Overview of developments in bariatric surgery in the Czech Republic and worldwide and new trends in bariatric-metabolic surgery.

Bariatric and metabolic surgery underwent substantial changes in its history. In the early nineties of the last century, the most important was introduction of laparoscopic procedures. Laparoscopic operations lead to worldwide adoption of bariatric surgery. Shift from bariatric to metabolic surgery represents another substantial change in treatment philosophy. In metabolic surgery, it is improvement/remission of metabolic parameters, such as type 2 diabetes mellitus and others, rather than weight loss what is the most important measure of success. Despite undoubtful success of surgical treatments, only a small proportion of the potentially eligible patients undergoes the operation. There are often fears of both patients and referring physicians of excessive invasiveness, risks and irreversible anatomical changes, mistrust in treatment results. Ongoing research targets these points, the goal is to master less invasive options than standard laparoscopic operations. Direct involvement of other medical specialties, such as gastroenterology or invasive radiology, in patient treatment is essential as well. Gastroenterology and endoscopic gastric plication, partial jejunal bypass and others may serve as the examples. Invasive radiology may offer potentially effective treatment modalities, such as embolization of left gastric artery. There's a trend in patients' preferences, towards less invasive treatment, even though it may result in moderate effectivity, rather than vice versa, choosing highly invasive, more risky treatment, regardless its expected higher efficacy.

Laparoscopic gastric plication in the treatment of obesity and metabolic disorders: 10-years results.

Laparoscopic gastric plication (LGCP) is a newer metabolic/bariatric surgical operation that requires no resection, no implantable device or bypass. We report outcomes in a cohort of LGCP patients at 10-year follow-up. Body mass index (BMI, kg/m2) evolution, total weight loss (%), and comorbidities were recorded. Repeated measures analysis of variance (ANOVA) was used to asses BMI change over 10 years. We have completed data of 86,9 % (109/125) of patients entering the study between 2009 and 2010, 21,6 % of all the patients were men. Mean age was 45,8 ±10,9 years, and mean baseline BMI was 42,1± 5,4 kg/m2. We observed still some weight reduction at 10 years. Hypertension and diabetes were the most frequent comorbidities. Incidence of diabetes decreased within ten years after the procedure, as well as the medication for diabetes decreased, on the other hand we observed no change in hyperlipoproteinemia. There were 16,8 % elective reoperations due to insufficient weight loss, out of that 19 % decided for malabsorptive procedure. There was no mortality or emergencies. At ten years follow-up, LGCP proved to be safe and effective method for obesity treatment.

Neudesin in obesity and type 2 diabetes mellitus: the effect of acute fasting and weight reducing interventions.

CONTEXT: Neudesin has recently been identified as a novel regulator of energy expenditure in experimental animals; however, its role in humans remains unexplored. OBJECTIVE: The aim of this study was to assess the effects of obesity and type 2 diabetes mellitus (T2DM) along with selected weight reducing interventions on serum neudesin levels and adipose tissue mRNA expression. PATIENTS AND METHODS: Fifteen obese subjects with T2DM undergoing endoscopic duodenal-jejunal bypass liner (DJBL) implantation, 17 obese subjects (11 with T2DM, 6 without T2DM) scheduled for gastric plication (GP), 15 subjects with functional hypoglycemia subjected to 72-hour acute fasting (AF), and 12 healthy controls were included in the study. RESULTS: Baseline neudesin levels were comparable between all groups. DJBL increased neudesin at 6 and 10 months after the procedure (1.77±0.86 vs 2.28±1.27 vs 2.13±1.02 ng/mL, P=0.001 for baseline vs 6 vs 10 months) along with reduction in body weight and improvement of HbA1c without any effect on neudesin mRNA expression in subcutaneous adipose tissue. Conversely, GP did not affect neudesin levels despite marked reduction in body weight and improvement of HbA1c. In contrast, AF decreased neudesin levels during the entire period (1.74±0.54 vs 1.46±0.48 ng/mL, P=0.001 for baseline vs 72 hours) with no impact of subsequent re-alimentation on neudesin concentrations. CONCLUSION: Neudesin levels are differentially regulated during AF and chronic weight reduction induced by DJBL or GP. Further studies are needed to assess its possible significance in energy homeostasis regulation in humans.

A novel approach to glycemic control in type 2 diabetes mellitus, partial jejunal diversion: pre-clinical to clinical pathway.

