfine, AB
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2019;(12):2052-2059
Abstract
BACKGROUND Few randomized trials have compared surgical versus lifestyle and pharmacologic approaches for type 2 diabetes (T2D) patients with mild to moderate obesity. OBJECTIVES This study examined resolution of hyperglycemia (A1C <6.5% and fasting glucose <126 mg/dL) 3 years after randomization to either a laparoscopic adjustable gastric band (LAGB) or 1-year diabetes and weight management (DWM) program. SETTING University medical center, United States. METHODS Forty T2D patients (mean ± SD: age, 51.3 ±10.0 yr; weight 109.5 ± 15.0 kg; body mass index [BMI] 36.5 ± 3.7 kg/m2; HBA1C 8.2% ± 1.2%) were randomized to LAGB (n = 18) or DWM (n = 22). RESULTS At 3 years, 13% of 16 patients in LAGB and 5% of 17 patients in DWM achieved resolution of hyperglycemia (P = .601), with a modestly greater reduction in antidiabetic medications in the surgical group (P = .054). Reductions from baseline in A1C were sustained at 3 years in LAGB (-.82% [95% CI: -1.62 to -.01], P = .046) compared with DWM (+.23% [95% CI: -.57 to 1.03], P = .567). The surgical group had greater weight loss (-12.0 kg [95% CI: -15.9 to -8.1] versus -4.8 [95% CI: -8.6 to -.9], P = .010). HDL-cholesterol increased more after surgery (P = .003), but changes in triglycerides, LDL-cholesterol, and blood pressure did not differ between treatments. Diabetes- and obesity-specific quality of life improved comparably with both therapies. CONCLUSIONS Achievement of American Diabetes Association targets for glucose, lipids, and blood pressure was similar with both treatment strategies. LAGB leads to greater sustained weight loss and higher HDL cholesterol compared with a DWM program. These findings may help guide patients with T2D and obesity when exploring options for diabetes and weight management.
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Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial.
Robert, M, Espalieu, P, Pelascini, E, Caiazzo, R, Sterkers, A, Khamphommala, L, Poghosyan, T, Chevallier, JM, Malherbe, V, Chouillard, E, et al
Lancet (London, England). 2019;(10178):1299-1309
Abstract
BACKGROUND One anastomosis gastric bypass (OAGB) is increasingly used in the treatment of morbid obesity. However, the efficacy and safety outcomes of this procedure remain debated. We report the results of a randomised trial (YOMEGA) comparing the outcomes of OAGB versus standard Roux-en-Y gastric bypass (RYGB). METHODS This prospective, multicentre, randomised non-inferiority trial, was held in nine obesity centres in France. Patients were eligible for inclusion if their body-mass index (BMI) was 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, or arthritis), and were aged 18-65 years. Key exclusion criteria were a history of oesophagitis, Barrett's oesophagus, severe gastro-oesophageal reflux disease resistant to proton-pump inhibitors, and previous bariatric surgery. Participants were randomly assigned (1:1) to OAGB or RYGB, stratified by centre with blocks of variable size; the study was open-label, with no masking required. RYGB consisted of a 150 cm alimentary limb and a 50 cm biliary limb and OAGB of a single gastrojejunal anastomosis with a 200 cm biliopancreatic limb. The primary endpoint was percentage excess BMI loss at 2 years. The primary endpoint was assessed in the per-protocol population and safety was assessed in all randomised participants. This study is registered with ClinicalTrials.gov, number NCT02139813, and is now completed. FINDINGS From May 13, 2014, to March 2, 2016, of 261 patients screened for eligibility, 253 (97%) were randomly assigned to OAGB (n=129) or RYGB (n=124). Five patients did not undergo their assigned surgery, and after undergoing their surgery 14 were excluded from the per-protocol analysis (seven due to pregnancy, two deaths, one withdrawal, and four revisions from OAGB to RYGB) In the per-protocol population (n=117 OAGB, n=117 RYGB), mean age was 43·5 years (SD 10·8), mean BMI was 43·9 kg/m2 (SD 5·6), 176 (75%) of 234 participants were female, and 58 (27%) of 211 with available data had type 2 diabetes. After 2 years, mean percentage excess BMI loss was -87·9% (SD 23·6) in the OAGB group and -85·8% (SD 23·1) in the RYGB group, confirming non-inferiority of OAGB (mean difference -3·3%, 95% CI -9·1 to 2·6). 66 serious adverse events associated with surgery were reported (24 in the RYGB group vs 42 in the OAGB group; p=0·042), of which nine (21·4%) in the OAGB group were nutritional complications versus none in the RYGB group (p=0·0034). INTERPRETATION OAGB is not inferior to RYGB regarding weight loss and metabolic improvement at 2 years. Higher incidences of diarrhoea, steatorrhoea, and nutritional adverse events were observed with a 200 cm biliopancreatic limb OAGB, suggesting a malabsorptive effect. FUNDING French Ministry of Health.
