Y Not Roux-en-Y?: Resolution of Barrett's Esophagus After Surgical Conversion of Gastric Sleeve in Two Patients.

Esophageal lesions ranging from erosive esophagitis to Barrett's esophagus (BE) eventually develop months-years after sleeve gastrectomy (SG), representing a significant post-surgical issue in GI practice. Roux-en-Y gastric bypass (RYGB) conversion is a widespread and effective method of managing reflux and esophageal complications following SG. Although some studies using a limited sample size have demonstrated that RYGB performed as a primary procedure may regress BE presumably by reducing reflux, whether the same may apply to RYGB performed as revision surgery after SG has scarcely been addressed in the literature. Though histological regression of BE following primary RYGB occurs in 51.9% of patients, with regression of Barrett's dysplasia in 50% of cases, revisional RYGB yields a remission rate as high as 81.8% for Barrett's metaplasia and 100% for dysplastic lesions, although the number of subjects in the published studies are very small. We report two patients who developed GERD and BE following SG with complete regression 12 months after conversion to RYGB in both subjects, confirming the substantially greater proportion of BE resolution in patients undergoing RYGB as revision surgery following SG.

GORD and Barrett's oesophagus after bariatric procedures: multicentre prospective study.

INTRODUCTION: Gastro-oesophageal reflux disease (GORD) after bariatric surgery is a debated topic. This study investigated the prevalence of GORD and associated oesophageal complications following bariatric procedures-namely, adjustable gastric banding (AGB), sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one-anastomosis gastric bypass (OAGB). METHODS: This was a prospective multicentre study designed to evaluate the long-term effects of bariatric surgery on GORD. Patients were studied at baseline, at >10 years following AGB, SG, and RYGB, and at >3 years following OAGB (due to the more recent recognition of OAGB as a standard bariatric procedure). Patients were assessed by endoscopy and GORD symptom evaluation. RESULTS: A total of 241 patients were enrolled. A minimum follow-up of 10 years was completed by 193 patients following AGB (57 patients), SG (95 patients), and RYGB (41 patients), and of >3 years by 48 subjects following OAGB. GORD symptoms increased following AGB and SG (from 14 to 31.6 per cent and from 26.3 to 58.9 per cent, respectively; P < 0.0001), improved following RYGB (from 36.6 to 14.6 per cent; P < 0.0001), and were unchanged following OAGB. The overall prevalence of erosive oesophagitis was greater in the SG group (74.7 per cent) than in the AGB (42.1 per cent), RYGB (22 per cent), and OAGB (22.9 per cent) groups (P < 0.0001). Barrett's oesophagus was found only in patients who had SG (16.8 per cent). Biliary-like gastric stagnation was found in a greater proportion of SG and OAGB patients (79.7 and 69.4 per cent, respectively) than in other treatment groups (P < 0.0001). The prevalence of biliary-type reflux into the oesophagus was higher in patients who underwent SG (74.7 per cent), compared with other treatment groups. CONCLUSION: Bariatric surgery leads to gastro-oesophageal complications of variable severity, particularly SG, which can result in a large proportion of patients developing Barrett's oesophagus.

Gastro-oesophageal reflux disease (GORD)-related oesophageal sequelae following bariatric surgery confirm the importance of postoperative endoscopic surveillance in early detection of such conditions. Sleeve gastrectomy was shown to be correlated with the highest prevalence of GORD, biliary-type gastric and oesophageal reflux, and erosive oesophagitis. This, in turn, appeared to be responsible for the high number of cases of Barrett's oesophagus found in this group of patients. Adjustable gastric banding displayed minimal effectiveness in terms of weight loss, along with a high number of reoperations, also due to band-related complications. The study showed one-anastomosis gastric bypass to be associated with a high percentage of subjects who developed often severe inflammation of the gastrojejunal anastomosis or of the gastric pouch, as a consequence of chronic biliary-type duodenogastric reflux. Finally, our results suggest that Roux-en-Y gastric bypass could represent the most 'reliable' bariatric procedure in terms of GORD resolution, and the only operation not requiring any reintervention in our cohort of patients. Each surgical procedure leads to gastro-oesophageal modifications of variable extent, which need to be taken into consideration when selecting the designated bariatric operation.