OBJECTIVE: To explore partial jejunal diversion (PJD) via a side-to-side jejuno-jejunostomy for improved glycemic control in type 2 diabetes mellitus (T2DM). PJD is an anatomy-sparing, technically simple surgery in comparison to the predominate metabolic procedures, Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). Positive results in a rodent model prompted a human proof-of-concept study. RESEARCH DESIGN AND METHODS: Pre-clinically, 71 rats were studied in a model of metabolic dysfunction induced by a high-fat diet; 33 animals undergoing one of two lengths of PJD were compared with 18 undergoing sham, 10 RYGB and 10 jejuno-ileal bypass. Clinically, 15 adult subjects with treated but inadequately controlled T2DM (hemoglobin A1c (HbA1c) of 8.0%-11.0%), body mass index of 27.0-40.0 kg/m2, and C peptide ≥3 ng/mL were studied. Follow-up was at 2 weeks, and 3, 6, 9, and 12 months post-PJD. RESULTS: Pre-clinically, positive impacts with PJD on glucose homeostasis, cholesterol, and body composition versus sham control were demonstrated. Clinically, PJD was performed successfully without serious complications. Twelve months post-surgery, the mean (SD) reduction from baseline in HbA1c was 2.3% (1.3) (p<0.01). CONCLUSIONS: PJD may provide an anatomy sparing, low-risk, intervention for poorly controlled T2DM without significant alteration of the patient's lifestyle. The proof-of-concept study is limited by a small sample size and advanced disease, with 80% of participants on insulin and a mean time since diagnosis of over 10 years. Further study is warranted. TRIAL REGISTRATION NUMBER: NCT02283632; Pre-results.

Insulin Sensitivity and Secretion in Obese Type 2 Diabetic Women after Various Bariatric Operations.

OBJECTIVE: To compare the effects of biliopancreatic diversion (BPD) and laparoscopic gastric banding (LAGB) on insulin sensitivity and secretion with the effects of laparoscopic gastric plication (P). METHODS: A total of 52 obese women (age 30-66 years) suffering from type 2 diabetes mellitus (T2DM) were prospectively recruited into three study groups: 16 BPD; 16 LAGB, and 20 P. Euglycemic clamps and mixed meal tolerance tests were performed before, at 1 month and at 6 months after bariatric surgery. Beta cell function derived from the meal test parameters was evaluated using mathematical modeling. RESULTS: Glucose disposal per kilogram of fat free mass (a marker of peripheral insulin sensitivity) increased significantly in all groups, especially after 1 month. Basal insulin secretion decreased significantly after all three types of operations, with the most marked decrease after BPD compared with P and LAGB. Total insulin secretion decreased significantly only following the BPD. Beta cell glucose sensitivity did not change significantly post-surgery in any of the study groups. CONCLUSION: We documented similar improvement in insulin sensitivity in obese T2DM women after all three study operations during the 6-month postoperative follow-up. Notably, only BPD led to decreased demand on beta cells (decreased integrated insulin secretion), but without increasing the beta cell glucose sensitivity.

Laparoscopic greater curvature plication in morbidly obese women with type 2 diabetes: effects on glucose homeostasis, postprandial triglyceridemia and selected gut hormones.

BACKGROUND: Laparoscopic greater curvature plication (LGCP) is an emerging bariatric procedure that reduces the gastric volume without implantable devices or gastrectomy. The aim of this study was to explore changes in glucose homeostasis, postprandial triglyceridemia, and meal-stimulated secretion of selected gut hormones [glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), ghrelin, and obestatin] in patients with type 2 diabetes mellitus (T2DM) at 1 and 6 months after the procedure. METHODS: Thirteen morbidly obese T2DM women (mean age, 53.2 ± 8.76 years; body mass index, 40.1 ± 4.59 kg/m2) were prospectively investigated before the LGCP and at 1- and 6-month follow-up. At these time points, all study patients underwent a standardized liquid mixed-meal test, and blood was sampled for assessment of plasma levels of glucose, insulin, C-peptide, triglycerides, GIP, GLP-1, ghrelin, and obestatin. RESULTS: All patients had significant weight loss both at 1 and 6 months after the LGCP (p ≤ 0.002), with mean percent excess weight loss (%EWL) reaching 29.7 ± 2.9% at the 6-month follow-up. Fasting hyperglycemia and hyperinsulinemia improved significantly at 6 months after the LGCP (p < 0.05), with parallel improvement in insulin sensitivity and HbA1c levels (p < 0.0001). Meal-induced glucose plasma levels were significantly lower at 6 months after the LGCP (p < 0.0001), and postprandial triglyceridemia was also ameliorated at the 6-month follow-up (p < 0.001). Postprandial GIP plasma levels were significantly increased both at 1 and 6 months after the LGCP (p < 0.0001), whereas the overall meal-induced GLP-1 response was not significantly changed after the procedure (p > 0.05). Postprandial ghrelin plasma levels decreased at 1 and 6 months after the LGCP (p < 0.0001) with no significant changes in circulating obestatin levels. CONCLUSION: During the initial 6-month postoperative period, LGCP induces significant weight loss and improves the metabolic profile of morbidly obese T2DM patients, while it also decreases circulating postprandial ghrelin levels and increases the meal-induced GIP response.

