The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase (original) (raw)
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Gastric Banding or Bypass? A Systematic Review Comparing the Two Most Popular Bariatric Procedures
The American Journal of Medicine, 2008
OBJECTIVE: Bariatric surgical procedures have increased exponentially in the United States. Laparoscopic adjustable gastric banding is now promoted as a safer, potentially reversible and effective alternative to Roux-en-Y gastric bypass, the current standard of care. This study evaluated the balance of patient-oriented clinical outcomes for laparoscopic adjustable gastric banding and Roux-en-Y gastric bypass. METHODS: The MEDLINE database (1966 to January 2007, Cochrane clinical trials database, Cochrane reviews database, and Database of Abstracts of Reviews of Effects were searched using the key terms gastroplasty, gastric bypass, laparoscopy, Swedish band, and gastric banding. Studies with at least 1 year of follow-up that directly compared laparoscopic adjustable gastric banding with Roux-en-Y gastric bypass were included. Resolution of obesity-related comorbidities, percentage of excess body weight loss, quality of life, perioperative complications, and long-term adverse events were the abstracted outcomes. RESULTS: The search identified 14 comparative studies (1 randomized trial). Few studies reported outcomes beyond 1 year. Excess body weight loss at 1 year was consistently greater for Roux-en-Y gastric bypass than laparoscopic adjustable gastric banding (median difference, 26%; range, 19%-34%; P Ͻ .001). Resolution of comorbidities was greater after Roux-en-Y gastric bypass. In the highest-quality study, excess body weight loss was 76% with Roux-en-Y gastric bypass versus 48% with laparoscopic adjustable gastric banding, and diabetes resolved in 78% versus 50% of cases, respectively. Both operating room time and length of hospitalization were shorter for those undergoing laparoscopic adjustable gastric banding. Adverse events were inconsistently reported. Operative mortality was less than 0.5% for both procedures. Perioperative complications were more common with Roux-en-Y gastric bypass (9% vs 5%), whereas long-term reoperation rates were lower after Roux-en-Y gastric bypass (16% vs 24%). Patient satisfaction favored Roux-en-Y gastric bypass (P ϭ .006). CONCLUSION: Weight loss outcomes strongly favored Roux-en-Y gastric bypass over laparoscopic adjustable gastric banding. Patients treated with laparoscopic adjustable gastric banding had lower short-term morbidity than those treated with Roux-en-Y gastric bypass, but reoperation rates were higher among patients who received laparoscopic adjustable gastric banding. Gastric bypass should remain the primary bariatric procedure used to treat obesity in the United States.
Canadian journal of surgery. Journal canadien de chirurgie, 2016
Bariatric surgery in Canada is primarily delivered within publicly funded specialty clinics. Previous studies have demonstrated that bariatric surgery is superior to intensive medical management for reduction of weight and obesity-related comorbidities. Our objective was to compare the effectiveness and safety of laparoscopic Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (LSG) and adjustable gastric banding (LAGB) in a publicly funded, population-based bariatric treatment program. We followed consecutive bariatric surgery patients for 2 years. The primary outcome was weight change (in kilograms). Between-group changes were analyzed using multivariable regression. Last-observation-carried-forward imputation was used for missing data. We included 150 consecutive patients (51 RYGB; 51 LSG; 48 LAGB) in our study. At baseline, mean age was 43.5 ± 9.5 years, 87.3% of patients were women, and preoperative body mass index (BMI) was 46.2 ± 7.4. Absolute and relative (% of baseline) wei...