Learning curve for laparoscopic sleeve gastrectomy: role of training in a high-volume bariatric center.

BACKGROUND: Since the great diffusion of laparoscopic treatment of obesity, there is a growing interest concerning the learning process for those surgeons who undertake the bariatric activity. However, papers analyzing the learning curve (LC) for sleeve gastrectomy (SG) are still scarce. This study aims to investigate whether the LC for SG of a novice bariatric surgeon might be positively influenced by the training in a high-volume bariatric center (HVBC). METHODS: Between October 2010 and January 2014, 128 patients underwent SG by the same young surgeon who previously attended a 2-year training in a HVBC. His LC has been divided into three consecutive periods: in the first period (1st-47th SGs) he operated in the HVBC, while in the second (48th-88th SGs) and third period (89th-128th SGs) he moved to a novel department where surgical and ancillary staff were initially not confident with bariatric procedures but progressively owned the proper experience. Preoperative characteristics, operative data, complications and postoperative results of the three periods were compared. RESULTS: Mean follow-up was 1 year. Preoperative patients' characteristics were homogeneous. No significant differences have been registered among the three periods concerning operative data, mortality, intra- and post-operative complications, weight loss outcomes and comorbidities' resolution. Post-operative follow-up rates at 6 and 12 months were 98.4 and 92.1 %, respectively. CONCLUSIONS: Long-lasting fellowship in a HVBC might allow the novel bariatric surgeon to safely and proficiently overcome the LC for SG, even in a new established bariatric setting.

Intragastric balloon for obesity treatment: results of a multicentric evaluation for balloons left in place for more than 6 months.

BACKGROUND: Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months. MATERIALS AND METHODS: A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. RESULTS: Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. CONCLUSION: Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.

Upcoming Italian clinical practice guidelines on endoscopic bariatric treatment of overweight and obesity: design and methodological aspects.

Obesity/overweight and its complications are a growing problem in many countries. Italian Society of Bariatric and Metabolic Surgery for Obesity (Società Italiana di Chirurgia dell'Obesità e delle Malattie Metaboliche-SICOB) decided to develop the first Italian guidelines for the endoscopic bariatric treatment of obesity. The creation of SICOB Guidelines is based on an extended work made by a panel of 44 members and a coordinator. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology has been used to decide the aims, reference population, and target health professionals. Clinical questions have been created using the PICO (patient, intervention, comparison, outcome) conceptual framework. We will perform systematic reviews, formal meta-analyses, and network meta-analyses for each PICO and critical outcomes aimed at assessing and rating the efficacy and safety of endoscopic bariatric procedures in comparison with either no interventions, lifestyle interventions, or approved anti-obesity treatments in trials with a follow-up of at least 52 weeks. For PICO on temporary endoscopic bariatric treatments, we will also consider RCT with a minimum duration of 6 months. The panel proposed 8 questions, organized into four domains: A. Indication for endoscopic bariatric surgery; B. Revisional surgery; C. Temporary gastric and duodenal-jejunal procedures; D. Endoscopic diagnosis/treatment of bariatric and metabolic surgery complications. These guidelines will apply to patients aged ≥ 14 years) with body mass index (BMI) ≥ 27 kg/m2 and requiring endoscopic bariatric surgery or endoscopic diagnostic and/or therapeutic procedures. The areas covered by the clinical questions included indications of endoscopic bariatric surgery, types of surgery, revisional surgery, and management of bariatric and metabolic surgery complications.

Efficacy of Sleeve Gastrectomy with Concomitant Hiatal Hernia Repair versus Sleeve-Fundoplication on Gastroesophageal Reflux Disease Resolution: Systematic Review and Meta-Analysis.

