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. Laparoscopic versus open gastric bypass: a randomized study of outcomes, quality of life, and costs. Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon. Effect of gastric bubble as a weight reduction device: a controlled, crossover study. Gastric Bypass and Vertical Banded Gastroplasty- a Prospective Randomized Comparison and 5-Year Follow-up. Physical and psychosocial outcome in morbidly obese patients with and without bariatric surgery: a 4 1/2-year follow-up. A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity. A randomized prospective trial of gastric bypass versus vertical banded gastroplasty for morbid obesity and their effects on sweets versus non-sweets eaters. Evidence-based postoperative pain management in nursing: is a randomized-controlled trial the most appropriate design? Web-based weight loss in primary care: a randomized controlled trial. A randomised controlled trial evaluating the use of enteral nutritional supplements postoperatively in malnourished surgical patients. Cost of in-patient care over 7 years among surgically and conventionally treated obese patients. Comparison of strategies for sustaining weight loss: the weight loss maintenance randomized controlled trial. Randomized clinical trial of hand-assisted laparoscopic versus open Roux-en-Y gastric bypass for the treatment of morbid obesity. How useful is weight reduction in the management of hypertension? Effectiveness of a behavioral weight control program for blacks and whites with NIDDM.
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. To compare outcomes, quality of life (QOL), and costs of laparoscopic and open gastric bypass (GBP).
                Laparoscopic GBP has been reported to be a safe and effective approach for the treatment of morbid obesity. The authors performed a prospective randomized trial to compare outcomes, QOL, and costs of laparoscopic GBP with those of open GBP.
                From May 1999 to March 2001, 155 patients with a body mass index (BMI) of 40 to 60 kg/m2 were randomly assigned to undergo laparoscopic (n = 79) or open (n = 76) GBP. The two groups were similar in age, sex ratio, mean BMI, and comorbidities. Main outcome measures included operative time, estimated blood loss, length of hospital stay, operative complications, percentage of excess body weight loss, and time to return to activities of daily living and work. Changes in QOL were assessed using the SF-36 Health Survey and the bariatric analysis of reporting outcome system (BAROS). Operative and hospital costs of the two operations were also compared.
                There were no deaths in either group. Mean operative time was longer for laparoscopic GBP than for open GBP, but operative blood loss was less. Two (2.5%) of the 79 patients in the laparoscopic group required conversion to laparotomy. Median length of hospital stay was shorter for laparoscopic GBP patients (3 vs 4 days). The rate of postoperative anastomotic leak was similar between groups. Wound-related complications such as infection (10.5 vs 1.3%) and incisional hernia (7.9 vs 0%) were more common after open GBP; late anastomotic stricture was less frequent after open GBP (2.6 vs 11.4%). Time to return to activities of daily living and work were shorter after laparoscopic GBP than after open GBP. Weight loss at 1 year was similar between groups. Preoperative SF-36 scores were similar between groups; however, at 1 month after surgery, laparoscopic patients had better physical conditioning, social functioning, general health, and less body pain than open GBP patients. At 6 months, the BAROS outcome was classified as good or better in 97% of laparoscopic GBP patients compared with 82% of open GBP patients. Operative costs were higher for laparoscopic GBP patients, but hospital costs were lower.
