Changes in Outcomes, Satiety and Adverse Upper Gastrointestinal Symptoms Following Laparoscopic Adjustable Gastric Banding.

BACKGROUND: Patient-reported outcomes and perceptions are critical to the overall efficacy and acceptability of a surgical procedure. Outcomes, such as patient satisfaction and perceived success of the surgery and adverse symptoms, have not been described in detail following bariatric surgery. The associations and predictors of patient satisfaction have not been defined. This study aimed to examine long-term outcomes and perceptions after laparoscopic adjustable gastric banding (LAGB). METHODS: We conducted a prospective study of outcomes, satiety and adverse upper gastrointestinal symptoms, as well as quality of life and subjective patient satisfaction in LAGB patients. Data were collected at 3 years (T1) and 8 years post-operatively (T2). RESULTS: One-hundred and sixty patients completed follow-up at T1 and T2. The average age was 44.0 ± 11.2 years. At T2, the total body weight loss was 17.8 ± 11.9 %. Satisfaction decreased significantly between time points (8.6 ± 1.8 vs 7.2 ± 2.9, p < 0.01), and quality of life reduced slightly across all domains. Hunger scores remained low (3.8 ± 1.8 vs 3.9 ± 1.8, p = 0.61). The dysphagia score did not change significantly (p = 0.54). There was minimal change in frequency of regurgitation, although there was significant increase in patient assessment of how bothered they were by regurgitation. Multivariate analysis identified increased awareness of regurgitation as a principal driver of reduced satisfaction. CONCLUSIONS: Weight loss, satiety and adverse symptoms demonstrated only slight changes between 3 and 8 years post-operatively. Despite this, overall satisfaction and perception of success of the procedure reduced markedly. This appeared mediated by reduced tolerance of adverse symptoms. These data inform follow-up practises aimed at optimizing outcomes.

The Effect of Weight Loss on Indigenous Australians with Diabetes: a study of Feasibility, Acceptability and Effectiveness of Laparoscopic Adjustable Gastric Banding.

BACKGROUND/OBJECTIVES: Diabetes and obesity are common and serious health challenges for indigenous people worldwide. The feasibility of achieving substantial weight loss, leading to remission of diabetes, was evaluated in a regional indigenous Australian community. SUBJECTS/METHODS: A prospective cohort study of 30 obese indigenous adults from the Rumbalara Aboriginal Co-operative in Central Victoria was performed. Inclusion criteria included aboriginality, BMI > 30 kg/m(2) and diabetes diagnosed within the last 10 years. Weight loss was achieved using laparoscopic adjustable gastric banding (LAGB). Participants were treated in their community and followed for 2 years. Outcomes were compared with those of non-indigenous Australians from an earlier randomized controlled trial (RCT) using a similar protocol. RESULTS: 30 participants (26 females, mean age 44.6 years; mean BMI 44.3) had LAGB at the regional hospital. Twenty-six participants completed diabetes assessment at 2 years follow-up. They showed diabetes remission (fasting blood glucose < 7.0 mmol/L and haemoglobin A1c (HbA1c) < 6.2 % while off all therapy except metformin) in 20 of the 26 and a mean weight loss (SD) of 26.0 (14) kilograms. Based on intention-to-treat, remission rate was 66 %. Quality of life improved. There was one early event and 12 late adverse events. The outcomes for weight loss and diabetes remission were not different from the LAGB group of the RCT. CONCLUSIONS: For obese indigenous people with diabetes, a regionalized model of care centred on the LAGB is an effective approach to a serious health problem. The model proved feasible and acceptable to the indigenous people. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN 12609000319279).

Concurrent Large Para-oesophageal Hiatal Hernia Repair and Laparoscopic Adjustable Gastric Banding: Results from 5-year Follow Up.