JAMA, 2018
IMPORTANCE Bariatric surgery is an effective and safe approach for weight loss and short-term improvement in metabolic disorders such as diabetes. However, studies have been limited in most settings by lack of a nonsurgical group, losses to follow-up, missing data, and small sample sizes in clinical trials and observational studies. OBJECTIVE To assess the association of 3 common types of bariatric surgery compared with nonsurgical treatment with mortality and other clinical outcomes among obese patients. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study in a large Israeli integrated health fund covering 54% of Israeli citizens with less than 1% turnover of members annually. Obese adult patients who underwent bariatric surgery between January 1, 2005, and December 31, 2014, were selected and compared with obese nonsurgical patients matched on age, sex, body mass index (BMI), and diabetes, with a final follow-up date of December 31, 2015. A total of 33 540 patients were included in this study. EXPOSURES Bariatric surgery (laparoscopic banding, Roux-en-Y gastric bypass, or laparoscopic sleeve gastrectomy) or usual care obesity management only (provided by a primary care physician and which may include dietary counseling and behavior modification). MAIN OUTCOMES AND MEASURES The primary outcome, all-cause mortality, matched and adjusted for BMI prior to surgery, age, sex, socioeconomic status, diabetes, hyperlipidemia, hypertension, cardiovascular disease, and smoking. RESULTS The study population included 8385 patients who underwent bariatric surgery (median age, 46 [IQR, 37-54] years; 5490 [65.5%] women; baseline median BMI, 40.6 [IQR, 38.5-43.7]; laparoscopic banding [n = 3635], gastric bypass [n = 1388], laparoscopic sleeve gastrectomy [n = 3362], and 25 155 nonsurgical matched patients (median age, 46 [IQR, 37-54] years; 16 470 [65.5%] women; baseline median BMI, 40.5 [IQR, 37.0-43.5]). The availability of follow-up data was 100% for all-cause mortality. There were 105 deaths (1.3%) among surgical patients during a median follow-up of 4.3 (IQR, 2.8-6.6) years (including 61 [1.7%] who underwent laparoscopic banding, 18 [1.3%] gastric bypass, and 26 [0.8%] sleeve gastrectomy), and 583 deaths (2.3%) among nonsurgical patients during a median follow-up of 4.0 (IQR, 2.6-6.2) years. The absolute difference was 2.51 (95% CI, 1.86-3.15) fewer deaths/1000 person-years in the surgical vs nonsurgical group. Adjusted hazard ratios (HRs) for mortality among nonsurgical vs surgical patients were 2.02 (95% CI, 1.63-2.52) for the entire study population; by surgical type, HRs were 2.01 (95% CI, 1.50-2.69) for laparoscopic banding, 2.65 (95% CI, 1.55-4.52) for gastric bypass, and 1.60 (95% CI, 1.02-2.51) for laparoscopic sleeve gastrectomy. CONCLUSIONS AND RELEVANCE Among obese patients in a large integrated health fund in Israel, bariatric surgery using laparoscopic banding, gastric bypass, or laparoscopic sleeve gastrectomy, compared with usual care nonsurgical obesity management, was associated with lower all-cause mortality over a median follow-up of approximately 4.5 years. The evidence of this association adds to the limited literature describing beneficial outcomes of these 3 types of bariatric surgery compared with usual care obesity management alone.
Medicine, 2019
Background: Laparoscopic adjustable gastric banding (LAGB) and laparoscopic sleeve gastrectomy (LSG) are common weight loss procedures. Our meta-analysis compared these procedures for the treatment of morbid obesity and related diseases. Methods: We systematically searched the PubMed, Embase, and the Cochrane Library through January 2018. The percentage of excess weight loss (%EWL), improvement or remission of type 2 diabetes mellitus (T2DM) and hypertension were analyzed and compared. Results: Thirty-three studies with 4109 patients were included. Greater decreases in excess weight were found in patients who received LSG at 6 months (weighted mean difference (WMD) À9.29, 95% confidence interval (CI): À15.19 to À3.40, P = .002), 12 months (WMD À16.67 95% CI: À24.30 to À9.05, P < .0001), 24 months (WMD À19.63, 95% CI: À29.00 to À10.26, P < .0001), and 36 months (WMD À19.28, 95% CI: À27.09 to À11.47, P < .0001) than in patients who received LAGB. However, there were no significant differences in the 3-month outcomes between the 2 groups (WMD À1.61, 95% CI: À9.96 to 6.73, P = .70). T2DM patients after LSG experience more significant improvement or remission of diabetes (odds ratio (OR): 0.22, 95% CI: 0.06-0.87, P = .03). The 2 groups did not significantly differ regarding improvement or remission of hypertension (OR 0.80, 95% CI: 0.46-1.38, P = .42). Conclusion: LSG is a more effective procedure than LAGB for morbidly obese patients, contributing to a higher %EWL and greater improvement in T2DM. Abbreviations: %EWL = percentage of excess weight loss, BMI = body mass index, BP = blood pressure, BPD = biliopancreatic diversion, CIs = confidence intervals, LAGB = laparoscopic adjustable gastric banding, LRYGB = laparoscopic Roux-en-Y gastric bypass, LSG = laparoscopic sleeve gastrectomy, MeSH = medical subject heading, OR = odds ratio, RCTs = randomized controlled trials, T2DM = type 2 diabetes mellitus, WHO = World Health Organization, WMD = weighted mean difference.
