Five Percent Weight Lost in the First Month of Intragastric Balloon Treatment May Be a Predictor for Long-Term Weight Maintenance

Background

Most of the weight loss with the BioEnterics intragastric balloon (BIB) has occurred during the first 3–4 months. This study aimed to evaluate the effect of initial weight loss on long-term weight maintenance.

Methods

From 2008 to 2011, 50 patients who had mean body mass index (BMI) of 44.7?±?12.4 kg/m² underwent BIB therapy for 6 months. All patients were given a diet of 1,100 kcal/day. Weight loss parameters [absolute weight loss, BMI loss, percentage of body weight loss (BWL%), and percentage of excess BMI loss] were recorded at the baseline, 1 month, 6 months (time of BIB removal), 12 months, and 18 months from the baseline. Successful weight loss was defined as ≥10 % weight loss after 6, 12, and 18 months.

Results

Twenty-seven patients (54 %) achieved a percentage of BWL?≥?10 at the time of removal. Eighteen (36 %) and 12 (24 %) patients were able to maintain weight loss of 10 % at 12 and 18 months. Percentage of BWL after 1 month was positively correlated with BWL% after 6, 12, and 18 months (r?=?0.77, 0.65, and 0.62, p?<?0.001, respectively). Twenty-four patients who lost 5 % of the BWL after 1 month of treatment succeeded in maintaining a lasting percentage of BWL ≥10 after the BIB removal: more precisely, this cutoff point was achieved in 96 % at the time of removal and in 71 %, 50 % at 12 months, and 18 months of follow-up.

Conclusions

Five percent BWL after 1 month of treatment may be a predictor for long-term weight maintenance.     

Adjustable Intragastric Balloon vs Non-Adjustable Intragastric Balloon: Case–Control Study on Complications, Tolerance, and Efficacy

Background

The objective of this study is the comparison of a new intragastric balloon recently introduced, the Adjustable Balloon System (ABS), with the BioEnterics intragastric balloon (BIB) in terms of tolerance, safety, and weight loss parameters.

Methods

A case–control study was done: 40 patients were matched with 80 controls. To achieve the same duration therapy (12 months), a single ABS positioning was compared with a BIB followed by another BIB (6?+?6 months). Length of procedure, hospital stay, complications, and weight loss parameters after 6 months (time of first BIB removal) and after 12 months from baseline (time of Spatz and second BIB removal) were considered. Statistical analysis was done by means of Student’s t test, χ2 test, or Fisher’s test. P?<?0.05 was considered significant.

Results

Mortality, positioning, and extraction complications were absent. Both the devices were well tolerated with slight duration of post placement symptoms. During this study, the Spatz balloon was adjusted with inflation of 200 cm³ of saline (total, 800 cm³) in 9/40 (22.5 %) patients, for poor weight loss after first 6-months treatment. In the Spatz group, there occurred 7/40 complications linked to the device and in 6/7 patients the balloon was removed. At the end of the study, the weight loss parameters were similar between groups: BMI 31.0?±?11.8 (Spatz group) vs 31.3?±?12.3 (BIB group) (p?=?Ns).

Conclusions

The idea of dynamic balloon therapy needs to be confirmed with wider series. The rate of complication reported is very high, and several studies regarding safety and efficacy are needed.     

Intragastric Balloon Followed by Diet vs Intragastric Balloon Followed by Another Balloon: A Prospective Study on 100 Patients

Aim of this study is to compare the efficacy of BioEnterics Intragastric Balloon (BIB®) followed by diet with BIB followed by another BIB. A prospective study was designed: a homogeneous group of 100 obese patients (age range 25–35, BMI range 40.0–44.9, M/F ratio 1/4) was allocated into two groups according to procedure: BIB (6 months) followed by diet therapy (7 months; group A?=?50 pts), BIB positioning followed by another BIB after 1 month (group B?=?50 pts). Baseline demographics were similar in both groups (Group A 10M/40F; mean age 31.4?±?2.6; range 25–35; mean weight 106.3?±?12.5 Kg; range 88–150; mean BMI 42.6±2.7 Kg/m²; range 40.2–43.8; Group B 10M/40F; mean age 32.1?±?2.1; range 25–35; mean weight 107.1?±?11.9 Kg; range 90–150; mean BMI 42.9?±?2.3; range 40.2–43.9). In both groups, weight loss parameters (Kg, BMI, and % EBL) were considered. Statistics were by Fisher’s exact test (p?p?2 (range 24–40), and 35.9?±?9.7 Kg/m² (range 34–42); mean % EBL was 51.9?±?24.6% (range 0–100) and 25.1?±?26.2% (range 0–100) in group B and A, respectively. As compared with diet, a second intragastric balloon can be positioned without difficulties, achieving good results with continuous weight loss.     