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Comparison of Repeat Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in Case of Weight Loss Failure After Sleeve Gastrectomy.
Antonopulos, C, Rebibo, L, Calabrese, D, Ribeiro-Parenti, L, Arapis, K, Dhahri, A, Coupaye, M, Hansel, B, Marmuse, JP, Regimbeau, JM, et al
Obesity surgery. 2019;(12):3919-3927
Abstract
BACKGROUND Few series are available on the results of repeat sleeve gastrectomy (re-SG) and Roux-en-Y gastric bypass (RYGB) performed to manage the failure of primary sleeve gastrectomy (SG). The objective of this study was to compare the short- and medium-term outcomes of re-SG and RYGB after SG. MATERIAL & METHODS Between January 2010 and December 2017, patients undergoing re-SG (n = 61) and RYGB (n = 83) for failure of primary SG were included in this study. Revisional surgery was proposed for patients with insufficient excess weight loss (EWL ≤ 50%) or weight regain. The primary endpoint was the comparison of weight loss in the re-SG group and the RYGB group at the 1-year follow-up. The secondary endpoints were overall mortality and morbidity, specific morbidity, length of stay, weight loss, and correction of comorbidities. RESULTS The mean interval between SG and re-SG was 41.5 vs. 43.2 months between SG and RYGB (p = 0.32). The mean operative time was 103 min (re-SG group) vs. 129.4 min (RYGB group). One death (1.7%; re-SG group) and 25 complications (17.4%; 9 in the re-SG group, 16 in the RYGB group) were observed. At the 1 year, mean body mass index was 31.6 in the re-SG group and 32.5 in the RYGB group (p = 0.61) and excess weight loss was 69.5 vs. 61.2, respectively (p = 0.05). CONCLUSION Re-SG and RYGB as revisional surgery for SG are feasible with acceptable outcomes and similar results on weight loss on the first postoperative year.
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Laparoscopic Roux-en-Y gastric bypass vs. laparoscopic sleeve gastrectomy for morbid obesity: a systematic review and meta-analysis of lipid effects at one year postsurgery.
Climent, E, Benaiges, D, Pedro-Botet, J, Goday, A, Solà, I, Ramón, JM, Flores-LE Roux, JA, Checa, MÁ
Minerva endocrinologica. 2018;(1):87-100
Abstract
INTRODUCTION Results of the effects of Roux-en-Y gastric bypass (GB) and sleeve gastrectomy (SG) on triglyceride and high-density lipoprotein (HDL) cholesterol levels are controversial. Moreover, previous meta-analyses focused on global dyslipidemia remission, but did not include the separate remission rates of the different lipid fractions. Hence, the aim of the present meta-analysis was to compare the outcomes (concentration change and remission rates) of GB and SG on diverse lipid disorders one year postbariatric surgery (BS). EVIDENCE ACQUISITION An exhaustive electronic search carried out on MedLine, Embase and The Cochrane Central Register of Controlled Trials (Central) until July 2016 yielded 2621 records, of which 17, totaling 4699 obese patients with one-year follow-up after BS were included in the meta-analysis. EVIDENCE SYNTHESIS GB was superior to SG in terms of total cholesterol (mean difference= 19.77 mg/dL, 95% CI: 11.84-27.69) and low-density lipoprotein (LDL) cholesterol (mean difference: 19.29 mg/dL, 95% CI: 11.93-26.64) decreases as well as in hypercholesterolemia remission (RR: 1.43, 95% CI: 1.27-1.61). No differences were found between GB and SG in terms of HDL cholesterol increase or triglyceride concentration change after surgery, as well as in hypertriglyceridemia and low HDL remission rates. CONCLUSIONS The effect of GB on total and LDL cholesterol concentration decreases and remission was greater than that of SG, whereas no differences were observed with respect to HDL cholesterol and triglyceride concentration evolution. Conclusions cannot be drawn from hypertriglyceridemia and low HDL remission rates based on this meta-analysis.
