Effects Of Adjustable Gastric Banding Research Articles

Effect of adjustable gastric banding on quality of life and weight loss in the Helping Evaluate Reduction in Obesity (HERO) registry study: 2 year analysis

Objective:This report from the Helping Evaluate Reduction in Obesity (HERO) Study investigated weight loss, health-related quality of life (HRQOL), and factors predictive of HRQOL improvement during a 2 year period following Lap-Band AP implantation (post-LBAP).Research design and methods:This prospective, observational study included patients with 1 and 2 year follow-up data post-LBAP (N = 585). Changes in body mass index (BMI), percentage of weight loss (%WL), excess weight loss (%EWL) and HRQOL (Impact of Weight on Quality of Life [IWQOL]–Lite measure), and differences between <30% EWL and ≥30% EWL subgroups were assessed at 1 and 2 years post-LBAP. Multiple linear regression examined association of %EWL groups with IWQOL-Lite scores controlling for age, gender, region (US vs outside US), household income, employment status, and comorbidities.Results:Most patients were female (80.2%) and from the US (64.8%); overall mean (SD) age was 43.6 (11.28) years and 65.8% of patients had ≥30% EWL at year 2. At 2 years post-LBAP, mean %EWL was 43.5%; %EWL was 12.4% in the <30% EWL group and 59.6% in ≥30% EWL group (P ≤ 0.0001). Changes in IWQOL total and subscores were significantly greater in ≥30% EWL versus <30% EWL patients (all P < 0.0005) at years 1 and 2; Self-Esteem and Physical subscores had the largest changes. Multiple regression analysis showed that patients with ≥30% EWL had clinically meaningful improvements in HRQOL compared with patients having <30% EWL (P ≤ 0.001). Similarly, US patients and females had a clinically significant change in IWQOL score versus their counterparts (P ≤ 0.001). Conversely, income, comorbidities and employment status were not significant predictors of change in IWQOL scores at year 2.Conclusions:These results support and extend findings regarding the effectiveness of LBAP for weight loss and illustrate the importance of ≥30% EWL as a significant factor in predicting clinically significant improvement in HRQOL 1 and 2 years post-LBAP.Clinical trial registration:NCT00953173.

PWE-159 The role of an internal pilot rct to inform the design and conduct of a main trial: by-band to by-band-sleeve

Introduction Background The NIHR By-Band Study aims to compare the effectiveness of adjustable gastric band (AGB) and Roux-en-Y gastric bypass (RYGB) for severe and complex obesity. By-Band had an internal pilot phase to establish trial recruitment and to review whether expansion into a three group trial including sleeve gastrectomy was appropriate. This paper describes how the By-Band internal pilot informed successful adaptation to By-Band-Sleeve. Methods The internal pilot phase started in two centres in November 2012. After 24.4 centre months of recruitment, data on the pre-agreed decision criteria were reported to the trial funder to inform progression to the main trial. Criteria focused on rates of referrals for surgery, trial eligibility, recruitment and cross over. Evidence from reported and open RCTs including sleeve gastrectomy (SG) was scrutinised and data on SG practice summarised. Results In two centres 333 patients were screened, 231 (69%) found eligible and 80 consented to randomisation (35%). Cross over rates were 3.5% with similar numbers crossing over from AGB to RYGB and vice versa. The updated Cochrane review of bariatric surgery identified 22 trials of AGB, RYBG or SG. All trials were at a moderate or unclear risk of bias and external validity poor. There was only one trial comparing SG with AGB. Current open trials were also at risk of bias. UK practice showed that whilst AGB was decreasing in incidence in the public sector it remained the commonest procedure undertaken in the reported private cases. An adapted three-group study was successfully proposed to the NIHR and a contract variation agreed in January 2015 to increase the sample size to 1341 to allow comparisons of all three procedures. Conclusion The study has now recruited 176 patients and is expanding into 7 more centres (total 12). By-Band-Sleeve will be therefore provide high quality evidence to examine which operation is most effective and cost effective for the treatment of severe and complex obesity. Disclosure of interest None Declared.