OBJECTIVE: The objective of the study is to identify the efficacy and safety of combining laparoscopic adjustable gastric banding with repair of large para-oesophageal hernias. BACKGROUND: Para-oesophageal hernias are more common in the obese with higher recurrence rates following repair. The effect and safety of combining para-oesophageal hernia repair with laparoscopic adjustable gastric banding is unknown. METHODS: One-hundred fourteen consecutive patients undergoing primary laparoscopic adjustable gastric banding with concurrent repair of a large para-oesophageal hernia were prospectively identified and matched to a control group undergoing primary laparoscopic adjustable gastric banding only. Weight loss and complication data were retrieved from a prospectively maintained database, and a standardised bariatric outcome questionnaire was used to assess post-operative symptoms, satisfaction with surgery and satiety scores. RESULTS: At a mean follow up of 4.9 ± 2.1 years, total weight loss was 16.4 ± 9.9% in the hernia repair group and 17.6 ± 12.6% in the control group (p = 0.949), with 17 vs. 11% loss to follow up rates (p = 0.246). No statistically significant difference in revisional surgery rate and symptomatic recurrence of hiatal hernia was documented in four patients in the hernia repair group (3.5%). No statistically significant difference in mean reflux (9.9 vs. 10.3, p = 0.821), dysphagia (20.7 vs. 20.1, p = 0.630) or satiety scores was identified. CONCLUSIONS: Concurrent repair of large para-oesophageal hiatal hernia and laparoscopic adjustable gastric banding placement is safe and effective both in terms of symptom control and weight loss over the intermediate term. In obese patients with large hiatal hernias, consideration should be given to combining repair of the hernia with a bariatric procedure.

Pre-operative weight loss does not predict weight loss following laparoscopic adjustable gastric banding.

BACKGROUND: This study aimed to test the hypothesis that the amount of weight lost on a mandatory 2-week pre-operative very-low-calorie diet (VLCD) would predict the longer-term outcomes of laparoscopic adjustable gastric banding (LAGB). METHODS: All patients treated with a primary LAGB from 21 October 2008 until 30 June 2010, who were prescribed a 2-week pre-operative VLCD, have been included in the study. Patient age, weight, BMI and excess weight (defined as weight above a BMI of 25) were extracted on the day of first visit, day of surgery and at the post-operative visits at 3, 12 and 24 months. From these data, percent excess weight loss (EWL) was calculated and compared at all time points. RESULTS: The weight loss achieved on a mandatory 2-week pre-operative diet did not predict weight outcomes at 2 years (r = -0.008; p = 0.931). Using multivariate analysis, the best predictor of 24-month percent EWL was percent EWL at 3 months post operation (sr(2) = 0.34; p = 0.003). CONCLUSIONS: Results from a pre-operative diet should not be used to predict the ultimate outcome of bariatric surgery. The weight loss at 3 months following LAGB was a strong predictor of longer-term outcomes. There may be potential for improving longer-term results with LAGB by better supporting patients who are not achieving good weight loss at this early time point.

Erosions after laparoscopic adjustable gastric banding: diagnosis and management.

OBJECTIVE: To define the changing prevalence of erosion after Laparoscopic Adjustable Gastric Banding (LAGB), describing the range of clinical presentations, the approaches to treatment and the outcomes from these approaches over a 15-year study period. BACKGROUND: A recent systematic review of the literature of erosion after LAGB identified 25 relevant studies and reported a total of 231 erosions in 15,775 patients giving an overall incidence of 1.46%. The review highlighted a broad variation of incidence from 0.2% to 33%. The review was unable to identify either common presentations or an optimal pattern of management. METHODS: Patients who underwent a primary LAGB operation between September 1994 and January 2010 by 2 surgeons (P.O.B. and W.B.) were identified in a prospectively maintained database. Those patients who had an erosion of their LAGB were identified. Presentation, operative details, demographics, body mass index, weight history, and perioperative problems were analyzed. RESULTS: In total, 2986 patients were identified. All bands placed were Lap-Bands (Allergan, CA). Hundred erosions were experienced by 85 patients (2.85%) at a median time of 33 months from initial surgery to the erosion (range: 11-170 months). The rate of erosion was highest when the band was placed by the perigastric approach at 6.77%. Since the adoption of the pars flaccida approach, the rate of erosion has dropped to 1.07%. The majority of patients who had experienced an erosion (71 patients; 83.5%) experienced only 1 erosion, 13 patients (15.3%) had 2 erosions, and 1 patient had 3 erosions. The most common presentation was loss of satiety. The band has been successfully replaced in 56 patients. It has been explanted in 27 patients and 2 patients were converted to other bariatric procedures. The weight loss in patients who had a LAGB reinserted after erosion was not significantly different to the background cohort. CONCLUSIONS: Erosion of LAGB is uncommon and its clinical course is benign. It is best treated with a staged surgical approach; initially, with removal and repair followed later by replacement. With this approach, weight loss is maintained and reerosion is uncommon.