Intragastric Balloon in Association with Lifestyle and/or Pharmacotherapy in the Long-Term Management of Obesity

Background

Intragastric balloon (BioEnterics Intragastric Balloon, BIB®) or pharmacotherapy are possible options for the treatment of obese patients when traditional approaches have failed. The aim of our study was to compare in obese patients the effect on weight loss and metabolic changes of lifestyle modifications associated with either BIB or pharmacotherapy or the two treatments in sequence as a maintenance strategy for weight loss.

Methods

Fifty obese patients were recruited and randomly assigned to lifestyle modifications combined with either BIB for 6 months (n?=?30) or sibutramine (pharmacotherapy group) for 1 year (n?=?20). After BIB removal, patients were randomly assigned to either correct lifestyle (BIB/lifestyle) or lifestyle plus pharmacotherapy (BIB/pharmacotherapy).

Results

At 6 months, patients treated with BIB lost significantly (P?P?P?

Conclusions

BIB represents an efficacious long-term obesity treatment when supplemental strategies, as lifestyle modifications or pharmacotherapy, are established for weight maintenance after its removal.

     

Multi-Centre European Experience with Intragastric Balloon in Overweight Populations: 13 Years of Experience

Background

The request to lose weight is expanding not only in obese and morbidly obese patients but also in overweight patients affected by co-morbidities as diabetes and hypertension and who do not tolerate diet regimen or lifestyle changes. The aim of this study is a multicenter evaluation of outcomes of intragastric balloon in overweight patients.

Methods

Patients (BMI 27–30 kg/m²) treated with a BioEnterics Intragastric Balloon (BIB) between 1996 and 2010 were extracted from the database of the participating centres in Rome (Italy), Liège (Belgium) and Madrid (Spain). Primary endpoints were the efficacy and safety at 6 and 42 months from balloon positioning. Secondary endpoints included resolution of co-morbidities.

Results

A total of 261 patients were included in this study. The most common indication for balloon placement was a psychological disorder (54 %). Mean body mass index (BMI) fell from 28.6?±?0.4 at baseline to 25.4?±?2.6 kg/m² at 6 months and to 27.0?±?3.1 kg/m² at 3 years from BIB removal. The mean %EWL was 55.6 % at 6 months and 29.1 % at 3 years. Forty-seven patients (18 %) had complications associated with placement of the intragastric balloon (leak?=?28, intolerance?=?14, duodenal ulcer?=?2, gastritis?=?1, oesophagitis?=?1, duodenal polyps?=?1). The rate of patients with hypertension decreased from 29 % at baseline to 16 % at 3 years. Diabetes decreased from 15 to 10 %, dyslipidaemia decreased from 20 to 18 %, hypercholesterolaemia decreased from 32 to 21 % and osteoarthropathy decreased from 25 to 13 %.

Conclusions

The intragastric balloon is safe and effective in overweight patients, helping to reduce progression to obesity and decreasing the prevalence of a number of important co-morbidities.     

Impact of Obesity on Perioperative Outcomes and Survival Following Pancreaticoduodenectomy for Pancreatic Cancer: A Large Single-Institution Study

Background

To examine the effect of body mass index (BMI) on clinicopathologic factors and long-term survival in patients undergoing pancreaticoduodenectomy for pancreatic adenocarcinoma.

Methods

Data on BMI, weight loss, operative details, surgical pathology, and long-term survival were collected on 795 patients who underwent pancreaticoduodenectomy. Patients were categorized as obese (BMI?>?30 kg/m²), overweight (BMI 25 to <30 kg/m²), or normal weight (BMI?<?25 kg/m²) and compared using univariate and multivariate analyses.

Results

At the time of surgery, 14% of patients were obese, 33% overweight, and 53% normal weight. Overall, 32% of patients had preoperative weight loss of >10%. There were no differences in operative times among the groups; however, higher BMI was associated with increased risk of blood loss (P?<?0.001) and pancreatic fistula (P?=?0.01). On pathologic analysis, BMI was not associated with tumor stage or number of lymph nodes harvested (both P?>?0.05). Higher BMI patients had a lower incidence of a positive retroperitoneal/uncinate margin versus normal weight patients (P?=?0.03). Perioperative morbidity and mortality were similar among the groups. Obese and overweight patients had better 5-year survival (22% and 22%, respectively) versus normal weight patients (15%; P?=?0.02). After adjusting for other prognostic factors, as well as preoperative weight loss, higher BMI remained independently associated with improved cancer-specific survival (overweight: hazard ratio, 0.68; obese: hazard ratio, 0.72; both P?<?0.05).