Effect of adjustable gastric banding on changes in gastroesophageal reflux disease (GERD) and quality of life

Objective:Bariatric surgery is an effective treatment for the reduction of weight in obese patients (BMI ≥ 40 kg/m2 or 30 kg/m2 with ≥1 comorbidities), who are refractory to behavioral and medical therapies. This study examined the effect of the adjustable gastric band (AGB) system on changes in gastroesophageal reflux disease (GERD) and patient-reported outcomes, including measures of quality of life.Methods:Two-year interim analysis of patients (N = 171) in the 5 year, prospective APEX study who reported GERD prior to the AGB procedure. An unrecorded number of hiatal hernia repairs were conducted during the APEX study.Results:At baseline, 171 of 395 patients (43%) reported GERD requiring daily medical therapy. After 2 years, 122 patients had sufficient data to assess outcome (71%). Complete resolution of GERD was reported in 98 patients (80%), improvement in 13 (11%), no change in 9 (7%), and worsening in 2 (2%). Overall, 91% of GERD patients experienced resolution and/or improvement of GERD. Baseline BMI was not significantly different among the GERD response categories (resolved, improved, and stable/worse), p = 0.4581. Mean ΔBMI and percentage excess weight loss (%EWL) were: −8.8 kg/m2/−0.9%, −11.4 kg/m2/−53.9%, −6.4 kg/m2/−36.1%, and −7.1 kg/m2/−31.2%, respectively. There were no significant differences in reductions in BMI or %EWL between responder groups (resolved versus stable/worse ΔBMI p = 0.1031, %EWL p = 0.0667 OR resolved/improved versus stable/worse ΔBMI p = 0.0918, %EWL p = 0.0552). After 2 years, resolution or improvement occurred in pre-existing comorbidities: type 2 diabetes (96%), hypertension (91%), hyperlipidemia (77%), obstructive sleep apnea (86%), osteoarthritis (93%), and depression (75%). Patient satisfaction with AGB was assessed as: very satisfied/satisfied (87%), very satisfied (50%), dissatisfied (5.0%). Quality of life measured by the Obesity and Weight-Loss Quality of Life Instrument (GERD patients) significantly improved from baseline.Conclusion:Obese patients with GERD had meaningful improvement in patient-reported outcomes with the AGB system. In addition, other obesity-related comorbidities and measures of quality of life improved.

Long-term results of adjustable gastric banding in a cohort of 186 super-obese patients with a BMI ≥ 50 kg/m2

There are conflicting results concerning the bariatric effectiveness of adjustable gastric banding in super-obese patients with a Body Mass Index (BMI) more or equal to 50 kg/m(2). A cohort of 186 patients with a BMI greater or equal to 50 kg/m(2) who underwent adjustable gastric banding (AGB) at the Bichat-Claude-Bernard University Hospital (Paris, France) were prospectively entered into a database. The following data were recorded: BMI, percentage of BMI loss, percentage of excess weight lost (%EWL), complications, and surgical re-interventions. Loss of greater than 50% of excess weight was considered a success (primary endpoint). A %EWL of less than 25% after one year, or the removal of the gastric band was considered a failure. Thirty-five men (18.8%) and 151 women (81.2%), with a mean age of 38.9 years (range: 16-65) underwent AGB between September 1995 and December 2007. The mean BMI was 55.06 kg/m(2) (range: 50-74.4). Mean follow-up was 112.5 months with a minimum of 28 months and a maximum of 172 months. The follow-up rate was maintained at 89% at ten years. The technique of AGB was by "peri-gastric dissection" in the first 115 patients (61.82%) and by "pars flaccida dissection" in 71 patients (38.17%). The gastric band was removed in 87 of 186 patients (46.8%); band ablation was due to a complication of the gastric band in 62 of these cases (33.3%), to failure of weight loss in 23 cases (12.4%), and to patient request in two cases (1%). The major complications requiring re-operation were: chronic dilatation of the proximal gastric pouch (27 patients - 14.5%), acute dilatation (21 patients - 11.3%), intragastric migration of the prosthesis (six patients - 3.2%), reflux esophagitis (six patients - 3.2%), infection of the gastric band (one patient - 0.5%), and Barrett's esophagus (one patient - 0.5%). No statistically significant difference was found between the two operative techniques with regard to the possibility of preserving the gastric band for ten years. For patients who underwent band removal, no further follow-up analysis of patient data after band ablation was performed. The results were best at two years after AGB with a median BMI of 42.72 kg/m(2), a band removal rate of 8.6% (16 of 186 patients), and a failure rate of 16.4% (28 of 170 patients) of those patients who still had their band in place. However, at 10 years, the picture was completely reversed with a band removal rate of 52.2% (47 of 90 patients), a failure rate of 22% (seven of 33 patients) of those who still had their band in place, and a median BMI of 43.43 kg/m(2). Laparoscopic gastroplasty using the adjustable gastric band appeared to be a promising intervention for super-obese patients when the results at two years were analyzed - fairly simple to perform, with perioperative morbidity and mortality near zero. However, these results do not persist in the long-term for super-obese patients. At ten years, only 11% of patients (nine of 80) have successful bariatric results (%EWL>50%) and we were forced to remove the gastric band in 52.2% of patients (47 of 90) because of complications, regardless of the initial operative technique used. Given these results, AGB gastroplasty is not a recommended method for super-obese patients and we believe that a BMI greater or equal to 50 kg/m(2) is a contra-indication for this procedure.