Long-term outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature.

OBJECTIVE: To describe the long-term outcomes after laparoscopic adjustable gastric banding (LAGB) and compare these with the published literature on bariatric surgery. BACKGROUND: Because obesity is a chronic disease, any proposed obesity treatment should be expected to demonstrate long-term durability to be considered effective. Yet for bariatric surgery, few long-term weight loss data are available. We report our 15-year follow-up data after LAGB and provide a systematic review of the peer-reviewed literature for weight loss at 10 years or more after bariatric surgical procedures. METHODS: We performed a prospective longitudinal cohort study of LAGB patients using an electronic database system (LapBase) to track progress, measure weight changes, and document revisional procedures. The evolution of the LAGB procedure was recognized, and revisional rates for 3 separate periods between September 1994 and December 2011 were described. In addition, we performed a systematic review of the peer-reviewed published literature collecting all reports that included weight loss data at or beyond 10 years. RESULTS: A total of 3227 patients, with a mean age of 47 years and a mean body mass index of 43.8 kg/m, were treated by laparoscopic adjustable gastric band placement between September 1994 and December 2011. Seven hundred fourteen patients had completed at least 10 years of follow-up. Follow-up was intact in 81% of patients overall and 78% of those beyond 10 years. There was no perioperative mortality for the primary placement or for any revisional procedures. There was 47.1% of excess weight loss (% EWL) at 15 years [n = 54; 95% confidence interval (CI) = 8.3] and 62% EWL at 16 years (n = 14; 95% CI = 13.6). There was a mean of 47.0% EWL (n = 714; 95% CI = 1.3) for all patients who were at or beyond 10 years follow-up. Revisional procedures were performed for proximal enlargement (26%), erosion (3.4%), and port and tubing problems (21%). The band was explanted in 5.6%. The need for revision decreased as the technique evolved, with 40% revision rate for proximal gastric enlargements in the first 10 years, reducing to 6.4% in the past 5 years. The revision group showed a similar weight loss to the overall group beyond 10 years. The systematic review of all bariatric procedures with 10 or more years of follow-up showed greater than 50% EWL for all current procedures. The weighted mean at maximum follow-up for LAGB was 54.2% EWL and for Roux-en-Y gastric bypass was 54.0% EWL. CONCLUSIONS: The LAGB study from 1 center demonstrates a durable weight loss with 47% EWL maintained to 15 years. This weight loss occurred regardless of whether any revisional procedures were needed. A systematic review shows substantial and similar long-term weight losses for LAGB and other bariatric procedures.

Eradication of disseminated adenovirus infection in a pediatric hematopoietic stem cell transplantation recipient using the novel antiviral agent CMX001.

Adenovirus infection is a serious and often fatal complication in hematopoietic stem cell transplant patients. There are currently no FDA-approved therapies for adenovirus infection, with only anecdotal, off-label uses described for a variety of anti-viral agents or immune therapies. We report the first case of successful eradication of disseminated adenovirus infection by the novel antiviral agent CMX001 in a severely immunocompromised pediatric stem cell transplant recipient following failure to respond to intravenous cidofovir. Complete clinical and virologic response was documented; virologic and pharmacokinetic data are reported. CMX001 is a promising new oral antiviral agent under development for the prophylaxis and treatment of severe infections caused by double-stranded DNA viruses including adenovirus in immunocompromised patients.