Adjustable gastric banding outcomes with and without gastrogastric imbrication sutures: a randomized controlled trial.

BACKGROUND: The intended purpose of gastrogastric imbrication sutures in laparoscopic adjustable gastric banding is to reduce band-related complications; however, evidence demonstrating imbrication suture utility has been lacking. A 3-year randomized controlled trial on the safety and efficacy of laparoscopic adjustable gastric banding with and without imbrication sutures was undertaken. We performed a prospective investigation of the outcomes using the Swedish adjustable gastric band (SAGB) with and without imbrication sutures. METHODS: From January to September 2006, 100 patients undergoing SAGB placement were randomized to group 1 (n = 50, ≥ 2 imbrication sutures) or group 2 (n = 50, no imbrication sutures). The SAGB was implanted in both groups using a standardized pars flaccida technique. The mean operative time, hospitalization time, percentage of excess weight loss, body mass index, band fill volume, and complications were recorded. The Fisher exact test for categorical data, the independent samples t test for continuous data, and the paired t test to assess the body mass index reduction were performed. All tests were 2-tailed, and statistical significance was set at P <.05. RESULTS: The mean operative time was 75 ± 7 minutes (range 50-92) and 48 ± 4 minutes (range 32-75) for groups 1 and 2, respectively (P <.001). The mean hospitalization time was 26 ± 12 hours (range 20-96) and 23 ± 9 hours (range 20-48) for groups 1 and 2, respectively (P <.17). The 3-year percentage of excess weight loss was 55.7% ± 3.4% and 58.1% ± 4.1% for groups 1 and 2, respectively (95% confidence interval -4.0% to -.8%, P <.01). The body mass index at 3 years was 34.0 ± 5.8 kg/m(2) and 30.3 ± 6.4 kg/m(2) (range 1.2-6.2) for groups 1 and 2, respectively (P <.01). The fill volume at 3 years was 3.6 ± 1.2 mL (range 1.0-5.5) and 4.5 ± 0.5 mL (range .0-5.0) for groups 1 and 2, respectively (P <.01). Finally, slippage occurred in 1 patient (2.2%) and 1 patient (2.0%) and migration in 1 patient (2.2%) and 1 patient (2.0%) in groups 1 and 2, respectively (P = NS). No patient died in either group. CONCLUSION: The results of our randomized controlled trial have demonstrated that SAGB combined with a conservative approach to band adjustments and limited retrogastric dissection is effective and safe with and without imbrication sutures. Not using imbrication sutures results in significant benefits in operative speed with comparable clinical weight loss and intermediate term safety. These randomized controlled trial data suggest that imbrication sutures are not indispensable to laparoscopic adjustable gastric banding and their use can be left to the surgeon's discretion.

The relationship between esophageal peristalsis and in vivo intraband pressure measurements in gastric banding patients.