Mechanisms underlying the effectiveness of adjustable gastric banding

Mechanisms underlying the effectiveness of adjustable gastric banding

P-90 Effect of adjustable gastric banding on obesity and weight-loss quality of life (OWLQOL): 2-year interim results of the APEX study

Laparoscopic Adjustable Gastric Banding has been established as a safe and effective treatment to reduce weight in severely obese patients (>40 kg/m2 or >35 kg/ m2 with > one co-morbidity). The aim of this report is to summarize the 2-year prospective outcomes based on the Obesity and Weight-Loss Quality of Life (OWLQOL) instrument after surgical placement of the LAP-BAND AP® device.

The effectiveness of adjustable gastric banding: a retrospective 6-year U.S. follow-up study

This study aimed to assess the efficacy of laparoscopic adjustable gastric banding (LAGB) during a 6-year follow-up period. A retrospective database analysis of patients who underwent LAGB at New York University Medical Center between 1 January 2000 and 29 February 2008 was conducted. Patients were included for the efficacy analysis if they were 18 years old or older at the surgery date and had one or more visits with a recorded weight after surgery. Efficacy was assessed using percentage of excess weight loss (%EWL) at 1-year intervals after surgery. Missing weight values were interpolated using a cubic spline function. Linear regression models were used to assess the characteristics that affected the last available %EWL. All patients had implantation of the LAP-BAND system. The inclusion criteria for the efficacy analysis were met by 2,909 patients. The majority of the patients were white (83.3%) and female (68.4%). The mean patient age was 44.6 years, and the mean baseline body mass index (BMI) was 45.3 kg/m2. The %EWL 3 years after surgery was 52.9%, which was sustained thereafter. In multivariate models, increased number of office visits, younger age, female gender, and Caucasian race were significantly associated with a higher maximum %EWL. The LAP-BAND patients achieved a substantial and sustainable weight loss of approximately 50% at 6 years after surgery.

Effects of adjustable gastric banding on gastroesophageal reflux and esophageal motility: a systematic review