Outcomes, satiety, and adverse upper gastrointestinal symptoms following laparoscopic adjustable gastric banding.

BACKGROUND: Follow-up is critical to the success of laparoscopic adjustable gastric banding (LAGB). Few data guide this and expected norms of satiety, adverse symptoms, and outcomes have not been defined. METHODS: Consecutive patients, who underwent LAGB, were evaluated using a newly developed instrument that assessed satiety, adverse upper gastrointestinal (dysphagia, reflux, and epigastric pain), and outcomes (overall satisfaction, weight loss, and quality of life (SF-36)). RESULTS: Three hundred twenty-three of 408 patients responded (80%; mean age 44.4 ± 11.8 years, 56 males). Excess weight loss was 52%. Satiety was greater at breakfast compared to lunch (5.3 ± 1.9 vs. 4.1 ± 1.7, p < 0.005) or dinner (3.8 ± 1.8, p < 0.005). The satisfaction score was 8.3 ± 2.1 out of 10, and 91% would have the surgery again. Quality of life was less than community norms, except in physical functioning (83.4 ± 20.5 vs. 84.7 ± 22.0, p = 0.25) and bodily pain (78.4 ± 15.2 vs. 75.9 ± 25.3, p = 0.004). Inability to consume certain foods was cited as the biggest problem by 66% of respondents. The dysphagia score was 19.9 ± 8.7; softer foods were tolerated, although difficulty was noted with firmer foods. The reflux score was 8.7 ± 9.8 and regurgitation occurred a mean of once per week. Weight loss and the mental component score were the only predictors of overall satisfaction (r² = 0.46, p = 0.01). CONCLUSIONS: Patients are highly satisfied with the outcome of LAGB and achieve substantial weight after 3 years. Expected ranges of satiety, adverse symptoms, and outcomes have been defined. The most troublesome symptom is the inability to consume certain foods. Weight loss predicted overall satisfaction, regardless of adverse symptoms.

Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial.

CONTEXT: Adolescent obesity is a common and serious health problem affecting more than 5 million young people in the United States alone. Bariatric surgery is being evaluated as a possible treatment option. Laparoscopic adjustable gastric banding (gastric banding) has the potential to provide a safe and effective treatment. OBJECTIVE: To compare the outcomes of gastric banding with an optimal lifestyle program on adolescent obesity. DESIGN, SETTING, AND PATIENTS: A prospective, randomized controlled trial of 50 adolescents between 14 and 18 years with a body mass index (BMI) higher than 35, recruited from the Melbourne, Australia, community, assigned either to a supervised lifestyle intervention or to undergo gastric banding, and followed up for 2 years. The study was performed between May 2005 and September 2008. MAIN OUTCOME MEASURES: Weight loss. Secondary outcomes included change in metabolic syndrome, insulin resistance, quality of life, and adverse outcomes. RESULTS: Twenty-four of 25 patients in the gastric banding group and 18 of 25 in lifestyle group completed the study. Twenty-one (84%) in the gastric banding and 3 (12%) in the lifestyle groups lost more than 50% of excess weight, corrected for age. Overall, the mean changes in the gastric banding group were a weight loss of 34.6 kg (95% CI, 30.2-39.0), representing an excess weight loss of 78.8% (95% CI, 66.6%-91.0%), 12.7 BMI units (95% CI, 11.3-14.2), and a BMI z score change from 2.39 (95% CI, 2.05-2.73) to 1.32 (95% CI, 0.98-1.66). The mean losses in the lifestyle group were 3.0 kg (95% CI, 2.1-8.1), representing excess weight loss of 13.2% (95% CI, 2.6%-21.0%), 1.3 BMI units (95% CI, 0.4-2.9), and a BMI z score change from 2.41 (95% CI, 2.21-2.66) to 2.26 (95% CI, 1.91-2.43). At entry, 9 participants (36%) in the gastric banding group and 10 (40%) in the lifestyle group had the metabolic syndrome. At 24 months, none of the gastric banding group had the metabolic syndrome (P = .008; McNemar chi(2)) compared with 4 of the 18 completers (22%) in the lifestyle group (P = .13). The gastric banding group experienced improved quality of life with no perioperative adverse events. However, 8 operations (33%) were required in 7 patients for revisional procedures either for proximal pouch dilatation or tubing injury during follow-up. CONCLUSIONS: Among obese adolescent participants, use of gastric banding compared with lifestyle intervention resulted in a greater percentage achieving a loss of 50% of excess weight, corrected for age. There were associated benefits to health and quality of life. TRIAL REGISTRATION: ANZCTR Identifier: 12605000160639.

