Development and validation of a scoring system for pre-surgical and early post-surgical prediction of bariatric surgery unsuccess at 2 years.

Bariatric surgery (BS) is an effective treatment for morbid obesity. However, a simple and easy-to-use tool for the prediction of BS unsuccess is still lacking. Baseline and follow-up data from 300 consecutive patients who underwent BS were retrospectively collected. Supervised regression and machine-learning techniques were used for model development, in which BS unsuccess at 2 years was defined as a percentage of excess-weight-loss (%EWL) < 50%. Model performances were also assessed considering the percentage of total-weight-loss (%TWL) as the reference parameter. Two scoring systems (NAG-score and ENAG-score) were developed. NAG-score, comprising only pre-surgical data, was structured on a 4.5-point-scale (2 points for neck circumference ≥ 44 cm, 1.5 for age ≥ 50 years, and 1 for fasting glucose ≥ 118 mg/dL). ENAG-score, including also early post-operative data, was structured on a 7-point-scale (3 points for %EWL at 6 months ≤ 45%, 1.5 for neck circumference ≥ 44 cm, 1 for age ≥ 50 years, and 1.5 for fasting glucose ≥ 118 mg/dL). A 3-class-clustering was proposed for clinical application. In conclusion, our study proposed two scoring systems for pre-surgical and early post-surgical prediction of 2-year BS weight-loss, which may be useful to guide the pre-operative assessment, the appropriate balance of patients' expectations, and the post-operative care.

Robotic "Double Loop" Roux-en-Y gastric bypass reduces the risk of postoperative internal hernias: a prospective observational study.

BACKGROUND: Internal herniation (IH) is a potentially serious complication after laparoscopic Roux-en-Y gastric bypass (RYGB). The aim of the study is to evaluate the incidence of IH after robot-assisted RYGB (RA-RYGB) performed with the "Double Loop" technique at our Institution. METHODS: Prospective cohort study of patients submitted to RA-RYGB with the "Double Loop" technique, with a minimum follow-up of 2 years. Patients with complaints of abdominal pain at clinical visits or entering the emergency department were evaluated. Primary outcome was the incidence of IH, defined as the presence of herniated bowel through a mesenteric defect, diagnosed at imaging or at surgical exploration. RESULTS: A total of 129 patients were included: 65 (50.4%) were primary procedures, while 64 (49.6%) were revisional operations after primary restrictive bariatric surgery. Mean age was 47.9 ± 10.2 years, mean weight, and body mass index were, respectively, 105.3 ± 22.6 kg and 39.7 ± 9.6 kg/m2. Postoperative morbidity rate was 7.0%. Mean follow-up was 53.2 ± 22.6 (range 24-94) months. During the follow-up period, a total of 14 (10.8%) patients entered the emergency department: 1 patient had melena, 4 renal colic, 1 acute cholecystitis, 2 gynecologic pathologies, 2 anastomotic ulcers, 1 perforated gastric ulcer, 1 diverticulitis and 2 gastroenteritis. There were no diagnoses of IH. During the follow-up period, no patient experienced recurrence of symptoms. CONCLUSIONS: In the present study, the robotic approach confirms the low complication rate and absence of IH after "Double Loop" RA-RYGB in a large case-series at a medium-term follow-up.

Subclinical Left Ventricular Dysfunction in Severe Obesity and Reverse Cardiac Remodeling after Bariatric Surgery.

AIM: Obesity is associated with an increased cardiovascular risk. This study aimed to assess the role of echocardiography in the early detection of subclinical cardiac abnormalities in a cohort of obese patients with a preserved ejection fraction (EF) undergoing bariatric surgery. METHODS AND RESULTS: Forty consecutive severely obese patients (body mass index≥35 kg/m2) referring to our center for bariatric surgery were enrolled in this prospective cohort study. Despite a baseline EF of 61% ± 3%, almost half patients (43%) had a systolic dysfunction (SD) defined as global longitudinal strain (GLS)>-18%, and most of them (60%) had left ventricular hypertrophy (LVH) or concentric remodeling (CR). At 10-months after surgery, body weight decreased from 120 ± 15 kg to 83 ± 12 kg, body mass index from 44 ± 5 kg/m2 to 31 ± 5 kg/m2 (both P < 0.001). Septal and left ventricular posterior wall thickness decreased respectively from 10 ± 1 mm to 9 ± 1 mm (P = 0.004) and from 10 ± 1 mm to 9 ± 1 mm (P = 0.007). All systolic parameters improved: EF from 61% ± 3% to 64% ± 3% (P = 0.002) and GLS from -17% ± 2% to -20% ± 1% (P < 0.001). Epicardial fat thickness reduction (from 4.7 ± 1 mm to 3.5 ± 0.7 mm, P < 0.001) correlated with the reduction of left atrial area (P < 0.001 R = 0.35) and volume (P = 0.02 R = 0.25). Following bariatric surgery, we observed a reduced prevalence of LVH/CR (before 60%, after 22%, P = 0.001) and a complete resolution of preclinical SD (before 43%, after 0%, P < 0.001). Moreover, a postoperative reduction of at least 30 kg correlated with regression of septal hypertrophy (P < 0.001). CONCLUSIONS: Obese patients candidate to bariatric surgery have an high prevalence of preclinical SD and LVH/CR, early detectable with echocardiography. Bariatric surgery is associated with reverse cardiac remodeling; it might also have a preventive effect on atrial fibrillation occurrence by reducing its substrate.

Bariatric and metabolic surgery during COVID-19 outbreak phase 2 in Italy: why, when and how to restart.