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Randomized trial of Roux-en-Y gastric bypass versus sleeve gastrectomy in achieving excess weight loss.
Ignat, M, Vix, M, Imad, I, D'Urso, A, Perretta, S, Marescaux, J, Mutter, D
The British journal of surgery. 2017;(3):248-256
Abstract
BACKGROUND Robust data on quality of life (QoL) after different techniques of bariatric surgery are sparse. This RCT compared excess weight loss (EWL) and QoL after sleeve gastrectomy versus Roux-en-Y gastric bypass (RYGB). METHODS Obese patients were assigned randomly to RYGB or sleeve gastrectomy. The primary outcome measure was EWL. Secondary outcomes included QoL, co-morbidity, adverse events, vitamin and glycolipid status. QoL was assessed before and annually after surgery, using the Moorehead-Ardelt Quality of Life Questionnaire II (M-A-QoLQII) and Gastrointestinal Quality of Life Index (GIQLI). RESULTS One hundred patients were enrolled, 45 in the RYGB group and 55 in the sleeve gastrectomy group. Mean postoperative EWL at 1, 2, 3 and 5 years was 80·4, 79·8, 83·0 and 74·8 per cent respectively after RYGB, and 83·0, 77·8, 66·3 and 65·1 per cent after sleeve gastrectomy (P = 0·017). Mean M-A-QoLQII score before surgery and at 1, 2, 3 and 5 years after operation was 0·5, 1·6, 1·7, 2·1 and 1·4 respectively after RYGB, and 0·3, 1·7, 1·5, 1·5 and 1·2 after sleeve gastrectomy. Mean GIQLI score before and at 1, 2, 3, 5 years after RYGB was 96·4, 113·8, 113·3, 113·4, 111·7, compared with 90·7, 113·9, 114·5, 113·1 and 113·0 for sleeve gastrectomy. The improvement was significant compared with preoperative values (P < 0·001 for M-A-QoLQII and GIQLI), with no difference between groups (P = 0·418 and P = 0·323 respectively). RYGB resulted in higher readmission rates (P = 0·002) and length of hospital stay (P = 0·006) than sleeve gastrectomy. CONCLUSION RYGB and sleeve gastrectomy resulted in equivalent, long-standing QoL improvement. RYGB resulted in more stable weight loss but was associated with higher readmission rates. Registration number: NCT02475590.
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Weight Loss Outcomes in Laparoscopic Vertical Sleeve Gastrectomy (LVSG) Versus Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) Procedures: A Meta-Analysis and Systematic Review of Randomized Controlled Trials.
Osland, E, Yunus, RM, Khan, S, Memon, B, Memon, MA
Surgical laparoscopy, endoscopy & percutaneous techniques. 2017;(1):8-18
Abstract
PURPOSE Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic vertical sleeve gastrectomy (LVSG) have been proposed as cost-effective strategies to manage morbid obesity. The aim of this meta-analysis was to compare the postoperative weight loss outcomes reported in randomized control trials (RCTs) for LVSG versus LRYGB procedures. MATERIAL AND METHODS RCTs comparing the weight loss outcomes following LVSG and LRYGB in adult population between January 2000 and November 2015 were selected from PubMed, Medline, Embase, Science Citation Index, Current Contents, and the Cochrane database. The review was prepared in accordance with Preferred Reporting of Systematic Reviews and Meta-Analyses (PRISMA). RESULTS Nine unique RCTs described over 10 publications involving a total of 865 patients (LVSG, n=437; LRYGB, n=428) were analyzed. Postoperative follow-up ranged from 3 months to 5 years. Twelve-month excess weight loss (EWL) for LVSG ranged from 69.7% to 83%, and for LRYGB, ranged from 60.5% to 86.4%. A number of studies reported slow weight gain between the second and third years of postoperative follow-up ranging from 1.4% to 4.2%EWL. This trend was seen to continue to 5 years postoperatively (8% to 10%EWL) for both procedures. CONCLUSIONS In conclusion, LRYGB and LVSG are comparable with regards to the weight loss outcomes in the short term, with LRYGB achieving slightly greater weight loss. Slow weight recidivism is observed after the first postoperative year following both procedures. Long-term reporting of outcomes obtained from well-designed studies using intention-to-treat analyses are identified as a major gap in the literature at present.