Motivation, readiness to change, and weight loss following adjustable gastric band surgery.

High levels of readiness to change (RTC) are considered critical to the long-term success of weight management programs including bariatric surgery. However, there are no data to support this assertion. We hypothesize that RTC level will not influence weight outcomes following surgery. In 227 consecutive patients undergoing adjustable gastric banding surgery, we recorded reasons for seeking surgery, and RTC measured with the University of Rhode Island Change Assessment. Scores were blinded until study completion. The primary outcome measure was percentage of excess BMI loss at 2 years (%EBMIL-2); others included compliance and surgical complications. Of 227 subjects, 204 (90%) had weight measurement at 2 years. There was no significant correlation between RTC score and %EBMIL-2 (r = 0.047, P = 0.5). Using the median split for RTC score the lowest 102 subjects mean %EBMIL-2 was 52.9 +/- 26.9% and the highest 52.2 +/- 28.3%, P = 0.869. There was no weight loss difference between highest and lowest quartiles, or a nonlinear relationship between weight loss and RTC score. There was no significant relationship between RCT score and compliance, or likelihood of complications. Those motivated by appearance were more likely to be younger women who lost more weight at 2 years. Poor attendance at follow-up visits was associated with less weight loss, especially in men. Measures of RTC did not predict weight loss, compliance, or surgical complications. Caution is advised when using assessments of RTC to predict outcomes of bariatric surgery.

Raised CRP levels in obese patients: symptoms of depression have an independent positive association.

BACKGROUND: Depression and obesity, the two common ailments of modern society, are associated with increased risk of coronary artery disease and raised C-reactive protein (CRP) levels. Are the effects of depression and obesity related or do they influence CRP levels independently? OBJECTIVE: In 493 consecutive patients presenting for obesity surgery, we explored the relationship between symptoms of depression and raised CRP levels after controlling for confounding factors. METHODS AND PROCEDURES: Depression was measured using the Beck Depression Inventory (BDI). Confounding variables were age, gender, BMI, waist and hip measures, smoking and alcohol habits, medications, biochemical measures of the metabolic syndrome, and indirect measures of insulin resistance. General linear regression sought variables independently associated with CRP levels. RESULTS: These patients had a BMI range from 31 to 91 kg/m2, participants age ranged from 14 to 71 years, and 76% were women. The median CRP concentration was 7.7mg/l (interquartile range: 3.9-14), 40% had an abnormally raised concentration (> 10mg/l). The mean BDI score was 17.0 +/- 9.0, indicating symptoms of moderate depression. We found five independent factors associated with raised CRP levels. In order of strength of association, these were: higher BMI (beta = 0.36, P < 0.001), female gender (beta = -0.19, P < 0.001), estrogen therapy (beta = 0.18, P < 0.001), higher BDI score (beta = 0.11, P = 0.01), and insulin resistance index (beta = 0.11, P = 0.01), and with a combined R2 = 0.24, (P < 0.001). DISCUSSION: In obese patients, symptoms of depression were associated with raised CRP levels after controlling for confounding variables. Obese women on estrogen therapy are at risk of high CRP levels.