BMC Surgery, 2015
Background: Roux-en-Ygastric bypass (RYGB) and sleeve gastrectomy (SG) rank among the most frequently applied bariatric procedures worldwide due to their positive risk/benefit correlation. A systematic review revealed a similar excess weight loss (EWL) 2 years postoperatively between SG and RYGB. However, there is a lack of randomized controlled multi-centre trials comparing SG and RYGB, not only concerning EWL, but also in terms of remission of obesity-related co-morbidities, gastroesophageal reflux disease (GERD) and quality of life (QoL) in the mid-and long-term. Methods: The BariSurg trial was designed as a multi-centre, randomized controlled patient and observer blind trial. The trial protocol was approved by the corresponding ethics committees of the centres. To demonstrate EWL non-inferiority of SG compared to RYGB, power calculation was performed according to a non-inferiority study design. Morbidity, mortality, remission of obesity-related co-morbidities, GERD course and QoL are major secondary endpoints. 248 patients between 18 and 70 years, with a body mass index (BMI) between 35-60 kg/m 2 and indication for bariatric surgery according to the most recent German S3-guidelines will be randomized. The primary and secondary endpoints will be assessed prior to surgery and afterwards at discharge and at the time points 3-6, 12, 24, 36, 48 and 60 months postoperatively. Discussion: With its five year follow-up, the BariSurg-trial will provide further evidence based data concerning the impact of SG and RYGB on EWL, remission of obesity-related co-morbidities, the course of GERD and QoL. Trial registration: The trial protocol has been registered in the German Clinical Trials Register DRKS00004766.
Obesity Surgery, 2014
Background Laparoscopic adjustable gastric band (LAGB), laparoscopic sleeve gastrectomy (LSG), and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most performed procedures worldwide (92 %) nowadays. However, comparative clinical trials are scarce in literature. The objective of this study was to compare the effectiveness and safety of the three most performed bariatric procedures. Methods A multicenter, retrospective, matched cohort study was conducted. Patients were eligible for analysis when a primary procedure was performed between 2007 and 2010 in one of the two specialized bariatric centers. Primary outcome was weight loss, expressed in the percentage excess weight loss (%EWL). Secondary outcome parameters are hospital stay, complication rate, and revisional surgery. Results In total, 735 patients, 245 in each group, were included for analysis. The groups were comparable for age and gender after matching. Mean postoperative follow-up was 3.1±1.2 years. LAGB patients showed less %EWL compared to LSG and LRYGB at all postoperative follow-up visits. LRYGB showed a %EWL of 71±20 % compared to LSG (76±23 %; p=0.008) after 1-year follow-up; thereafter, no significant difference was observed. After 3 years of follow-up, LAGB showed a higher complication rate compared to LSG and LRYGB (p<0.05). Revisional surgery after LAGB was needed in 21 %, while 9 % of the LSG underwent conversion to RYGB. Conclusions LRYGB is a safe and effective treatment in morbid obese patients with good long-term outcomes. LSG seems to be an appropriate alternative as a definitive procedure, in terms of weight reduction and complication rate. LAGB is inferior to both LRYGB and LSG.
Annals of Surgery, 2004
Objective: To define whether laparoscopic gastric banding or laparoscopic Roux-en-Y gastric bypass represents the better approach to treat patients with morbid obesity. Summary Background Data: Two techniques, laparoscopic gastric bypass or gastric banding, are currently widely used to treat morbid obesity. Since both procedures offer certain advantages, a strong controversy exists as to which operation should be proposed to these patients. Therefore, data are urgently needed to identify the best therapy. Methods: Since randomized trials are most likely not feasible because of the highly different invasiveness and irreversibility of these procedures, a matched-pair design of a large prospectively collected database appears to be the best method. Therefore, we used our prospective database including 678 bariatric procedures performed at our institution since 1995. A total of 103 consecutive patients with laparoscopic gastric bypass were randomly matched to 103 patients with laparoscopic gastric banding according to age, body mass index, and gender. Results: Both groups were comparable regarding age, gender, body mass index, excessive weight, fat mass, and comorbidites such as diabetes, heart disease, and hypertension. Feasibility and safety: All gastric banding procedures were performed laparoscopically, and one gastric bypass operation had to be converted to an open procedure. Mean operating time was 145 minutes for gastric banding and 190 minutes