                Laparoscopic GBP is a safe and cost-effective alternative to open GBP. Despite a longer operative time, patients undergoing laparoscopic GBP benefited from less blood loss, a shorter hospital stay, and faster convalescence. Laparoscopic GBP patients had comparable weight loss at 1 year but a more rapid improvement in QOL than open GBP patients. The higher initial operative costs for laparoscopic GBP were adequately offset by the lower hospital costs. A prolonged randomized, prospective, double-blind, crossover study, including a sham-sham-treated group, was undertaken to evaluate the efficacy and safety of a 500-mL gastric bubble (Ballobes; DOT ApS, Rödovre, Denmark) as an adjunct to diet, physical training, and behavioral modification. Only supermorbidly obese patients who fulfilled the usual criteria for surgery were admitted. A weight loss of 38 kg in the first 17 weeks and another 12 kg in the second 18 weeks could be achieved. The body mass index, the percentage of overweight and the loss in percentage of initial weight, paralleled this impressive weight loss. In the second period, a plateau effect occurred after the massive changes in the first period, and only one third of the changes in all parameters was seen. Stratification into a sham-sham, sham-balloon, balloon-sham, and balloon-balloon group did not show any statistical difference for all parameters between the four groups. The double-blind nature of the study was affirmed by the patient's correct judgment of the presence or absence of a balloon in only 21% of the balloon and 44% of the sham procedures. Gastrointestinal complications were infrequent and consisted of erosions (three patients), asymptomatic reflux oesophagitis (one patient), and asymptomatic gastric ulcer (one patient). Only the latter patient had elevated gastrin levels. One patient could not tolerate the balloon. All balloons remained airtight during both parts of the study for a mean of 123 days. This study confirmed the safety of the balloon, but no additional benefit could be ascribed to the balloon compared with a very low-calorie diet and medical and dietary support. In spite of the widespread use of the Garren-Edwards gastric bubble as an adjuvant device in weight reduction, its efficacy has not been established. Therefore, our purpose was to conduct a randomized, double-blind, crossover study of this device in the management of exogenous obesity. The study group consisted of 23 patients, 21 women and 2 men, ranging in age from 21 to 53 yr. Patients were 25%-111% above their ideal body weight. They were studied for 24 wk, consisting of two separate 12-wk evaluation periods. Patients were randomly assigned either to receive the gastric bubble or to have a sham procedure. After the first 12-wk evaluation period, the gastric bubble and sham were administered in crossover fashion, so that those who had received the gastric bubble initially received the sham later and vice versa. The study coordinator remained blind to the kind of treatment, weighed each patient biweekly, enforced dietary counseling, and provided behavior modification. Those who had passed or were found to have a deflated bubble at the end of the treatment period were excluded from the study. Mean weight reduction in the two evaluation periods did not differ significantly. Patients lost 5.4 +/- 1.7 kg (mean +/- SE) during the gastric bubble period and 5.20 +/- 0.8 kg during the sham period. The order of administration of the gastric bubble and sham did not significantly affect the result. The time-course of mean biweekly values, however, revealed that with the gastric bubble, weight loss was significantly greater only during first (p less than 0.005) and second (p less than 0.025) 2-wk evaluation periods. This difference, however, disappeared after the initial 4 wk of treatment. These observations suggest that although gastric bubble implantation reduced weight significantly more than the sham procedure initially, the mean weight loss during 12 wk of evaluation was not different between the two periods. In our opinion, the gastric bubble is of no value as an adjuvant device in weight reduction. BACKGROUND: a prospective randomized study was undertaken to compare the outcome of vertical banded gastroplasty (VBG) and gastric bypass (GBP) in patients with clinically severe obesity. METHODS: eligibility criteria included Class IV obesity, < 50 years old and a history of at least one attempt of non-operative weight loss. Patients were managed conservatively for 3 months prior to surgery. Patients were followed post-operatively and monitored for early and late complications and their weight loss outcome for up to 5 years. RESULTS: 44 patients were recruited. Two patients withdrew within 4 weeks and were excluded. Twenty subjects had a GBP and 22 a VBG. There were no significant differences with respect to age, gender, maximum or pre-operative weight between the groups (p > 0.05). Patients who underwent GBP demonstrated significantly greater post-operative weight loss (p < 0.05) which was apparent from 6 months onwards. There were no deaths, pulmonary emboli, post-operative leaks or wound dehiscence. There were no instances of staple-line disruption. Symptomatic ulcer disease, confirmed endoscopically, developed in 25% of GBP patients. Nine patients developed gallstones post-operatively of whom five were in the VBG and four in the GBP group. CONCLUSIONS: weight loss following GBP was maintained, while VBG patients slowly regained. Morbidly obese patients show high somatic and psychiatric co-morbidity. Bariatric surgery is accepted as the obesity treatment with the greatest long-term success. There is growing evidence that follow-up studies should address somatic as well as psychosocial conditions of patients undergoing bariatric surgery and non-operatively treated patients. This study investigates the physical and psychosocial outcomes of patients with and without bariatric surgery.