(1) Background: There is still disagreement over how sleeve gastrectomy (SG) affects gastroesophageal reflux disease (GERD). The debate regarding the best option for patients undergoing bariatric surgery who are also affected by GERD and/or hiatal hernia continues to divide the community of bariatric surgeons. While concomitant hiatal hernia repair (SG + HHR) has been proposed as a means of reducing the risk of GERD following SG with varying degrees of success, the addition of a fundoplication (SG + FP) has been suggested in recent years as a way to improve the lower esophageal sphincter's competency. The aim of this study is to systematically review and meta-analyze the efficacy of SG + HHR versus SG + FP on GERD remission in patients with obesity. (2) Methods: A systematic review of the literature was conducted, and studies analyzing the effects of SG + HHR versus SG + FP on postoperative GERD were included. The methodological quality of included trials was evaluated. The primary outcome was postoperative GERD rate, erosive esophagitis, and 12-month weight loss. Secondary outcomes included postoperative complications and mortality. The PRISMA guidelines were used to carry out the present systematic review (PROSPERO Registration Number: CRD42023405600). (3) Results: Fifteen articles with a total of 1164 patients were included in the meta-analysis; 554 patients underwent SG + HHR while 610 underwent SG + FP. In the SG + HHR group, 58.5 ± 28.9% of subjects presented clinical GERD symptoms compared to 20.4 ± 17.5% postoperatively (p < 0.001). In the SG + FP group, 64.8 ± 39.4% were affected by GERD preoperatively compared to only 5 ± 8.1% postoperatively (p < 0.001). SG + FP patients had a significantly greater GERD remission compared to SG + HHR (p < 0.001). Weight loss was similar between groups (p = 0.125). The rate of leaks was 0.18% and 0.33% in the SG + HHR and SG + FP, respectively (p = 0.657), while perforations were significantly higher after SG + FP compared to the SG + HHR group (3.1% versus 0%, p = 0.002). The mortality rate was significantly greater in the SG + FP group (0.5% versus 0%, p = 0.002). (4) Conclusions: This study revealed that both SG with concomitant HHR and sleeve-fundoplication are effective in terms of reflux resolution and weight outcomes, with superiority of SG + FP in terms of GERD control, despite a greater overall complication rate. Both strategies can therefore be suggested as a suitable alternative variant to a conventional SG in subjects with obesity and concomitant hiatal hernia and/or GERD. Studies with extended follow-up and direct comparisons of these surgical approaches to conventional SG are warranted.

Predictors of weight loss in patients with obesity treated with a Very Low-Calorie Ketogenic Diet.

Introduction: The Very Low-Calorie Ketogenic Diet (VLCKD) has emerged as a safe and effective intervention for the management of metabolic disease. Studies examining weight loss predictors are scarce and none has investigated such factors upon VLCKD treatment. Among the molecules involved in energy homeostasis and, more specifically, in metabolic changes induced by ketogenic diets, Fibroblast Growth Factor 21 (FGF21) is a hepatokine with physiology that is still unclear. Methods: We evaluated the impact of a VLCKD on weight loss and metabolic parameters and assessed weight loss predictors, including FGF21. VLCKD is a severely restricted diet (<800 Kcal/die), characterized by a very low carbohydrate intake (<50 g/day), 1.2-1.5 g protein/kg of ideal body weight and 15-30 g of fat/day. We treated 34 patients with obesity with a VLCKD for 45 days. Anthropometric parameters, body composition, and blood and urine chemistry were measured before and after treatment. Results: We found a significant improvement in body weight and composition and most metabolic parameters. Circulating FGF21 decreased significantly after the VLCKD [194.0 (137.6-284.6) to 167.8 (90.9-281.5) p < 0.001] and greater weight loss was predicted by lower baseline FGF21 (Beta = -0.410; p = 0.012), male sex (Beta = 0.472; p = 0.011), and central obesity (Beta = 0.481; p = 0.005). Discussion: VLCKD is a safe and effective treatment for obesity and obesity related metabolic derangements. Men with central obesity and lower circulating FGF21 may benefit more than others in terms of weight loss obtained following this diet. Further studies investigating whether this is specific to this diet or to any caloric restriction are warranted.

Intragastric balloon positioning and removal: sedation or general anesthesia?