Conclusion

Obese patients had similar tumor-specific characteristics, as well as perioperative outcomes, compared with normal weight patients. However, obese patients undergoing pancreaticoduodenectomy for pancreatic cancer had an improved long-term survival independent of known clinicopathologic factors.     

Laparoscopic sleeve gastrectomy versus intragastric balloon: a case-control study

Aim

To compare the efficacy of laparoscopic sleeve gastrectomy (LSG) and BioEnterics intragastric balloon (BIB^®) to lose weight and comorbidities after 12 months of follow-up before a more invasive bariatric procedure.

Methods

From January 2004 to December 2006, 40 patients underwent laparoscopic sleeve gastrectomy (LSG) as a first step in biliopancreatic diversion with duodenal switch. Controls (n = 80) were selected based on charts of patients who, during the same period, underwent BioEnterics intragastric balloon therapy. In both groups we considered: length of procedure, hospital stay, intraoperative or endoscopic complications, postoperative or postendoscopic complications, comorbidities at baseline, after 6 months (time of BIB removal), and after 12 months from baseline, and weight loss parameters [weight in kg, percentage excess weight less (%EWL), body mass index (BMI), and percentage excess BMI loss (%EBL)]. Results are expressed as mean ± standard deviation.

Results

Mortality, intra- and postoperative complications (in LSG group), and intra- and postendoscopic complications (in BIB group) were absent. Mean operative time in the LSG group was 120 ± 40 (range 60–200) min. Mean positioning time for BIB was 15 ± 5 (range 10–25) min. BMI at baseline was 54.1 ± 2.9 (range 45.1–55.9) kg/m² and 54.8 ± 2.5 (range 45.1–56.2) kg/m² in BIB and LSG groups, respectively. At 6-month follow-up, mean BMI was 46.2 ± 3.5 and 45.3 ± 5.5 kg/m² in the BIB and LSG patients, respectively [p = not significant (ns)]. After 12 months BIB patients regained BMI, even if strictly followed with a diet regimen, while LSG patients continued to lose weight. Significant differences between groups were absent for the comorbidities considered.

Conclusions

Laparoscopic sleeve gastrectomy and BioEnterics intragastric balloon are two valid options for producing weight loss as a first-step procedure. LSG has all the related risks of general anesthesia, laparoscopic surgery, and digestive anastomosis, whereas BIB presents a very low rate of minor complications, such as psychological intolerance. For all these reasons, at this time, BIB is considered a better option than LSG as a first-step procedure in the short term (12 months).     

Air-Filled vs Water-Filled Intragastric Balloon: a Prospective Randomized Study

Background

The positioning of an intragastric saline-filled balloon has been developed as temporary and reversible therapeutic option for treatment of morbid obesity. Recently, an air-filled balloon was also developed. The aim of this study is to prospectively compare these two devices in terms of weight loss parameters, safety, and tolerance.

Methods

Sixty patients were randomized into two groups: group A (Bioenterics Intragastric Balloon?CBIB; n?=?30; 20?F/10?M, mean age 36.7?±?10.9; mean BMI 46.5?±?5.9) and group B (Endobag-Heliosphere; n?=?30; 20?F/10?M, mean age 37.8?±?10.6; mean BMI 46.1?±?5.6). All patients of both groups were sedated with midazolam (5?mg)?+?Propofol (2?mg/kg i.v.). The Heliosphere Bag was air-filled with 950?ml while BIB? was inflated with 500?ml of saline and 10?ml of methylene blue. Percentage of excess weight loss (%EWL) and body mass index (BMI) were evaluated. Student t test, Fisher exact test, and ?? ² test were used for statistical analysis.

Results

Similar weight loss parameters were observed in patients treated with liquid or air-filled balloon at time of removal: mean BMI was 40.8?±?6.2 and 41.9?±?6.5(p?=?ns), and mean %EWL was 20?±?12 and 18?±?14 (p?=?ns) in groups A and B, respectively. Significant longer extraction time, with high patient discomfort, was observed in group B due to difficult passage through the cardia and the lower pharynx.