                A sample of 131 morbidly obese patients applying for bariatric surgery underwent somatic and psychological assessment (T0). A first follow-up study (T1) was conducted 2 years after T0 in 119 patients. The present second follow-up (T2) was carried out 4 1/2 years after T0 and 3.2 years after potential bariatric surgery. Psychological/psychosocial measures were collected in the 93 patients, 63 of whom were treated surgically, via the Psychosocial Stress and Symptom Questionnaire (PSSQ) and a telephone interview covering BMI, employability, medication, doctor consultations, eating behavior, and physical/psychological well-being.
                Patients with and without bariatric surgery showed a BMI reduction, which was significantly greater in those who underwent surgery (P<.001). The average percentage of excess weight loss (%EWL) between T0 and T2 was 11.5% in patients with no bariatric surgery, 36.0% in patients with laparoscopic gastric banding, and 52.8% in patients with laparoscopic gastric bypass (%EWL between T0 and T2 in patients of all groups significant, P<.001). Patients with and without surgical treatment showed significant improvement with regard to depressive symptoms and binge-eating behavior. Three-quarters of the surgically-treated and two-thirds of the non-treated patients rated their physical, psychological, and psychosocial well-being as "good" at T2.
                After 3 to 4 years, all of the patients have adapted well to their weight and body appearance, regardless of whether they have undergone surgery. Weight loss is, however, greater for operated patients, which strongly decreases the risk of developing obesity-related co-morbidities. We investigated the effect of an endoscopically placed gastric balloon, the Garren-Edwards gastric bubble (GEGB), on weight loss in obese patients. Fifty-nine obese patients were entered into a prospective double-blind study and randomized into two groups. In one group (34 patients) the GEGB was inserted, and in the other group (25 patients) a sham insertion was done. All patients participated in a standard weight loss program consisting of dietary therapy, behavior modification, and physical exercise. The bubble was removed endoscopically after 3 months from both groups. Patients were followed for an additional 9 months after bubble removal and weight loss was monitored. Weight loss was the same in both groups at 3 months (18.7 lb vs. 17.2 lb). This was true whether determined by change in pounds, percentage of body weight, or body mass index. We concluded that the GEGB was of no added benefit as compared with sham insertion, when combined with a standard weight loss program. Because of the lack of proven efficacy and the relatively high cost, we recommend that such devices be restricted to controlled studies until significant benefits are proven. Vertical banded gastroplasty (VBGP) was compared with Roux-en-Y gastric bypass (RYGBP) in a randomized prospective trial that included preoperative dietary separation of "sweets eaters" versus "non-sweets eaters." Randomization was stopped at 9 months after 20 patients had undergone each procedure because a greater weight loss (p less than 0.05) was noted after RYGBP than VBGP. This difference became more significant (p less than 0.001) at each 3-month interval through 3 years, when patients who had VBGPs had lost 37 +/- 20% of excess weight compared with 64 +/- 19% for patients who had RYGBPs. The members of the groups were comparable with regard to age, sex, eating habits, morbidity rates before surgery, ideal body weight, and weight before surgery. Although there was no significant difference between the loss of excess weight in "sweets eaters" (69 +/- 17%) or "non-sweets eaters" (67 +/- 17%) after RYGBP at 1 year, "sweets eaters" who had VBGPs lost significantly less excess weight (36 +/- 13%) than did "non-sweets eaters" who had VBGPs (57 +/- 18%), p less than 0.02, or "sweets eaters" who had RYGBPs, p less than 0.0001. No significant differences were noted for electrolytes, renal or liver function tests, and most vitamins between patients who had VBGPs and RYGBPs; however, patients who had RYGBPs had lower (p less than 0.05) serum vitamin B12 levels (286 +/- 149 pg/dl) than did patients who had VBGPs (461 +/- 226 pg/dl) at 2 years. By 3 years, the vitamin B12 levels were equal in members of the two groups. Five patients who had RYGBPs required endoscopic stomal dilatation for stomal stenosis and one had a marginal ulcer develop, which responded to