BACKGROUND: Different anesthesiological techniques are currently used for intragastric balloon positioning and removal. The aim of this study is to compare different anesthesiological approaches for balloon positioning and removal in a large multicentric patient population. METHODS: Retrospective multicenter study was conducted. From May 2000 to April 2008, 3,824 patients underwent BIB(®) placement [1,022 male/2,802 female; mean age 39.5 ± 14.7 years, range 12-71 years; mean body mass index (BMI) 44.8 ± 9.7 kg/m(2), range 28.0-79.1 kg/m(2); excess weight (EW) 59.1 ± 29.8 kg, range 16-210 kg; %EW 89.3 ± 31.7, range 21.4-262]. Patients were allocated to three groups according to anesthesiological technique used: conscious sedation (group A), deep sedation (group B), and general anesthesia (group C). Intragastric balloon was placed after diagnostic endoscopy and removed after 6 months. Both positioning and removal were done under different protocols. Conscious sedation was obtained with topical lidocaine spray, adding diazepam (0.05-0.1 mg/kg iv) or midazolam (0.03-0.05 mg/kg iv). Deep sedation was obtained with propofol alone or adding other drugs such as midazolam, meperidine/fentanyl or meperidine/fentanyl + midazolam. General anesthesia was obtained with midazolam premedication (0.01-0.02 mg/kg iv) followed by induction with propofol (1-1.5 mg/kg iv) + Norcuron (80 mcg/kg iv) + fentanyl (0.5-1 mcg/kg iv), and maintenance with propofol (50-150 µg/kg/min) or sevorane. Oxygen saturation, hemodynamic stability, major anesthesiological complications and related mortality, patient satisfaction, time to return to autonomous walking, duration of procedure, and hospital stay were considered. RESULTS: Sedation-related mortality was absent. A significant number of patients with bronchoinhalation during balloon removal was observed with general anesthesia (P < 0.001). CONCLUSIONS: BIB positioning and removal should be performed under conscious sedation for patient safety and comfort, and technical success.

Esophageal adenocarcinoma after sleeve gastrectomy: actual or potential threat? Italian series and literature review.

BACKGROUND: Sleeve gastrectomy (SG) leads to esophageal mucosal damage in an elevated percentage of cases, configuring a clinical condition of Barrett's esophagus (BE) in a proportion as high as 15-18.8%. BE may rarely evolve into esophageal adenocarcinoma (EAC). OBJECTIVES: To raise awareness of BE as a precancerous lesion which may progress toward malignancy after this popular bariatric procedure. SETTING: Bariatric referral centers, Italy. METHODS: All patients referred to our bariatric center who developed an EAC after SG between 2012 and 2019 were reviewed and consecutively included in this study. The available scientific literature regarding this complication is additionally reviewed. RESULTS: The 3 male patients comprised in this case series underwent laparoscopic SG between 2012 and 2015 in different bariatric referral centers. Age and body mass index at baseline ranged from 21-54 years and 43.1-75.6 kg/m2, respectively. All patients were lost to follow-up early after surgery (3.7 ± 1.4 months), and were diagnosed with EAC at a mean of 27.3 ± 7.6 months after SG. The 4 reported cases in the scientific literature developed an EAC at a mean of 32.5 ± 23 months from SG. Overall, a diagnosis of EAC was made approximately 30.3 ± 17.1 months postoperatively, which seems relatively and worryingly early after surgery. CONCLUSION: Although the rate and probability of progression from BE to EAC is still not well defined, assuming that the rising popularity and execution of SG leads to a growth in the BE incidence, then the preoperative identification and stratification of cancer risk factors in this subset of patients is strongly encouraged. Clinical and endoscopic follow-ups are essential to allow for prevention and early diagnosis and for epidemiologic data collection purposes.

Gastroesophageal Reflux Disease - Health-Related Quality of Life Questionnaire: prospective development and validation in Italian.

OBJECTIVE: To date, two questionnaires investigating the symptoms of gastroesophageal reflux disease (GERD) (Quality of Life Reflux and Dyspepsia and Reflux Disease Questionnaire) are validated in Italian, but neither of the two questionnaires was correlated with an instrumental examination. The aim of the present study is to improve the GERD-Health Related Quality of Life (HRQL) questionnaire, to evaluate the reliability and validity of its Italian translation, and its sensitivity and specificity. METHODS: A modified Italian GERD-HRQL (MI-GERD-HRQL) questionnaire was developed adding six questions investigating on regurgitation, for a total of 15 questions. The forward-backward translation process was employed to obtain a definitive from-English-to-Italian version. Data obtained from the questionnaire were compared to upper gastrointestinal endoscopy findings. RESULTS: The questionnaire was administered twice to 130 Italian-speaking patients by two different and independent raters. Cronbach's α of the first and second questionnaire was 0.944 and 0.942, respectively. Spearman correlation and inter-rater reliability were 0.923 and 0.929, respectively. Sensitivity and specificity were 73.3 and 64%, and 69.5 and 64%, respectively, for the first and second questionnaire. CONCLUSION: The MI-GERD-HRQL questionnaire proved good consistency, reliability, sensitivity and specificity in the evaluation of typical GERD symptoms.