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Late Postoperative Complications in Laparoscopic Sleeve Gastrectomy (LVSG) Versus Laparoscopic Roux-en-y Gastric Bypass (LRYGB): Meta-analysis and Systematic Review.
Osland, E, Yunus, RM, Khan, S, Memon, B, Memon, MA
Surgical laparoscopy, endoscopy & percutaneous techniques. 2016;(3):193-201
Abstract
AIMS AND OBJECTIVES Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic vertical sleeve gastrectomy (LVSG), have been proposed as cost-effective strategies to manage obesity-related chronic disease. The objectives of this meta-analysis and systematic review were to analyze the "late postoperative complication rate (>30 days)" for these 2 procedures. MATERIALS AND METHODS Randomized controlled trials (RCTs) published between 2000 and 2015 comparing the late complication rates, that is, >30 days following LVSG and LRYGB in adult population (ie, 16 y and above) were selected from PubMed, Medline, Embase, Science Citation Index, Current Contents, and the Cochrane database. The outcome variables analyzed included mortality rate, major and minor complications, and interventions required for their management and readmission rates. Random effects model was used to calculate the effect size of both binary and continuous data. Heterogeneity among the outcome variables of these trials was determined by the Cochran Q statistic and I index. The meta-analysis was prepared in accordance with the Preferred Reporting of Systematic Reviews and Meta-Analyses guidelines. RESULTS Six RCTs involving a total of 685 patients (LVSG, n=345; LRYGB, n=340) reported late major complications. A nonstatistical reduction in relative odds favoring the LVSG procedure was observed [odds ratio (OR), 0.64; 95% confidence interval (CI), 0.21-1.97; P=0.4]. Four RCTs representing 408 patients (LVSG, n=208; LRYGB, n=200) reported late minor complications. A nonstatistically significant reduction of 36% in relative odds favoring the LVSG procedure was observed (OR, 0.64; 95% CI, 0.28-1.47; P=0.3). A 37% relative reduction in odds was observed in favor of the LVSG for the need for additional interventions to manage late postoperative complications that did not reach statistical significance (OR, 0.63; 95% CI, 0.19-2.05; P=0.4). No study specifically reported readmissions required for the management of late complication. CONCLUSIONS This meta-analysis and systematic review of RCTs shows that the development of late (major and minor) complications is similar between LVSG and LRYGB procedures, 6 months to 3 years postoperatively, and they do not lead to higher readmission rate or reoperation rate for either procedure. However longer-term surveillance is required to accurately describe the patterns of late complications in these patients.
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Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study.
Horbach, T, Meyer, G, Morales-Conde, S, Alarcón, I, Favretti, F, Anselmino, M, Rovera, GM, Dargent, J, Stroh, C, Susewind, M, et al
International journal of obesity (2005). 2016;(12):1891-1898
Abstract
OBJECTIVE To compare the weight loss, change in quality of life (QOL) and safety of closed-loop gastric electrical stimulation (CLGES) versus adjustable gastric band (LAGB) in the treatment of obesity. METHODS This multicenter, randomized, non-inferiority trial randomly assigned the patients in a 2:1 ratio to laparoscopic CLGES versus LAGB and followed them for 1 year. We enrolled 210 patients, of whom 50 were withdrawn preoperatively. Among 160 remaining patients (mean age=39±11 years; 75% women; mean body mass index=43±6 kg m-2) 106 received CLGES and 54 received LAGB. The first primary end point was non-inferiority of CLGES versus LAGB, ascertained by the proportion of patients who, at 1 year, fulfilled: (a) a ⩾20% excess weight loss (EWL); (b) no major device- or procedure-related adverse event (AE); and (c) no major, adverse change in QOL. Furthermore, ⩾50% of patients had to reach ⩾25% EWL. The incidence and seriousness of all AE were analyzed and compared using Mann-Whitney's U-test. RESULTS At 1 year, the proportions of patients who reached all components of the primary study end point were 66.7 and 73.0% for the LAGB and CLGES group, respectively, with a difference of -6.3% and an upper 95% CI of 7.2%, less than the predetermined 10% margin for confirming the non-inferiority of CLGES. The second primary end point was also met, as 61.3% of patients in the CLGES group reached ⩾25% EWL (lower 95% CI=52.0%; P<0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (P<0.001). CONCLUSIONS AND RELEVANCE This randomized study confirmed the non-inferiority of CLGES compared with LAGB based on the predetermined composite end point. CLGES was associated with significantly fewer major AE.