cimetidine. RYGBP was clearly superior to VBGP for "sweets eaters," probably because of the development of dumping syndrome symptoms. However, RYGBP was associated with a larger number of correctable problems. Thus, it is important to evaluate a patient's eating habits before surgery for morbid obesity; "non-sweets eaters" probably should be treated with VBGP and "sweets eaters" with RYGBP. There is an increasing drive to make nursing care evidence-based. High quality evidence from systematic reviews relevant to postoperative pain relief exists, yet pain after surgery remains poorly controlled for many patients. This study aimed to assess whether implementing evidence-based pain management improved postoperative pain outcomes. Pain on a 0-10 scale was the primary outcome and analgesic consumption a secondary outcome. A baseline audit was undertaken on four surgical wards to establish whether there was a need for the study. A randomized-controlled trial was then designed to assess the effects of implementing an evidence-based approach to postoperative pain management. The four wards were randomized to receive the intervention or act as a control. Outcomes were assessed 3 months after the intervention on both intervention and control wards. The intervention (implementation of an oral analgesic algorithm derived from systematic reviews) was then implemented on the control wards and outcomes reassessed after 3 months on the control wards. The intervention was designed using an evidence-based approach to effective implementation. Four interactive sessions covered: (1) detailed feedback of baseline data and discussion (utilizing audit and feedback), (2) why systematic reviews, analgesic league tables and choice of drugs to develop an analgesic algorithm (see Figure 1), (3) principles of evidence based health care (EBHC), including critical appraisal and (4) facilitation and change workshop. The findings revealed no significant differences in pain level or drug use between the intervention and control wards. However, the control wards also changed during the control period. Possible explanations for this are discussed. When looking at changes compared with baseline, both intervention and control wards increased their use of algorithm drugs and reduced use of non-algorithm drugs during the study. No effects were found on pain in the intervention wards. Pain ratings at rest since surgery, on movement since surgery and worst pain on movement were significantly reduced compared with baseline in the control wards. Although there are many pressures to utilize a randomized-controlled trial study design in the culture of evidence-based health care, there will be times, especially when implementing complex changes in practice that other types of design should be considered. Evidence is lacking regarding effective and sustainable weight loss approaches for use in the primary care setting. We conducted a 12-week randomized controlled trial to evaluate the short-term efficacy of a web-based weight loss intervention among 101 primary care patients with obesity and hypertension. Patients had access to a comprehensive website that used a moderate-intensity weight loss approach designed specifically for web-based implementation. Patients also participated in four (two in-person and two telephonic) counseling sessions with a health coach. Intent-to-treat analysis showed greater weight loss at 3 months (-2.56 kg; 95% CI -3.60, -1.53) among intervention participants (-2.28 +/- 3.21 kg), relative to usual care (0.28 +/- 1.87 kg). Similar findings were observed among intervention completers (-3.05 kg; 95% CI -4.24, -1.85). High rates of participant retention (84%) and website utilization were observed, with the greatest weight loss found among those with a high frequency of website logins (quartile 4 vs. 1: -4.16 kg; 95% CI -1.47, -6.84). The intervention's approach promoted moderate weight loss at 12 weeks, though greater weight loss was observed among those with higher levels of website utilization. Efficacious web-based weight loss interventions can be successfully offered in the primary care setting. Patients who undergo surgery are at risk of malnutrition due to periods of starvation, the stress of surgery, and subsequent increase in metabolic rate. There are limited data on nutritional outcome of surgical patients.
                To investigate changes in nutritional status and the influence of oral supplements on nutritional status, morbidity, and quality of life in postoperative surgical patients.