Sleeve gastrectomy and gastroesophageal reflux: a comprehensive endoscopic and pH-manometric prospective study.

BACKGROUND: The impact of sleeve gastrectomy (SG) on gastroesophageal reflux disease (GERD) is still greatly debated. Most of the current evidence available is solely based on symptom evaluation or medication use, while a minority have implemented objective functional measurements. OBJECTIVE: To better comprehend the pathophysiological mechanisms involved in the genesis of GERD after SG. SETTING: University Hospital, Italy. METHODS: A total of 21 patients affected by morbid obesity and eligible for SG were prospectively enrolled in the present study. Patients were evaluated by means of endoscopy, high-resolution manometry (HRM), 24-hour pH monitoring, and the Gastroesophageal Reflux Disease Health-Related Quality of Life questionnaire. RESULTS: Follow-up was completed at least 1 year post operation (mean follow-up, 14.3 ± 2.1 mo) by 19 patients. Body mass index decreased from 41.2 ± .9 to 26.8 ± .8 kg/m2 (P < .001). Distal contractile integral significantly decreased from 2772.8 ± 399.9 mm Hg/s/cm to 2060.4 ± 338.9 mm Hg/s/cm (P = .01). The 24-hour pH monitoring showed an overall reduction tendency of acid reflux, although this was not statistically significant. All analyzed endoscopic findings withstood substantial pejorative modifications after SG (P < .01). Distal contractile integral values at baseline predicted postoperative Z-line upward migration; HRM, distal latency, and DeMeester score at baseline predicted the development of erosive esophagitis at follow-up, by bootstrap estimates of a logistic regression. CONCLUSIONS: Postoperative GERD-related esophageal sequelae should be carefully considered after SG. Our results demonstrate how acid reflux does not seem to play a relevant role in the pathophysiology of post-SG GERD. Baseline HRM can help stratify the risk of developing erosive esophagitis and Z-line upward migration after SG, while postoperative endoscopic surveillance should be encouraged regardless of the presence or absence of symptoms.

Scientific evidence underlying contraindications to the ketogenic diet: An update.

First identified as a feasible treatment for intractable epilepsy, the ketogenic diet (KD) has recently gained popularity thanks to growing evidence on applications such as weight loss, most importantly, but also NAFLD, cancer, neurologic conditions and chronic pain. As with any treatment, whether pharmacologic or not, the KD might not be an appropriate intervention for every individual, and a number of contraindications have been proposed, now deeply rooted into clinical practice, excluding de facto many patients that could benefit from its use. However, many of these concerns were expressed due to the absence of clinical studies conducted on fragile populations, and an assessment of lately emerged evidence relative to KD safety is currently lacking and much needed. We herein provide a critical revision of the literature behind each safety alert, in order to guide through the treatment options in the case of subjects with an indication to the KD and a borderline safe situation. Based on available evidence, the possible use of this diet as a therapeutic intervention should be assessed on a patient-to-patient basis by adequately skilled medical doctors, keeping in mind current recommendations, but reading them through the knowledge of the current state of the art.