Conclusions

Air-filled balloon can be another valid therapeutic option in the temporary treatment of obesity, but at this time, the quality of the device must be improved to ameliorate the patient compliance at removal and avoid the spontaneous deflations.     

Effects of Laparoscopic Adjustable Gastric Banding on Weight Loss,Metabolism, and Obesity-Related Comorbidities: 5-year Results in China

Background

Despite some reports about the long-term metabolic outcomes after laparoscopic adjustable gastric banding (LAGB) in the Western populations, there are few reports on the Asian population whose body size and fat distribution are different. Therefore, this study was conducted to evaluate the medium-term effects of LAGB on weight loss and metabolic outcomes of obese patients with different body mass index (BMI) in China.

Methods

A retrospective study was performed to review the 5-year follow-up data of 56 patients (18 males, 38 females) who received LAGB from November 2003 to May 2013 at the Shanghai Changhai Hospital. The patients were evaluated at years 1, 3, and 5 after operation in the outpatient clinic, and the weight loss, metabolic parameters, and remission of comorbidities were measured.

Results

The 56 patients preoperatively had BMI of 37.4?±?6.0 kg/m², with BMI?<?35 kg/m² in 19 patients (BMI <35 kg/m² group), and BMI?≥?35 kg/m² in 37 patients (BMI?≥?35 kg/m² group). The percentages of excess weight loss (%EWL) of the BMI?<?35 kg/m² group at years 1, 3, and 5 were 65.2, 65.6, and 65.7 %, respectively, indicating the majority of metabolic parameters were significantly improved (P?<?0.05). However, in the BMI?≥?35 kg/m² group, the %EWL were 37.9, 34.8, and 26.5 %, respectively, except at year 1 when the metabolic parameters improved significantly (P?<?0.05), those at year 3 and year 5 did not significantly improve compared with the preoperative levels. Similar results were observed in the improvement of comorbidities.

Conclusions

Relatively low medium-term weight loss, metabolic improvement, and resolution or remission of obesity-related comorbidities and high reoperation rate were observed in our population of patients with BMI?≥?35 kg/m² who underwent LAGB.     

In non-obese patients, duration of action of rocuronium is directly correlated with body mass index

Background

Administration of neuromuscular blocking agents using a dose calculated on actual body weight carries a risk of prolonged duration of action in obese patients whose body mass index (BMI) is > 30 kg·m^?2. In the present study, we hypothesized that there could be a correlation between BMI and the duration of action of rocuronium administered according to actual body weight in non-obese patients, in particular, overweight (BMI 25-30 kg·m^?2) and underweight patients (BMI < 18.5 kg·m^?2).

Methods

Sixteen female patients (BMI 15-30 kg·m^?2, aged 45-60 yr) scheduled for elective surgery under total intravenous anesthesia were included in this study. Rocuronium 0.9 mg·kg^?1 was administered, and adductor pollicis train-of-four responses following ulnar nerve stimulation were monitored every minute with acceleromyography. The times from the injection of rocuronium until spontaneous recovery of first twitch to 5% (5% Duration) and 25% (25% Duration) of baseline were measured, and the correlation with BMI was analyzed.

Results

A significant correlation between 5% Duration and BMI (r² = 0.56; P < 0.001) was found by linear regression analysis. A significant correlation was also found between 25% Duration and BMI (r² = 0.49; P = 0.003).

Conclusion

In adult female patients with a BMI in the range of 15-30 kg·m^?2, the duration of action of rocuronium increases with BMI when the drug is administered on the basis of mg per actual kg body weight.     

Bariatric Therapy with Intragastric Balloon Improves Liver Dysfunction and Insulin Resistance in Obese Patients

Background

Obesity is often associated with fatty liver (FL). In most cases, bright liver at ultrasound (US) and increased alanine aminotransferase (ALT) and gamma-glutamyltranspeptidase (GGT) levels are considered the hallmarks of nonalcoholic fatty liver disease (NAFLD). Insulin resistance (IR) is the main link between obesity and NAFLD. The use of the Bioenterics® intragastric balloon (BIB) is a safe procedure either for inducing a sustained weight loss with diet support or for preparing those patients who are candidates for bariatric surgery. The aim of the study was to investigate whether the weight loss induced by intragastric balloon might improve IR and liver enzymes. The presence or absence of FL at US and the influence of a body mass index (BMI) decrease ≥10% after BIB (ΔBMI?≥?10%) were also considered.