                Entry was determined by the presence of malnutrition, as defined by a body mass index (BMI) < or =20 kg/m(2), anthropometric measurements < or =15th percentile on admission, or initiation of oral diet postoperatively and/or a weight loss of 5% or more during the operative period. We studied 101 patients: 52 were randomised to the treatment group (TG) and prescribed a 1.5 kcal/ml nutritional supplement; 49 patients were randomised to the control group (CG) and continued with routine nutritional management. Nutritional status was assessed by weight, anthropometry, and grip strength, with measurements taken at two weekly intervals for 10 weeks. Complications, namely wound infection, chest infection, and antibiotic use were documented. Quality of life (QOL) was assessed using the UK SF-36 questionnaire.
                Patients in the control group lost a maximum mean (SD) of 5.96 (4.21) kg in weight over a period of eight weeks while patients in group TG lost less weight overall (maximum mean (SD) 3.40 (0.89) kg (p<0.001) occurring at four weeks and progressively regained weight from week 4). Anthropometry, grip strength, and QOL were similarly significantly different between groups (p<0.001). Fewer patients in the treatment group (7/52) required antibiotic prescriptions compared with the control group (15/49).
                Nutritional status declined for two months after discharge. Postoperative nutritional supplementation improved nutritional status, QOL, and morbidity in these patients. Bariatric surgery improves cardiovascular risk factors and quality of life, but few studies have directly addressed the relation between obesity treatment and hospitalization costs. This prospective controlled study compares in-patient care between surgically and conventionally treated obese patients.
                A total of 962 surgically and conventionally treated obese patients from the intervention study, Swedish Obese Subjects, were followed for 6 years. Changes in days of hospitalization and hospitalization costs were analyzed. Information on hospitalizations for each subject were obtained from the Swedish Hospital Discharge Register.
                After 6 years, weight change was -16.7% in the surgical group and +0.9% in the control group (p < 0.0001). The cumulated hospital stay over 6 years was 23.4 days in the surgical group and 6.9 days in the control group (p < 0.0001). The average hospital cost for the surgical intervention was US$4300. Incremental costs that could be attributable to obesity surgery averaged US$1200 per year. After exclusion of hospitalizations for the surgical intervention and conditions common after bariatric surgery, there were no significant differences between the groups in number of hospital days or hospitalization costs.
                Our experience from bariatric surgery indicates that average weight reductions of 16% will not reduce hospitalization costs over 6 years. Costs of bariatric surgery are limited and seem to be motivated given the marked improvements of cardiovascular risk factors, cardiac structure, and function and health-related quality of life. Behavioral weight loss interventions achieve short-term success, but re-gain is common.
                To compare 2 weight loss maintenance interventions with a self-directed control group.
                Two-phase trial in which 1032 overweight or obese adults (38% African American, 63% women) with hypertension, dyslipidemia, or both who had lost at least 4 kg during a 6-month weight loss program (phase 1) were randomized to a weight-loss maintenance intervention (phase 2). Enrollment at 4 academic centers occurred August 2003-July 2004 and randomization, February-December 2004. Data collection was completed in June 2007.
                After the phase 1 weight-loss program, participants were randomized to one of the following groups for 30 months: monthly personal contact, unlimited access to an interactive technology-based intervention, or self-directed control. Main Outcome Changes in weight from randomization.
                Mean entry weight was 96.7 kg. During the initial 6-month program, mean weight loss was 8.5 kg. After randomization, weight regain occurred. Participants in the personal-contact group regained less weight (4.0 kg) than those in the self-directed group (5.5 kg; mean difference at 30 months, -1.5 kg; 95% confidence interval [CI], -2.4 to -0.6 kg; P = .001). At 30 months, weight regain did not differ between the interactive technology-based (5.2 kg) and self-directed groups (5.5 kg; mean difference -0.3 kg; 95% CI, -1.2 to 0.6 kg; P = .51); however, weight regain was lower in the interactive technology-based than in the self-directed group at 18 months (mean difference, -1.1 kg; 95% CI, -1.9 to -0.4 kg; P = .003) and at 24 months (mean difference, -0.9 kg; 95% CI, -1.7 to -0.02 kg; P = .04). At 30 months, the difference between the personal-contact and interactive technology-based group was -1.2 kg (95% CI -2.1 to -0.3; P = .008). Effects did not differ significantly by sex, race, age, and body mass index subgroups. Overall, 71% of study participants remained below entry weight.