Baseline HOMA IR and Circulating FGF21 Levels Predict NAFLD Improvement in Patients Undergoing a Low Carbohydrate Dietary Intervention for Weight Loss: A Prospective Observational Pilot Study.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a major cause of liver disease. Very low-calorie ketogenic diets (VLCKD) represent a feasible treatment as they induce profound weight loss and insulin resistance (IR) improvement. Despite the recognized benefits on NAFLD deriving from pharmacological administration of fibroblast growth factor 21 (FGF21), whose endogenous counterpart is a marker of liver injury, little is known about its physiology in humans. AIM: To identify predictors of NAFLD improvement as reflected by the reduction of the non-invasive screening tool hepatic steatosis index (HSI) in obese patients undergoing a weight loss program. METHODS: Sixty-five obese patients underwent a 90-day dietary program consisting of a VLCKD followed by a hypocaloric low carbohydrate diet (LCD). Anthropometric parameters, body composition, and blood and urine chemistry were assessed. RESULTS: Unlike most parameters improving mainly during the VLCKD, the deepest HSI change was observed after the LCD (p = 0.02 and p < 0.0001, respectively). Baseline HOMA-IR and serum FGF21 were found to be positive (R = 0.414, p = 0009) and negative (R = 0.364, p = 0.04) independent predictors of HSI reduction, respectively. CONCLUSIONS: We suggest that patients with IR and NAFLD derive greater benefit from a VLCKD, and we propose a possible role of human FGF21 in mediating NAFLD amelioration following nutritional manipulation.

Very-Low-Calorie Ketogenic Diets With Whey, Vegetable, or Animal Protein in Patients With Obesity: A Randomized Pilot Study.

CONTEXT: We compared the efficacy, safety, and effect of 45-day isocaloric very-low-calorie ketogenic diets (VLCKDs) incorporating whey, vegetable, or animal protein on the microbiota in patients with obesity and insulin resistance to test the hypothesis that protein source may modulate the response to VLCKD interventions. SUBJECTS AND METHODS: Forty-eight patients with obesity (19 males and 29 females, homeostatic model assessment (HOMA) index ≥ 2.5, aged 56.2 ± 6.1 years, body mass index [BMI] 35.9 ± 4.1 kg/m2) were randomly assigned to three 45-day isocaloric VLCKD regimens (≤800 kcal/day) containing whey, plant, or animal protein. Anthropometric indexes; blood and urine chemistry, including parameters of kidney, liver, glucose, and lipid metabolism; body composition; muscle strength; and taxonomic composition of the gut microbiome were assessed. Adverse events were also recorded. RESULTS: Body weight, BMI, blood pressure, waist circumference, HOMA index, insulin, and total and low-density lipoprotein cholesterol decreased in all patients. Patients who consumed whey protein had a more pronounced improvement in muscle strength. The markers of renal function worsened slightly in the animal protein group. A decrease in the relative abundance of Firmicutes and an increase in Bacteroidetes were observed after the consumption of VLCKDs. This pattern was less pronounced in patients consuming animal protein. CONCLUSIONS: VLCKDs led to significant weight loss and a striking improvement in metabolic parameters over a 45-day period. VLCKDs based on whey or vegetable protein have a safer profile and result in a healthier microbiota composition than those containing animal proteins. VLCKDs incorporating whey protein are more effective in maintaining muscle performance.

Publisher Correction: New insight into the mechanisms of ectopic fat deposition improvement after bariatric surgery.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

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/m(2) and 54.8 +/- 2.5 (range 45.1-56.2) kg/m(2) in BIB and LSG groups, respectively. At 6-month follow-up, mean BMI was 46.2 +/- 3.5 and 45.3 +/- 5.5 kg/m(2) 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).

New insight into the mechanisms of ectopic fat deposition improvement after bariatric surgery.

Non-alcoholic fatty-liver disease (NAFLD) is frequent in obese patients and represents a major risk factor for the development of diabetes and its complications. Bariatric surgery reverses the hepatic features of NAFLD. However, its mechanism of action remains elusive. We performed a comprehensive analysis of the mechanism leading to the improvement of NAFLD and insulin resistance in both obese rodents and humans following sleeve-gastrectomy (SG). SG improved insulin sensitivity and reduced hepatic and monocyte fat accumulation. Importantly, fat accumulation in monocytes was well comparable to that in hepatocytes, suggesting that Plin2 levels in monocytes might be a non-invasive marker for the diagnosis of NAFLD. Both in vitro and in vivo studies demonstrated an effective metabolic regeneration of liver function and insulin sensitivity. Specifically, SG improved NAFLD significantly by enhancing AMP-activated protein kinase (AMPK) phosphorylation and chaperone-mediated autophagy (CMA) that translate into the removal of Plin2 coating lipid droplets. This led to an increase in lipolysis and specific amelioration of hepatic insulin resistance. Elucidating the mechanism of impaired liver metabolism in obese subjects will help to design new strategies for the prevention and treatment of NAFLD.

