Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Surgery for Obesity- An Update of a Randomized Trial. Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic vertical banded gastroplasty for obesity. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. Open versus laparoscopic vertical banded gastroplasty: a randomized controlled double blind trial. Minimal interventions for weight control: a cost-effective alternative. Laparoscopic adjustable gastric banding versus open vertical banded gastroplasty: a prospective randomized trial. Open versus laparoscopic adjustable silicone gastric banding: a prospective randomized trial for treatment of morbid obesity. Prospective randomized trial of banded versus nonbanded gastric bypass for the super obese: early results.
Obesity is a major, growing health problem. Observational studies suggest that bariatric surgery is more effective than nonsurgical therapy, but no randomized, controlled trials have confirmed this.
                To ascertain whether surgical therapy for obesity achieves better weight loss, health, and quality of life than nonsurgical therapy.
                Randomized, controlled trial.
                University departments of medicine and surgery and an affiliated private hospital.
                80 adults with mild to moderate obesity (body mass index, 30 kg/m2 to 35 kg/m2) from the general community. Interventions: Patients were assigned to a program of very-low-calorie diets, pharmacotherapy, and lifestyle change for 24 months (nonsurgical group) or to placement of a laparoscopic adjustable gastric band (LAP-BAND System, INAMED Health, Santa Barbara, California) (surgical group).
                Outcome measures were weight change, presence of the metabolic syndrome, and change in quality of life at 2 years.
                At 2 years, the surgical group had greater weight loss, with a mean of 21.6% (95% CI, 19.3% to 23.9%) of initial weight lost and 87.2% (CI, 77.7% to 96.6%) of excess weight lost, while the nonsurgical group had a loss of 5.5% (CI, 3.2% to 7.9%) of initial weight and 21.8% (CI, 11.9% to 31.6%) of excess weight (P < 0.001). The metabolic syndrome was initially present in 15 (38%) patients in each group and was present in 8 (24%) nonsurgical patients and 1 (3%) surgical patient at the completion of the study (P < 0.002). Quality of life improved statistically significantly more in the surgical group (8 of 8 subscores of Short Form-36) than in the nonsurgical group (3 of 8 subscores).
                The study included mildly and moderately obese participants, was not powered for comparison of adverse events, and examined outcomes only for 24 months.
                Surgical treatment using laparoscopic adjustable gastric banding was statistically significantly more effective than nonsurgical therapy in reducing weight, resolving the metabolic syndrome, and improving quality of life during a 24-month treatment program. BACKGROUND: A prospective, randomized trial comparing vertical banded gastroplasty (VBG) and gastric bypass (GB) was performed on 106 patients between 1987 and 1990. METHODS AND RESULTS: Failures of these two operations (manifested by failure to lose weight, late weight gain or intolerance of adequate oral intake) were treated by means of a third operation, isolated gastric bypass (IGB), in which the small gastric pouch was isolated from the gastric fundus. The latter operation was significantly better than VBG or GB and achieved a 63% success rate, i.e. body mass index (BMI) < 35 kg m(2) and less than 50% excess weight. During the year following this trial an additional 54 patients underwent IGB. When this operation was performed for morbid obesity and was the Initial procedure, 96% of the patients achieved a successful result. If IGB was performed as a revision procedure or for super obesity (BMI > 50 kg m(2)), the success rate was 63% with 100% follow-up at 40 months. Major morbidity occurred in six of the 160 patients who underwent 195 operations (the trial period and subsequent year). There were no deaths and follow-up was 98%. CONCLUSIONS: The ideal gastric operation based on this study emphasizes the following requirements: a small pouch (< 15 ml) totally separated from the stomach, a pouch not dependent on staples, placed in the dependent position to prevent stasis, constructed without foreign material and with an anastomosis which permits ingestion of solid food. Laparoscopic techniques have been developed for performing Roux-en-Y gastric bypass (LRYGBP) and vertical banded gastroplasty (LVBG) in patients with morbid obesity. It is not certain, however, which is the better technique in non-superobese patients (body mass index less than 50 kg/m(2)).
                Eighty-three patients (LRYGBP 37, LVBG 46) were assessed in a randomized clinical trial. Perioperative complications were recorded together with preoperative and postoperative respiratory function and mobilization rate. Patients were monitored for 2 years after operation with regard to weight change and the need for remedial surgery.
                There were no conversions to open surgery. The mean operating time was longer for LRYGBP than LVBG (138 versus 105 min). Five early reoperations were performed after LRYGBP (three for haemorrhage, one for ileus and one suspected leak) and one after LVBG (suspected leak). There were no differences in postoperative respiratory function or mobilization. Weight reduction was greater after LRYGBP (excess weight loss 78.3 versus 62.9 per cent 1 year after surgery, P = 0.009; 84.4 versus 59.8 per cent at 2 years, P < 0.001). Remedial surgical intervention was required in eight patients after LVBG (conversion to Roux-en-Ygastric bypass) and none after LRYGBP.