                The majority of individuals who successfully completed an initial behavioral weight loss program maintained a weight below their initial level. Monthly brief personal contact provided modest benefit in sustaining weight loss, whereas an interactive technology-based intervention provided early but transient benefit.
                clinicaltrials.gov Identifier: NCT00054925. : Roux-en-Y gastric bypass (RYGBP) has increased in popularity since the introduction of the laparoscopic procedure, but this approach requires extensive surgical skill and the learning curve is steep. The present study examined the suitability of hand-assisted laparoscopy for RYGBP.
                In a prospective trial, 50 patients (median age 38 years, body mass index 45 kg/m(2)) were randomized to either hand-assisted (n = 25) or open (n = 25) RYGBP. The hand-assisted device was introduced through a right subcostal incision. Laparoscopic staplers were also used in the open group, allowing a short upper midline incision. The gastrojejunostomy was made by means of a circular stapler and the Roux limb placed behind the colon and excluded stomach.
                The postoperative outcome, with respect to morphine consumption, complications, hospital stay (6 days) and weight loss, was similar in the two groups. The operating time was significantly longer in the hand-assisted group (150 versus 85 min; P < 0.001) but there was no conversion to open operation. One patient in the hand-assisted group was reoperated owing to leakage and one patient developed an incisional hernia after open RYGBP.
                The hand-assisted technique was feasible and allowed good working conditions in all patients. However, the postoperative outcome was excellent in both groups and there was no advantage to the hand-assisted technique.
                Copyright 2004 British Journal of Surgery Society Ltd. A group of previously untreated obese hypertensive patients were started on a weight reduction programme supervised by two dietitians working in a general practice surgery. It was stressed from the beginning of the programme that reducing blood pressure was the purpose of the diet. The results of follow-up after six months are presented together with results for a control group of obese hypertensive patients not receiving dietary advice or drug therapy, but being followed by the general practitioner. The weight, systolic blood pressure and diastolic blood pressure of the dieting hypertensive group were significantly lower than those of the non-dieting group after six months. However, the drop-out rate was significantly higher for the dieting group than for the non-dieting group.The results of a separate comparison between a control group of obese normotensive patients following the same dietary programme and the group of dieting obese hypertensive patients are also presented. Attendance rates and weight loss achieved were significantly better for the hypertensive group than for the normotensive group after 12 months.Weight reduction appears to be an effective first-line therapy for approximately 50% of obese patients with mild to moderate hypertension, and raised blood pressure appears to provide motivation for such patients to attend a dietitian's clinic and to lose weight. To compare the weight losses of black and white patients with NIDDM treated in a year-long behavioral weight loss program.
                Subjects were randomly assigned to a behavioral program that either used a low-calorie diet throughout or included two 12-week periods of a very-low calorie diet (VLCD). Weight, dietary intake, and exercise were measured at 0, 6, and 12 months of treatment, and attendance and self-monitoring records were assessed weekly throughout the year.
                Blacks had smaller weight losses than whites regardless of treatment condition. Overall weight losses (baseline to 1 year) were 7.1 kg in blacks vs 13.9 kg in whites. The differences in overall outcome resulted primarily from greater weight regain in blacks during months 6-12 than in whites. There was a trend for blacks to have poorer attendance than whites during the latter half of the program and for blacks to report smaller changes in calorie intake from baseline to 6 months.
                The results confirm prior studies with nondiabetic patients showing smaller weight losses in blacks than in whites and suggest that these differences may result primarily from faster weight regain in blacks. Further research is needed to more carefully examine the variables that may explain this difference and to develop more effective programs for blacks with NIDDM.
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.