Cost analysis and outcome of endoscopic submucosal dissection for colorectal lesions in an outpatient setting.

BACKGROUND AND STUDY AIMS: Endoscopic submucosal dissection (ESD), a minimally invasive treatment for early gastrointestinal (GI) cancer, is considered challenging and risky in the colorectum. As such, most patients undergoing ESD are hospitalized due to the perceived increased risk of adverse events. The aim of this study was to compare the costs, safety and efficacy of colorectal-ESD in an outpatient vs inpatient setting in a tertiary level center. METHODS: This is a retrospective study on consecutive patients admitted for colorectal-ESD. Patients were divided into outpatients (Group-A, same-day discharge), and inpatients (Group-B, admitted for at least one night). Data on overall costs, outcomes and adverse events were assessed for each group. RESULTS: A total of 136 patients were considered. Fourteen were excluded because ESD was not performed due to intraprocedural suspicion of invasive cancer. Eighty-three patients were treated as outpatients (Group-A, 68%) and 39 (Group-B, 32%) were hospitalized. R0-rate was 90.4% in Group-A and 89.7% in Group-B(P = 0.98). One perforation occurred in Group-A (1.2%) and 2 in Group-B(5.1%, P = 0.2). Mean Length of stay (LOS) was 1 day for outpatients and 3.3 days for inpatients. Management of Group-A as outpatients produced a cost savings of 941€ on average per patient. CONCLUSIONS: Outpatient colorectal-ESD is a feasible, cost-effective strategy to manage superficial colorectal tumors with outcomes comparable to inpatient colorectal-ESD. By using proper selection criteria, outpatient ESD could be considered the first-line approach for most patients.

Intragastric balloon or diet alone? A retrospective evaluation.

BACKGROUND: Very few studies have reported results of the BioEnterics Intragastric Balloon (BIB) at > or =12 months follow-up. The aim of this study is the retrospective evaluation of the results of BIB placement compared to diet regimen alone. METHODS: From January 2005 to June 2006, 130 outpatients underwent a structured diet plan with simple behavioral modification at our institutions. Controls (n = 130) were selected from the charts of patients who, during the same period, underwent BIB treatment. Patients in the outpatient group were given a structured balanced diet with a caloric intake between 1,000 and 1,200. The approximate macronutrient distribution, according the "Mediterranean diet," was 25% protein (at least 60 g/day), 20-25% lipids, and 50-55% carbohydrates. In the BIB group, patients received generic counseling for eating behavior. In both groups, we considered weight loss parameters (kilograms, percentage of excess weight loss [%EWL], body mass index [BMI], percentage of excess BMI loss [%EBL]) at 6 and 24 months from baseline and comorbidities at baseline and after 24 months. Results are expressed as mean+/-standard deviation. Statistical analysis was done by Student's t-test and chi (2)-test or Fisher's exact test. p < .05 was considered significant. RESULTS: At the time of BIB removal (6 months), significantly better results in terms of weight loss in kilograms (16.7 +/- 4.7 vs. 6.6 +/- 2.6; p < 0.01), BMI (35.4 +/- 11.2 vs. 38.9 +/- 12.1; p < 0.01), %EBL (38.5 +/- 16.1 Vs 18.6 +/- 14.3; p < 0.01), and %EWL (33.9 +/- 18 vs. 24.3 +/- 17.0; p < 0.01) were observed in patients treated by intragastric balloon as compared to diet-treated patients. At 24 months from baseline, patient dropout was 1/130 (0.7%) and 25/130 (19.2%) in the BIB and diet groups, respectively (p < 0.001). At this time, patients treated with intragastric balloon have tended to regain weight, whereas diet-treated patients have already regained most of lost weight. CONCLUSIONS: Although the strength of this study may be limited by its retrospective design, the results indicate that, in the short-to-medium term, BIB is significantly superior to diet in terms of weight loss.