Symmetrical pouch dilatation after laparoscopic adjustable gastric banding: incidence and management.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) has commonly been complicated by the problem of band slippage or prolapse. Since popularization of the pars flaccida approach and improved anterior fixation, it is our impression that the problem of symmetrical dilatation of the proximal gastric pouch has become more important. METHODS: We have reviewed the results of a series of 425 LAGB all performed by the pars flaccida approach from June 2003 to October 2007 to analyze the incidence and implications of this new pattern. RESULTS: There were no posterior prolapses, 2 anterior prolapses, and 17 cases of symmetrical pouch dilatation (SPD) (revision rate 4.4%). Teenage patients had a 22% revision rate for SPD. All revisions were completed laparoscopically with no mortality, no significant complications, and a median hospital stay of 1 day. The median weight loss following revisional surgery was not significantly different from the background cohort. CONCLUSION: SPD is the most common reason for revision of LAGB in this series. We postulate that SPD is caused by excessive pressure in the proximal gastric pouch. This may be generated either by eating too quickly or too large a volume or excessive tightening of the band. The radial forces in the pouch may ultimately cause pressure on the phrenoesophageal ligament and a secondary hiatal hernia.

Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial.

CONTEXT: Observational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes. OBJECTIVE: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: Conventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric banding with conventional diabetes care. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: actr.org Identifier: ACTRN012605000159651.

Substantial intentional weight loss and mortality in the severely obese.

OBJECTIVE: To compare all-cause mortality in a surgical weight loss cohort with a similarly aged, obese population-based cohort. SUMMARY BACKGROUND DATA: Significant weight loss following bariatric surgery improves the comorbidities associated with obesity. Improved survival as a result of surgical weight loss has yet to be clearly demonstrated using clinical data. METHODS: The surgical weight loss cohort was a series of consecutive patients treated with a laparoscopic adjustable gastric band in Melbourne between June 1994 and April 2005. The Melbourne Collaborative Cohort Study (MCCS) provided a community control cohort, recruited between 1992 and 1994 and followed to June 2005 to determine vital status. Height and weight were recorded at baseline in both studies. Subjects between 37 and 70 years and with a body mass index (BMI) of > or =35 were included. Vital status was determined by follow-up and searching of death registries. Survival time was compared using Kaplan-Meier estimates, and hazard of death was determined using Cox regression, adjusting for sex, age at baseline, and BMI at baseline. RESULTS: Of 966 weight loss patients (mean age 47 years, mean BMI 45 kg/m), the median follow-up time was 4 years. Mean weight loss after 2 years was 22.8% +/- 9% (58% of excess weight). The MCCS cohort included 2119 severely obese members (mean age, 55 years; mean BMI, 38 kg/m; median follow-up time, 12 years). There were 4 deaths in the weight loss cohort and 225 deaths in the MCCS cohort. Weight loss patients had 72% lower hazard of death than the community control cohort (hazard ratio, 0.28; 95% confidence interval, 0.10-0.85). CONCLUSIONS: Substantial surgical weight loss in a morbidly obese population was associated with a significant survival advantage.

Daytime sleepiness in the obese: not as simple as obstructive sleep apnea.

OBJECTIVE: Excessive daytime sleepiness is a common symptom in obese patients, but what drives this condition is unclear. The objective was to look for clinical, anthropometric, biochemical, and polysomnographic predictors of excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS) in obese patients. RESEARCH METHODS AND PROCEDURES: The ESS questionnaire was completed by 1,055 consecutive patients presenting for obesity surgery. Those at high risk for obstructive sleep apnea (n = 331) had diagnostic overnight polysomnography preoperatively. All patients had preoperative clinical, hematologic, and biochemical measurements and completed multiple questionnaires. RESULTS: There was no significant relationship between ESS score and any measure of diagnostic polysomnography factors, including total apnea hypopnea index. Subtle increases in ESS scores were reported in men, older patients, and those with type 2 diabetes. However, general demographic, anthropometric, and biochemical measures of the metabolic syndrome explained only 3% of ESS score variance, and inflammatory markers of C-reactive protein and total white cell count were not predictive. Poor Short Form-36 energy scores (b = -0.18, p < 0.001) and high Beck Depression Inventory scores were predictive of higher ESS scores (b = 0.15, p < 0.001) and, along with increasing age and male gender, explained 10% of variance. Symptoms related to disturbed nocturnal sleep explained 30% of variance. CONCLUSION: In severely obese subjects, increased daytime sleepiness does not seem to be driven by obstructive sleep apnea, the degree of obesity, or anthropometric, metabolic, or inflammatory markers of the metabolic syndrome. It is, however, associated with poor energy, symptoms of depression, and symptoms of nocturnal sleep disturbance.

Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial.

BACKGROUND: 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. OBJECTIVE: To ascertain whether surgical therapy for obesity achieves better weight loss, health, and quality of life than nonsurgical therapy. DESIGN: Randomized, controlled trial. SETTING: University departments of medicine and surgery and an affiliated private hospital. PATIENTS: 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). MEASUREMENTS: Outcome measures were weight change, presence of the metabolic syndrome, and change in quality of life at 2 years. RESULTS: 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). LIMITATIONS: The study included mildly and moderately obese participants, was not powered for comparison of adverse events, and examined outcomes only for 24 months. CONCLUSIONS: 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.

A prospective randomized trial of placement of the laparoscopic adjustable gastric band: comparison of the perigastric and pars flaccida pathways.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is a safe and effective method for the treatment of obesity. The most common problem after LAGB has been the occurrence of prolapse (slippage) of the stomach through the band. It has been proposed that the pars flaccida (PF) pathway (dissection from the base of the right crus, along the left crus to the angle of His) is less likely to be associated with prolapse than the traditional perigastric (PG) pathway (dissection between the lesser curvature of stomach and lesser omentum, across the apex of the lesser sac, to the angle of His). We have tested this hypothesis using a randomized controlled trial format. METHODS: We have performed a randomized controlled trial to compare the outcomes after LAGB using PF and PG pathways. 202 patients (mean age 40 years, mean weight 123 kg, mean BMI 45) were randomly allocated to the PF or PG pathway and followed for 2 years. RESULTS: At 24 months, there have been 16 revisional procedures for prolapse, 4 in the PF group (all anterior prolapse) and 15 in the PG group (12 posterior and 3 anterior). This difference is significant (P<0.001). The mean % excess weight lost was 53% for the PF group and 46% for the PG group. There was equally significant improvements in the metabolic syndrome in both groups (59% preoperatively and 19% at 2 years). All 8 paired domain scores of the SF-36 measures of quality of life were improved significantly in both group (P<0.001). CONCLUSIONS: The PF pathway is as effective as the PG pathway in generating substantial weight loss, improved health and improved quality of life and is significantly less likely to be associated with prolapse (slippage). It is recommended as the primary dissection pathway.

Sustained weight loss in obese subjects has benefits that are independent of attained weight.

OBJECTIVE: To explore the hypothesis that sustained weight loss in severely obese patients may have benefits that are independent of their attained BMI. RESEARCH METHODS AND PROCEDURES: We conducted a comparison of two weight-stable groups with BMI in the 30 to 35 kg/m(2) range. Subjects (n = 79) were selected obese patients 3 years after laparoscopic adjustable gastric band surgery, and controls (n = 79) were obese patients seeking weight loss therapy. Subjects were selected in a de-identified manner from our database to best match the control group. A range of clinical, biochemical, and questionnaire measures were obtained to assess obesity-related health status RESULTS: Subjects maintained a mean weight loss of 32.8 +/- 18 kg after surgery. The weight loss subjects had significantly lower fasting plasma glucose, insulin, and triglyceride concentrations, along with higher high-density lipoprotein-cholesterol levels and better indirect measures of insulin sensitivity when compared with controls (p < 0.05 for all). In addition, aminotransferase levels, neutrophil counts, and globulin levels were also significantly lower in weight loss subjects. All differences in laboratory variables remained significant after controlling for BMI. The subjects also reported better health-related quality of life, fewer symptoms of depression, and greater satisfaction with their appearance than controls. DISCUSSION: These findings suggest that the post-weight loss state conveys benefits that are greater than predicted by the attained BMI. These findings may have important implications regarding the expectations of weight loss therapy, and mechanisms for this effect should be carefully sought.