Methods

One hundred and three consecutive obese (BMI?>?30 kg/m²) patients (38 males/65 females; mean age 41.3, range 20–63 years) underwent BIB insertion under endoscopic control. The BIB was removed 6 months later. US, clinical, and routine laboratory investigations were performed before and after BIB. IR was calculated by the homeostasis model assessment (HOMA-IR?>?2.5). Exclusion criteria were hepatitis B virus positive, hepatitis C virus positive, alcohol consumption >30 g/day, history of hepato-steatogenic drugs, and type 1 diabetes.

Results

Ninety-three patients were eligible for the study. The BMI significantly decreased in all investigated patients, and it was ≥10% in 59% of the patients. FL was seen at US in 70%, impaired fasting blood glucose was present in 13%, ALT exceeded the normal limit in 30.1%, GGT exceeded the normal limit in 15%, and HOMA-IR was >2.5 in 85%. Median HOMA-IR decreased significantly in FL (4.71 vs 3.10; p?p?p?p?p?p?p?p?

Conclusions

Weight loss induced by intragrastric balloon reduces IR. The ALT and GGT decrease suggests an improvement in hepatic damage. The benefit depends on the decrease of BMI higher than 10%.

     

Long-Term Outcomes of Laparoscopic Adjustable Silicone Gastric Banding (LAGB) in Moderately Obese Patients With and Without Co-morbidities

Background

Overweight and obesity independently increase cardiovascular risk, while even modest weight loss can result in clinically significant improvements in cardiovascular risk and reduce long-term mortality. Lowering the body mass index (BMI) threshold for bariatric surgery to those with moderate obesity might be one way to lower the burden of this disease. The aim of this study was to evaluate the efficacy and safety of laparoscopic adjustable silicone gastric banding (LAGB) in moderately obese subjects with or without obesity-related co-morbidities.

Methods

Thirty-four patients with BMI between 30 and 35 kg/m² (5 males/29 females, mean age 36?±?10 years, mean preoperative weight 87.9?±?7.1 kg, mean BMI 32.6?±?1.6 kg/m² and mean percentage excess weight 48.7 ± 9 %) who underwent LAGB via pars flaccida between June 1, 2002 and August 31, 2010 were included. Good response was defined as BMI <30 kg/m² or percentage estimated weight loss (%EWL) >50. Poor response was defined as BMI >30 kg/m² or %EWL less than 50 after a minimum of 1 year.

Results

Mean weight, BMI and %EWL were recorded at 1, 3, 5 and 7 years and were 77.4?±?7.6, 69.9?±?10.8, 70.9?±?9.3 and 73.3?±?12.0 kg; 28.8?±?2.9, 26.4?±?3.2, 26.5?±?3.4 and 27.4?±?5.0 kg/m²; and 36?±?23, 46.1?±?33.8, 58.6?±?31.5 and 45?±?57, respectively (p?<?0.01). Co-morbidities were diagnosed in 17/34 (50 %) patients at baseline and underwent remission or improvement in all cases after 1 year.

Conclusions

LAGB in a safe and effective procedure in patients with a BMI <35 kg/m².     

Circulating SIRT1 Increases After Intragastric Balloon Fat Loss in Obese Patients

Background

Sirtuins (SIRTs), ubiquitous deacetylases, are main regulators of energy homeostasis and metabolism. SIRT1 has a positive impact on obesity, diabetes mellitus, liver steatosis, and other metabolic disorders. Lean subjects have higher expression of SIRT1 in the adipose tissue compared to obese. However, it is not known whether weight loss associates with changes in blood SIRT1. We evaluated the effect of weight loss on circulating SIRT1, metabolic parameters, and body composition.

Methods

Thirty-two obese subjects were studied before and 6 months after BioEnterics® Intragastric Balloon (BIB®) [22 patients, BMI 41.82?±?6.28 kg/m²] or hypocaloric diet [10 patients, BMI 38.95?±?6.90 kg/m²]. Plasma SIRT1, body composition, measures of metabolic syndrome (waist circumference, fasting plasma glucose, blood pressure, HDL cholesterol, triglycerides), and inflammation markers (ESR, CRP, fibrinogen) were recorded.

Results

SIRT1 levels showed a significant increase, together with a significant reduction of BMI, excess body weight, and total fat mass either after BIB or diet intervention. The percent excess body weight loss was 33.73?±?19.06 and 22.08?±?11.62 % after BIB and diet, respectively, a trend toward a metabolic and inflammatory amelioration was observed with both treatments. Negative correlation between SIRT1 and % fat mass (BIB, ρ?=??0.537, p?=?0.017; diet, ρ?=??0.638, p?=?0.047) was also seen.