for gastric bypass (P Ͻ 0.001). Hospital stay was 3.3 days for gastric banding and 8.4 days for gastric bypass. The incidence of early postoperative complications was not significantly different, but late complications were significantly more frequent in the gastric banding group (pouch dilatation). There was no mortality in both groups. Efficiency: Body mass index decreased from 48.0 to 36.8 kg/m 2 in the gastric banding group and from 47.8 to 31.9 kg/m 2 in the gastric bypass group within 2 years of surgery. These differences became significant from the first postoperative month until the end of the follow-up (24 months). The gastric bypass procedure achieved a significantly better reduction of comorbidities. Conclusions: Laparoscopic gastric banding and laparoscopic gastric bypass are feasible and safe. Pouch dilatations after gastric banding are responsible for more late complications compared with the gastric bypass. Laparoscopic gastric bypass offers a significant advantage regarding weight loss and reduction of comorbidities after surgery. Therefore, in our hands, laparoscopic Roux-en-Y gastric bypass appears to be the therapy of choice. (Ann Surg 2004;240: 975-983)
Bariatric surgery: a systematic review and network meta‐analysis of randomized trials
Obesity …, 2011
The clinical efficacy and safety of bariatric surgery trials were systematically reviewed. MEDLINE, EMBASE, CENTRAL were searched to February 2009. A basic PubCrawler alert was run until March 2010. Trial registries, HTA websites and systematic reviews were searched. Manufacturers were contacted. Randomized trials comparing bariatric surgeries and/or standard care were selected. Evidence-based items potentially indicating risk of bias were assessed. Network meta-analysis was performed using Bayesian techniques. Of 1838 citations, 31 RCTs involving 2619 patients (mean age 30-48 y; mean BMI levels 42-58 kg/m 2 ) met eligibility criteria. As compared with standard care, differences in BMI levels from baseline at year 1 (15 trials; 1103 participants) were as follows: jejunoileal bypass [MD: -11.4 kg/m 2 ], mini-gastric bypass [-11.3 kg/m 2 ], biliopancreatic diversion [-11.2 kg/m 2 ], sleeve gastrectomy [-10.1 kg/m 2 ], Roux-en-Y gastric bypass [-9.0 kg/m 2 ], horizontal gastroplasty [-5.0 kg/m 2 ], vertical banded gastroplasty [-6.4 kg/m 2 ], and adjustable gastric banding [-2.4 kg/m 2 ]. Bariatric surgery appears efficacious compared to standard care in reducing BMI. Weight losses are greatest with diversionary procedures, intermediate with diversionary/restrictive procedures, and lowest with those that are purely restrictive. Compared with Roux-en-Y gastric bypass, adjustable gastric banding has lower weight loss efficacy, but also leads to fewer serious adverse effects.
Obesity Surgery, 2020
Background Banded sleeve gastrectomy (BSG), a modification of the laparoscopic sleeve gastrectomy (SG), and one anastomotic gastric bypass/mini-gastric bypass (OAGB/MGB), a modification to the Roux-en-Y gastric bypass (RYGB), have been reported to enhance weight loss and minimize significant weight regain when compared with the SG and RYGB respectively. However, there has not been any report or study comparing these two operations. Objective We did a retrospective cohort study comparing these two operations and present a review and analysis with follow-up for 6 years. Method A review of all the operations performed at MBRSC in 2011 from a prospectively maintained database was done. Patients who had either a BSG or OAGB/MGB were identified. Data on the patients' profile, co-morbid conditions, perioperative complications, late complications, weight loss, resolution of comorbidities, and changes in quality of life (QLF) were collected reviewed and analyzed. Result Sixty-eight patients were identified who had a primary BSG and 55 who had an OAGB/MGB in 2011. The follow-up rate, the age, BMI, and gender composition were similar in both groups. There were more patients with type 2 diabetes (T2D) in the BSG group than in the OAGB/MGB group (44.1% vs. 27.2%). The incidences of hypertension (HTN) and obstructive sleep apnea (OSA) were higher in the OAGB/MGB group (62% vs. 36% and 96.3% vs. 2.9% respectively). The weight loss was faster in the OAGB/MGB group in the first year, but by the sixth year, the weight loss was slightly higher in the BSG group (84% vs. 79%). Resolution rate of T2D and HTN was higher after the OAGB/MGB group, 86.6% vs. 75.7% and 85.3% vs. 64.0% respectively. There was a 20% incidence of nutrient deficiencies in OAGB/MGB group and none in the BSG group. Conclusion Both operations produced excellent weight loss and maintenance in the short to intermediate term. There was better resolution of T2D and HTN after OAGB/MGB at the expense of a higher incidence of nutrient deficiency and some protein caloric malnutrition. There is need for prospective and larger series studies to confirm these findings.