Intraband pressure (IBP) measurement may be a less invasive method to assess esophageal motility response to band adjustment and restrictive integrity of the device in Swedish adjustable gastric band (SAGB) patients. However, the relationship between IBP and esophageal function is not yet established. Our aim was to characterize in vivo IBP-peristalsis associations in SAGB patients. Ten patients in their second postoperative year were prospectively recruited. IBP was measured via percutaneous port, and concurrent esophageal manometry was performed using an 8-channel catheter. Contraction length and amplitude were measured with both methods. The IBP-peristalsis correlation was computed using the R-square of the regression analysis (R (2)) for band volumes ranging from 4 to 9 mL. One hundred ten swallows were studied. Excellent IBP-peristalsis correlation was observed in 6 of 10 patients (267 contractions): contraction length R (2) = 0.8537 and amplitude R (2) = 0.7365 (p-value of slope < 0.001). Mean contraction length was 17 +/- 7 (4-42) s for manometry and 18 +/- 7 (5-43) s for IBP. Mean amplitude was 55 +/- 55 (9-209) mm Hg for manometry and 67 +/- 47 (7-190) mm Hg for IBP. A weak IBP-peristalsis correlation was observed in the remaining four patients: two had impaired lower sphincter relaxation, one had band slippage, and one had disruption of the port needle connection. In vivo IBP measurement may be reliable in the assessment of esophageal peristalsis in response to band adjustments and the restrictive integrity of the device in patients with intact esophageal function. More studies are warranted to completely assess the potential for IBP to be indicative of the presence of band-related complications.

Validity of the Czech, German, Italian, and Spanish version of the Moorehead-Ardelt II questionnaire in patients with morbid obesity.

BACKGROUND: The Moorehead-Ardelt II (MA-II) questionnaire is the most frequently applied instrument to assess quality of life (QoL) in bariatric surgery patients. Our aim was to validate the Czech, German, Italian, and Spanish version of the MA-II. METHODS: A total of 893 patients were enroled in a prospective cross-sectional European study. Two thirds of the patients(n = 591) were postsurgical cases. In addition to demographicand clinical data, QoL data was collected using the MA-II questionnaire, the EuroQoL-5D (EQ-5D), and the Short Form 36 Health Survery (SF-36). Statistical parameters for contingency (Cronbach's alpha), construct and criterion validity(Pearson's r), and responsiveness (standardised effect sizes) were calculated for each language version. RESULTS: In the different languages, Cronbach's alpha ranged from 0.817 to 0.885 for the MA-II. These values were higher than those obtained for the SF-36 (0.418-0.607). The MA-II was well correlated to the EQ-5D (r = 0.662) and to 3 of the 8 health domains of the SF-36 (0.615, 0.548, and 0.569 for physical functioning,physical role, and general health, respectively). As expected, there was a negative correlation between the MA-II and the BMI (r = -0.404 for all patients), but no significant correlation with age was found.When comparing both the heaviest and the lightest third of the patients, mean responsiveness was higher for the MA-II (-1.138) than for the domains of the SF-36 (range -0.111 to -1.070) and the EQ-5D (-0.874). CONCLUSION: The Czech, German, Italian, and Spanish version of the MA-II questionnaire are valid instruments and should be preferred to generic questionnaires as they provide better responsiveness.

Mapping utility scores from a disease-specific quality-of-life measure in bariatric surgery patients.

OBJECTIVES: To develop algorithms for a conversion of disease-specific quality-of-life into health state values for morbidly obese patients before or after bariatric surgery. METHODS: A total of 893 patients were enrolled in a prospective cross-sectional multicenter study. In addition to demographic and clinical data, health-related quality-of-life (HRQoL) data were collected using the disease-specific Moorehead-Ardelt II questionnaire (MA-II) and two generic questionnaires, the EuroQoL-5D (EQ-5D) and the Short Form-6D (SF-6D). Multiple regression models were constructed to predict EQ-5D- and SF-6D-based utility values from MA-II scores and additional demographic variables. RESULTS: The mean body mass index was 39.4, and 591 patients (66%) had already undergone surgery. The average EQ-5D and SF-6D scores were 0.830 and 0.699. The MA-IIwas correlated to both utility measures (Spearman's r = 0.677 and 0.741). Goodness-of-fit was highest (R(2) = 0.55 in the validation sample) for the following item-based transformation algorithm: utility (MA-II-based) = 0.4293 + (0.0336 x MA1) + (0.0071 x MA2) + (0.0053 x MA3) + (0.0107 x MA4) + (0.0001 x MA5). This EQ-5D-based mapping algorithm outperformed a similar SF-6D-based algorithm in terms of mean absolute percentage error (P = 0.045). CONCLUSIONS: Because the mapping algorithm estimated utilities with only minor errors, it appears to be a valid method for calculating health state values in cost-utility analyses. The algorithm will help to define the role of bariatric surgery in morbid obesity.