Conclusions

The reduction of fat mass associates with increased plasma SIRT1 indicating that, besides tissue levels, circulating SIRT1 is stimulated by a negative caloric balance. The rise of plasma SIRT1 may represent a parameter associating with fat loss rather than weight lowering regardless of the weight reduction system method used.

     

Laparoscopic Greater Curve Plication in Asia: Initial Experience

Background

This study aimed to evaluate the effectiveness and safety of laparoscopic greater curve plication (LGCP) for the treatment of obesity in ethnic Chinese in Hong Kong.

Methods

Twenty-seven consecutive Chinese patients (23 females; mean age 37.6?±?8.9 years) received LGCP for the treatment of obesity from September 2010 to December 2011. Mean baseline body weight (BW) and body mass index (BMI) were 84.6?±?17.5 kg and 31.2?±?4.7 kg/m², respectively.

Results

All procedures were performed laparoscopically with conversion to open surgery in one patient. There was neither mortality nor any postoperative complications. Mean follow-up was 10.6?±?6.5 months. Mean procedure time was 117.9?±?22.3 min and mean hospital stay was 2.6?±?0.7 days. Mean BMI loss was 4.1?±?1.6, 4.8?±?2.0 and 5.2?±?2.5 kg/m² at 3, 6 and 12 months. Mean % EBL was 67.3?±?42.1, 66.4?±?35.9 and 60.2?±?25.5 % at 3, 6 and 12 months. Mean % EBL in BMI >35 group (n?=?7) was 38.2?±?11.1, 43.5?±?14.0 and 50.6?±?21.6 % at 3, 6 and 12 months. Mean % EBL in BMI <35 group (n?=?20) was 76.5?±?44.2, 76.5?±?38.2 and 65.0?±?27.0 % at 3, 6 and 12 months.

Conclusions

LGCP is safe and effective in achieving significant weight loss in obese ethnic Chinese patients. However, weight loss in BMI <35 is more pronounced. It is a very valid alternative to other procedures in Asian population.     

Overweight Patients Achieve Ideal Body Weight Following Curative Gastrectomy Resulting in Better Long-Term Prognosis

Background

The relationship between body mass index (BMI) and long-term outcome in gastric cancer patients following radical gastrectomy continues to be debated. We investigated the association between BMI, clinicopathological features, and prognosis in Chinese gastric carcinoma patients.

Methods

A retrospective consecutive cohort study was performed on 1,296 patients who underwent gastrectomy with curative intent at the Tianjin Cancer Institute Hospital between 1999 and 2004. The clinicopathological characteristics, overall 5-year survival rate (OS), and preoperative and six-month postoperative BMIs of both overweight (BMI ≥25 kg/m²; H-BMI; n?=?364) and non-overweight (BMI <25 kg/m²; N-BMI; n?=?932) patients were compared.

Results

Among these patients, 364 (28.1 %) were overweight. The OS was significantly higher in the H-BMI than N-BMI group (33.2 vs. 24.1 %, respectively; p?<?0.001). Preoperative and six-month postoperative BMIs were 27.1?±?2.0 and 24.8?±?2.0 kg/m², respectively, in the H-BMI group (p?<?0.001), whereas they were 21.7?±?2.2 and 20.7?±?2.2 kg/m², respectively, in the N-BMI group (p?=?0.007). There was significantly better differentiation (p?=?0.034), less distant metastases (p?=?0.006), and a lower metastatic lymph node ratio (p?=?0.014) observed in the H-BMI groups. Multivariate analyses indicated age, BMI, pathological tumor depth, distant metastases, metastatic lymph node ratio, and tumor size as independent prognostic factors.

Conclusions

Our findings suggest that overweight patients were less likely to have tumors with aggressive features and can achieve ideal body weight following curative gastrectomy, possibly resulting in better long-term prognosis     

Initial Japanese Experience with Intragastric Balloon Placement

Background

We introduced intragastric balloon placement in Japan and evaluated the initial data.

Methods

Between December 2004 and March 2008, intragastric balloons [BioEnterics® Intragastric Balloon (BIB®) system] were placed in 21 Japanese patients with obesity [six women, 15 men; mean age 40?±?9 years; mean body mass index (BMI) 40?±?9 kg/m²]. The inclusion criteria were morbid obesity (BMI?≥?35 kg/m²), the presence of obesity-related disorders, and failure with conventional treatments for at least 6 months. The balloon was routinely removed under endoscopy after 5 months.