Controversial opinions exist concerning the effect of laparoscopic adjustable gastric banding on gastroesophageal reflux. MEDLINE and EMBASE databases were searched for relevant studies on patients undergoing adjustable gastric banding. Data are expressed in mean (range). Twenty studies were identified with a total of 3307 patients. The prevalence of reflux symptoms decreased postoperatively from 32.9% (16-57) to 7.7% (0-26.9) and medication use from 27.5% (16-38.5) to 9.5% (3.1-19.2). Newly developed reflux symptoms were found in 15% (6.1-20) of the patients. The percentage of esophagitis decreased postoperatively from 33.3% (19.4-61.6) to 27% (2.3-60.8). Newly developed esophagitis was observed in 22.9% (0-38.4). Pathological reflux was found in 55.8% (34.9-77.4) preoperatively and postoperatively in 29.4% (0-41.7) of the patients. Lower esophageal sphincter pressures increased from 12.9 to 16.9 mmHg (11.3-21.4). Lower esophageal sphincter relaxation decreased from 100% to 79.7% (58-86). The percentage of dysmotility increased from 3.5% (0-10) to 12.6% (0-25). Adjustable gastric banding has anti-reflux properties resulting in resolution or improvement of reflux symptoms, normalized pH monitoring results and a decrease of esophagitis on short term. However, worsening or newly developed reflux symptoms and esophagitis are found in a subset of patients during longer follow-up.

Quality of life after gastric banding in morbidly obese Dutch patients: Long-term follow-up

Long-term effects of adjustable gastric banding (AGB) on quality of life (QoL) in a morbidly obese population were investigated in a cross-sectional study. Additionally, determinants of QoL after AGB were assessed. All patients treated by AGB for morbid obesity in a Dutch hospital were invited to complete the RAND 36-Item Health Survey. Of 121 participating patients 59 met the criteria for long-term follow-up (>5 years): 4 male and 55 female, mean age 42.4 ± 9.7 years, mean body mass index (BMI) before surgery 44.9 ± 5.9 kg/m(2). Time since surgery was 74.7 months (range 60-107.6). The control group consisted of 28 presurgical patients. General and obesity-related parameters were assessed for correlation with QoL. Significant differences between the preoperative group and Dutch community norm (CN) values were found on five out of eight QoL subscales, in favor of CN. AGB induced significant weight loss in the postoperative group: 56.1% excess weight loss (%EWL). This group scored significantly better than the preoperative group on one out of eight subscales: physical functioning (P = 0.019). Additionally, scores on four out of eight subscales were still significantly impaired compared to CN. Postoperative BMI and %EWL influenced QoL after long-term follow-up, whereas weight regain had no negative impact. This study shows that after long-term follow-up subjects treated by gastric banding to induce weight loss have a slightly better QoL than those who did not undergo surgery yet. QoL remains impaired in comparison to the general population. After long-term follow-up BMI and weight loss do influence QoL whereas weight regain does not have any negative impact.

Effects of adjustable gastric banding on altered gut neuropeptide levels in morbidly obese patients.

Patients with gastroesophageal reflux disease (GERD) have alterations of gut neuropeptides, such as neurotensin (N) and motilin (M), which are resolved following antireflux surgery. Obesity is associated with GERD. Since the adjustable gastric band prevents gastroesophageal reflux in morbidly obese patients, this study was performed to investigate plasma levels of N and M before and after adjustable gastric banding (AGB). 47 morbidly obese patients were operated laparoscopically using the Swedish AGB. Pre- and postoperatively basal plasma levels of N and M were investigated. Symptoms such as heartburn, regurgitation and dysphagia were documented, and esophageal manometry as well as 24-hour pH-monitoring were performed pre- and postoperatively. 11 non-obese, asymptomatic, age-matched volunteers served as controls. After a median postoperative follow-up period of 268 days, a significant weight reduction was observed. Preoperatively, 14 patients suffered from reflux symptoms. An insufficient lower esophageal sphincter (LES) was found in 8 patients, and 2 patients had impaired esophageal body motility. Pathologic pH-testing was found in 6 patients. Postoperatively, reflux symptoms were present in 4 patients; LES findings and pH-testing were normalized in all patients. However, there was significant impairment of esophageal peristalsis. Preoperatively, levels of N were significantly decreased and levels of M increased compared with control subjects. Postoperatively, there was a significant increase of N and levels of M were normalized. Alterations in gut neuropeptides did not correlate with reflux symptoms, impaired gastroesophageal motility, age, gender or BMI. Morbid obesity alters gut neuropeptides, which are resolved by AGB. This may be caused by reduction of hypercaloric nutrition postoperatively rather than by improvement of gastroesophageal reflux.