                LRYGBP and LVBG were comparable in terms of operative safety and postoperative recovery, but weight reduction was better after LRYGBP.
                Copyright (c) 2005 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. Observational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes.
                To determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than conventional approaches to weight loss and diabetes control.
                Unblinded randomized controlled trial conducted from December 2002 through December 2006 at the University Obesity Research Center in Australia, with general community recruitment to established treatment programs. Participants were 60 obese patients (BMI >30 and <40) with recently diagnosed (<2 years) type 2 diabetes.
                Conventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric banding with conventional diabetes care.
                Remission of type 2 diabetes (fasting glucose level <126 mg/dL [7.0 mmol/L] and glycated hemoglobin [HbA1c] value <6.2% while taking no glycemic therapy). Secondary measures included weight and components of the metabolic syndrome. Analysis was by intention-to-treat.
                Of the 60 patients enrolled, 55 (92%) completed the 2-year follow-up. Remission of type 2 diabetes was achieved by 22 (73%) in the surgical group and 4 (13%) in the conventional-therapy group. Relative risk of remission for the surgical group was 5.5 (95% confidence interval, 2.2-14.0). Surgical and conventional-therapy groups lost a mean (SD) of 20.7% (8.6%) and 1.7% (5.2%) of weight, respectively, at 2 years (P < .001). Remission of type 2 diabetes was related to weight loss (R2 = 0.46, P < .001) and lower baseline HbA1c levels (combined R2 = 0.52, P < .001). There were no serious complications in either group.
                Participants randomized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss. These results need to be confirmed in a larger, more diverse population and have long-term efficacy assessed.
                actr.org Identifier: ACTRN012605000159651. Vertical banded gastroplasty (VBG) is a frequently used surgical procedure for the treatment of morbid obesity. It can be done open (OVBG) or laparoscopic (LVBG). The aim of this double-blind randomized clinical trial was to compare the postoperative outcome and 1-year follow-up of 2 cohorts of patients who underwent either OVBG or LVBG.
                30 patients with morbid obesity were randomized into 2 groups (14 OVBG and 16 LVBG). Pain intensity, analgesic requirements, respiratory function, and physical activity were blindly analyzed during the first 3 postoperative days. Complications, weight loss, and cosmetic results after 1 year follow-up were evaluated.
                Both groups were highly comparable before surgery. Surgical time was longer in the laparoscopic procedure. Patients in this group required less analgesics during the first postoperative day. There was an earlier recovery in the expiratory and inspiratory forces, as well as faster recovery of physical activities in patients who underwent LVBG. Postoperative complications were more frequent in the open group. Excess body weight loss after 1 year was similar in both groups. Cosmetic results were significantly better in the laparoscopic group.
                LVBG had advantages over the open procedure in terms of analgesic requirements, respiratory function, postoperative recovery, and cosmetic results. Two studies were conducted to evaluate simpler, less intensive interventions for weight control which presumably would be more cost-effective and efficient than a "full-length" behavioral treatment program. In Study 1, participants in a minimal intervention (MI1) program who attended no regularly scheduled meetings and initially only received three simple verbal instructions about how to lose weight, lost an average of 11.1 lb. by 7-month follow-up. Subjects in three variations of a shortened, less intensive, 6-week behavioral weight loss program lost 7.8, 6.5 and 6.3 lb. but did not significantly differ from MI1 subjects in the amount of weight lost. In Study 2, MI2 subjects lost 5.5 lb. compared to subjects in two variations of a full-length program who lost 8.1 and 11.1 lb. by 6-month follow-up. Again, none of the groups significantly differed from each other in the amount lost. It was concluded that a minimal intervention program seems to produce weight loss and to be a cost-effective and efficient method for some subjects. The difference between the two minimal intervention programs may be related to the payment of a monetary deposit; a model for future research was presented to investigate simpler, less intensive interventions in combination with more complex ones in a "stepped-care" fashion. Laparoscopic adjustable gastric banding (LAGB) and open vertical banded gastroplasty (VBG) are treatment modalities for morbid obesity. However, few prospective randomized clinical trials (RCT) have been performed to compare both operations.
                100 patients (50 per group) were included in the study. Postoperative outcomes included hospital length of stay (LOS), complications, percent excess weight loss (%EWL), BMI and reduction in total comorbidities. Follow-up in all patients was 2 years.