Results

No serious complications occurred, but in two of the 21 patients (9.5%), early removal (within 1 week) of the balloon was required due to continuous abdominal discomfort. Two other patients (9.5%) could not control their eating behavior and were considered unresponsive to the treatment, and their balloons were also removed before 5 months. Seventeen of the 21 patients (81%) finished the treatment, and the average weight loss and percent excess weight loss (%EWL) at the time the balloons were removed were 12?±?5 kg and 27?±?9%, respectively. Eight patients were followed for 1 year without intervention of consecutive bariatric surgery, and at that time, four of these patients had kept more than 20% of %EWL. The other patients regained their weight in the first year.

Conclusions

Intragastric balloon placement is a safe and effective procedure in obese Japanese patients, and about half of the patients will maintain their weight loss after the balloon is removed.     

500 Intragastric Balloons: What Happens 5 Years Thereafter?

Background

The BioEnterics Intragastric Balloon (BIB) has been considered an effective, less invasive method for weight loss, as it provides a permanent sensation of satiety. However, various non-randomized studies suggest BIB is a temporary anti-obesity treatment, which induces only a short-term weight loss. The purpose of this study was to present data of 500 obese who, after BIB-induced weight reduction, were followed up for up to 5?years.

Methods

The BioEnterics BIB was used, and remained for 6?months. At 6, 12, and 24?months post-removal (and yearly thereafter), all subjects were contacted for follow-up.

Results

From 500 patients enrolled, 26 were excluded (treatment protocol interruption); 474 thus remained, having initial body weight of 126.16?±?28.32?kg, BMI of 43.73?±?8.39?kg/m², and excess weight (EW) of 61.35?±?25.41. At time of removal, 79 (17%) were excluded as having percent excessive weight loss (EWL) of <20%; the remaining 395 had weight loss of 23.91?±?9.08?kg (18.73%), BMI reduction of 8.34?±?3.14?kg/m² (18.82%), and percent EWL of 42.34?±?19.07. At 6 and 12?months, 387 (98%) and 352 (89%) presented with weight loss of 24.14?±?8.93 and 16.31?±?7.41?kg, BMI reduction of 8.41?±?3.10 and 5.67?±?2.55?kg/m², and percent EWL of 42.73?±?18.87 and 27.71?±?13.40, respectively. At 12 and 24?months, 187 (53%) and 96 (27%) of 352 continued to have percent EWL of >20. Finally, 195 of 474 who completed the 60-month follow-up presented weight loss of 7.26?±?5.41?kg, BMI reduction of 2.53?±?1.85?kg/m², and percent EWL of 12.97?±?8.54. At this time, 46 (23%) retained the percent EWL at >20. In general, those who lost 80% of the total weight lost during the first 3 months of treatment succeeded in maintaining a percent EWL of >20 long term after BIB removal: more precisely, this cutoff point was achieved in 83% at the time of removal and in 53%, 27%, and 23% at 12-, 24-, and 60-month follow-up.

Conclusion

BIB seems to be effective for significant weight loss and maintenance for a long period thereafter, under the absolute prerequisite of patient compliance and behavior change from the very early stages of treatment.     

Laparoscopic Gastric Bypass vs. Sleeve Gastrectomy in the Super Obese Patient: Early Outcomes of an Observational Study

Background

Super obesity [body mass index (BMI)?>?50 kg/m²] can yield to higher morbidity/mortality in bariatric surgery, this could be related to patient's characteristics and/or surgeon's experience. In morbid obesity, both techniques proved to have a positive impact and sometimes comparable outcomes during the first 2 years. This has not been clearly analyzed in the super obese patient.

Methods

Retrospective study comparing the records of 77 consecutive super obese patients (BMI: 50–59.9 kg/m²) submitted to either laparoscopic gastric bypass (LGBP, n?=?32) or laparoscopic sleeve gastrectomy (LSG, n?=?45) between 2010 and 2012 at a single institution. The primary objective was to analyze baseline demographics, comorbidities, operative outcomes, and early complications (<30 days). Secondarily, weight loss [BMI and % excess weight loss (%EWL)] was also described and compared during the first year.