                LOS was significantly shorter in the LAGB group. 3 LAGB were converted to open (1 to gastric bypass). Directly after VBG, 3 patients needed relaparotomies due to leakage, of which one (2%) died. After 2 years, 100% follow-up was achieved. BMI and %EWL were significantly decreased in both groups but significantly more in the VBG group compared to the LAGB group (31.0 kg/m2 and 70.1% vs 34.6 and 54.9% respectively). Co-morbidities significantly decreased in both groups in time. 2 years after LAGB, 20 patients needed reoperation for pouch dilation/slippage (n=12), band leakage (n=2), band erosion (n=2) and access-port problems (n=4). In the VBG group, 18 patients needed revisional surgery due to staple-line disruption (n=15), narrow outlet (n=2) or insufficient weight loss (n=1). Furthermore, 8 VBG patients developed an incisional hernia.
                This RCT demonstrates that, despite the initial better weight loss in the VBG group, based on complication rates and clinical outcome, LAGB is preferred. It had a shorter LOS and less postoperative morbidity. To perform the first prospective trial of laparoscopic versus open adjustable silicone gastric banding (ASGB) in patients with morbid obesity.
                Vertical banded gastroplasty has been used for many years to treat morbid obesity, but the size of the stoma has remained a source of failure after the procedure. ASGB has the advantages of maintaining gastric integrity and the potential for readjustment of the band, if needed. It has been suggested that laparoscopic ASGB, recently introduced to reduce postoperative complications and hospital stay, has a negative impact on outcome.
                Fifty patients with morbid obesity of >5 years' duration and a body-mass index (BMI) > 40 kg/m2 were randomized to undergo laparoscopic or open ASGB. The difficulty of the procedure, surgical time, postoperative complications, and hospital stay were assessed. Stoma adjustments, long-term complications, readmissions, weight loss, and BMI were determined.
                All procedures were successfully carried out. Of 25 patients assigned to laparoscopic ASGB, 2 were converted to an open procedure. Surgical time was significantly longer for laparoscopic ASGB (150 minutes vs. 76 minutes for open ASGB). There was no difference in complications. Mean hospital stay was 5.9 days for the laparoscopic procedure versus 7.2 days for open ASGB (p < 0.05). The total number of readmissions (6 vs. 15) and overall hospital stay in the first year (7.8 vs. 11.8 days) were lower after laparoscopic ASGB (p < 0.05). Weight and BMI were reduced significantly in both groups, but there was no difference between the groups.
                Laparoscopic and open ASGB were equally effective in terms of early (first-year) weight loss, reduction of BMI, and postoperative complications. The laparoscopic procedure was associated with a shorter initial hospital stay and fewer readmissions during follow-up and is therefore the preferred treatment in morbidly obese patients undergoing ASGB. Banded gastric bypass has been reported to result in superior weight loss compared with standard nonbanded gastric bypass. However, an adequate comparison of these procedures has not yet been reported.
                A total of 90 patients were enrolled in this prospective randomized double-blind trial comparing banded and nonbanded open gastric bypass for the treatment of super obesity. The banding technique involved placement of a 1.5 x 5.5-cm polypropylene band around the proximal gastric pouch of a standard gastric bypass procedure using the technique of Capella. Chi-square testing and analysis of variance were performed to find any differences in patient characteristics (gender, age, and initial body mass index), percentage of excess weight lost at 6, 12, 24, and 36 months postoperatively, improvement or resolution of co-morbidities, and complications in the banded versus nonbanded gastric bypass groups.
                As expected, no differences were present in the patient characteristics or incidence of co-morbidities between the banded (n = 46) and nonbanded (n = 44) groups. The body mass index, percentage of women, and mean age was 59.5 and 56.5 kg/m2, 64% and 73.8% (P = .09), and 40.6 +/- 7.4 and 42.6 +/- 7.2 years for the banded and nonbanded groups, respectively; all differences were nonsignificant. No significant differences were found in the resolution of co-morbidities. No significant difference was present in the percentage of excess weight loss at 6, 12, and 24 months (43.1% versus 24.7%, 64.0% versus 57.4%, and 64.2% versus 57.2%, respectively) postoperatively; however, the banded patients had achieved a significantly greater percentage of excess weight loss at 36 months (73.4% versus 57.7%; P <.05). The incidence of intolerance to meat and bread was greater in the banded patients. The overall number of complications was 12 (26%) in the banded and 13 (29.5%) in the nonbanded group, a nonsignficant difference. No band erosions had occurred at the last follow-up visit, and no patients in either group died.
                These results suggest that although the initial weight loss was not significantly different between the 2 groups, the banded patients continued to lose weight for < or = 3 years. The polypropylene band appeared to be well tolerated. We plan longer follow-up to confirm the possibility of additional weight loss and the prevention of weight regain in the banded group, as well as to document any long-term band complications.
Surgery is more effective than conventional management. Certain procedures produce greater weight loss, but data are limited. The evidence on safety is even less clear. Due to limited evidence and poor quality of the trials, caution is required when interpreting comparative safety and effectiveness.