Results

Female sex comprised 72.7 % of all cases. Both groups had comparable BMI (52.7?±?2.1 kg/m² for LGBP vs. 53.87?±?2.8 kg/m² for LSG; p?=?0.087) and homogeneous baseline characteristics. Operative time was lower for the LSG group (113.1?±?35.3 vs. 186.9?±?39 min for LGBP; p?≤?0.001). Overall, early complications were observed in 16.8 % of patients (LGBP 9 % vs. LSG 22 %; p?=?0.217). There were four major complications (two in each group), with two reinterventions. Weight loss (%EWL) at 6, 9, and 12 months was significantly higher in the LGBP group (51.6?±?12.9 %, 56.5?±?13 %, 63.9?±?13.3 %, respectively) than in the LSG group (40?±?12.8 %, 45.1?±?15.5 %, 43.9?±?10.4 %, respectively).

Conclusions

Just like in morbid obesity, LGBP and LSG are effective and safe procedures in super obese patients. LGBP had better weight loss at 1 year.     

Gastric Histopathology in Laparoscopic Sleeve Gastrectomy: Pre- and Post-Operative Comparison

Background

Sleeve gastrectomy (SG) produces excellent results in weight reduction and resolution of comorbidities. The histology of the gastric mucosa can be affected by the surgical procedure, with alterations of inflammatory patterns. The objective of this study is to evaluate alterations of the inflammatory patterns of the gastric mucosa in SG and the results in weight loss and resolution of comorbidities.

Methods

Morbidly obese patients were selected to undergo SG. Endoscopies were performed pre-operatively and post-operatively after 6 months, with an incisura and 3 cm before the pylorus biopsies. Data on weight, height, and associated diseases were collected. The data were compared, and the biopsies evaluate the inflammatory patterns.

Results

There was a reduction of body weight with a pre-operative weight of 132.5?±?15.7 kg and a post-operative weight of 95.8 ±10.6 kg with a p?<?0.001. Also, the body mass index (BMI) was reduced significantly with a mean pre-operative of 42.6?±?10.6 kg/m² and a post-operative of 30.9?±?3.2 kg/m² with a p?<?0.001. The comorbidities were all resolved or improved. The pattern of gastric histology showed chronic gastritis with inflammatory activity associated with Helicobacter pylori in 33.3 % of the patients, along with foveolar hyperplasia at 58.3 %. The chronic gastritis with discrete inflammatory activity was reduced by 16.7 %, and the foveolar hyperplasia was reduced by 33.3 %.

Conclusion

The inflammatory alterations in the pre-operative period were mainly foveolar hyperplasia and chronic gastritis associated with H. pylori, and they were reduced in the post-operative period. A significant reduction of weight and BMI occurred, and a resolution of comorbidities was observed.     

BioEnterics® Intragastric Balloon (BIB®). Single Ambulatory Center Spanish Experience with 714 Consecutive Patients Treated with One or Two Consecutive Balloons

Background

The BioEnterics® Intragastric Balloon (BIB®) is a well-established device for temporary treatment in morbidly obese patients. The aim of this study is the evaluation, in a population of 714 consecutive outpatient setting cases, BIB® results in terms of weight loss and comorbidity change.

Methods

BIB® was positioned in all cases after diagnostic endoscopy. The device was inflated under direct endoscopic vision with saline solution (600–700 ml) and methylene blue (10 ml). Intubation was carried out in patients with body mass index (BMI)?>?40 kg/m² affected by sleep apnea or chronic obstructive pulmonary disease. After 6 months, balloon removal was carried out, and patients were discharged with drug therapy and 1,000 kcal diet. More than 100 patients underwent a second consecutive balloon positioning. One month from the removal of the first BIB, patients were given a second BIB. Patients were followed up weekly. Mortality, complications and their treatment, postplacement symptoms, comorbidities, BMI, percentage of excess BMI loss (%EBL), and percentage of excess weight loss (%EWL) were considered. Data are expressed as mean?±?standard deviation.

Results

From June 1, 2005, to May 31, 2007, 714 patients underwent BIB® placement (143 males/571 females; mean age, 38.4?±?16.1; mean BMI, 37.6?±?5.7 kg/m²; mean EW, 56.3?±?27.1 kg). After 6 months, mean BMI was 31.1?±?7.2, mean %EWL was 41.6?±?21.8, mean BMI loss was 6.5?±?12.7, and mean %EBL was 44.5?±?22.6. Of 714 patients, 112 underwent a second BIB placement. At the time of the second balloon placement, mean BMI was 32.9?±?6.7 kg/m²; range was 31–51. After the second balloon removal, mean BMI was 30.3?±?7.2.

Conclusions

BIB® treatment is a safe and effective procedure for weight reduction, without mortality and with very low morbidity rates even in nonhospitalized patients. A second balloon can also be positioned without difficulties, achieving good results after 12 months of treatment.