In Italy elective bariatric and metabolic surgery was cancelled on February 21,2020 at the beginning of the so-called phase 1 of the SARS-CoV-2 outbreak. Gradually it was restarted on May 4,2020 at the beginning of the so-called phase 2, when epidemiological data showed containment of the infection. Before the outbreak in eight high-volume bariatric centers 840 patients were surgically treated developing a Covid-19 infection, during phase 1, in only 5 cases (0.6%) without mortality. The post-operative complication rate was similar when compared to the 836 subjects submitted to bariatric surgery the year before. Since the high prevalence of infection in subjects with BMI > 30, it was argued that early intervention on obesity during phase 2 could help to minimize the effects of the disease in the event of a possible reversion to a SARS-CoV-2 outbreak phase 1. At the same time a prospective observational study from July 1 till the WHO declaration of the end of the pandemic has started in the eight high volume centers to monitor the post-operative outcome and its effect on SARS-CoV-2 infection.

Robotic Roux-en-Y Gastric Bypass as a Revisional Bariatric Procedure: a Single-Center Prospective Cohort Study.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is the procedure of choice to manage the failure of primary bariatric surgery. However, the current evidence on the role of the robotic technology in revisional bariatric surgery is very limited. The aim of this study is to report safety and effectiveness of revisional RYGB performed with the DaVinci Robotic Surgical System (R-rRYGB) after failed primary bariatric surgery. METHODS: Clinical data of consecutive patients undergoing R-rRYGB were included in a prospectively collected database. Intraoperative findings, early postoperative outcomes, and 1-year follow-up results were considered. Primary outcome was postoperative morbidity rate. Secondary outcomes were conversion to open surgery, length of stay, percentage of excess weight loss (%EWL), resolution of complications, and costs. RESULTS: A total of 68 patients underwent R-rRYGB at our department from 2011 to 2016. Primary procedures were laparoscopic adjustable gastric banding (n = 10), vertical banded gastroplasty (n = 43), and sleeve gastrectomy (n = 15). Conversion rate to open surgery was 2.9%. Postoperative morbidity rate was 8.8%, with no anastomotic leaks reported. Total cost for surgical procedure was 14,334.7 ± 2920.4 €. CONCLUSIONS: Revisional RYGB is a complex procedure but can be performed with the robotic approach with a low morbidity rate. Weight loss outcomes and resolution of complications of the index procedure are satisfactory.

Destiny of Failed Adjustable Gastric Bandings: Do All the Patients Need Further Bariatric Surgery?

PURPOSE: The number of laparoscopic adjustable gastric banding (LAGB) removal has increased throughout the years. The aim of the study was to evaluate the outcomes in patients undergoing LAGB removal with or without further bariatric surgery. MATERIALS AND METHODS: Data prospectively collected from consecutive patients undergoing LAGB removal from 2008 to 2016 at our institution were retrospectively analyzed. Obesity-related comorbidities, complications, and body mass index (BMI) before removal and at 1-year follow-up were evaluated. RESULTS: A total of 156 patients were included in the study. Seventy-six patients had further surgery (SURG group): 55 underwent laparoscopic sleeve gastrectomy (LSG) and 21 laparoscopic Roux-en-Y gastric bypass (LRYGB). Eighty patients underwent only LAGB removal (No-SURG group). The mean BMI was lower in the No-SURG group (33.9 vs 36.3 kg/m2, p = 0.0055). Reasons for removal were different in the two groups: dysphagia, frequent vomiting, and LAGB-related complications requiring urgent treatment occurred more commonly in the No-SURG group (p < 0.05): 71.3 vs 51.3%, 67.5% vs. 38.2%, 28.8% vs. 6.6%, respectively. At 1-year follow-up, 96.3% of No-SURG patients regained weight after LAGB removal; two (2.5%) patients showed new-onset comorbidities, four (5%) needed adjustments in pharmacological therapy, and four (5%) complained from persistence of GERD symptoms. Additional surgery provided significant weight loss: the mean %TWL was 23.7% after LSGs and 27.2% after LRYGBs. CONCLUSIONS: LAGB is associated with a high rate of reoperation. Further bariatric surgery after LAGB removal should be considered due to weight regain, persistence of GERD symptoms, and new-onset comorbidities.

National survey for bariatric procedures in adolescents: Long time follow-up.

INTRODUCTION: The role of bariatric surgery and its role in adolescent is still under discussion worldwide. The aim of this study is to report an Italian survey for bariatric procedures in adolescents and the outcome with a medium and long-term follow-up. MATERIALS AND METHODS: We retrospectively analyzed consecutive data added into the Italian register of the society for bariatric surgery(period 2000-2010). We evaluated all patients treated in a 10-year period with a mean follow-up of 3 years. Inclusion and exclusion criteria were created. All patients were aged between 13 and 18 years. We evaluated and compared clinical data. RESULTS: After reviewing medical charts, 173 patients were considered for the study; 85 patients were treated with adjustable gastric band (AGB), 47 with intragastric balloon (IB), 26 with sleeve gastrectomy (SG) and other 15 patients with malabsorptive techniques (MT). Among clinical data, there was a statistical difference in terms of %excess weight loss (%EWL) between techniques only after 1 year post-procedure; at 5 years, considering the percentage of patients studied, sleeve gastrectomy had the best %EWL respect to other non malabsorptive techniques (p<0.05); at 5 year more than 90% resolved their comorbidities especially hypertension, dyspnea, orthopedic problems and dyspnea. CONCLUSIONS: This study is the first reporting a national survey in adolescent; more than 80% of patients are followed until 5 years post-op but only few patients (less than 5%) until 10 years. Our results demonstrated that sleeve gastrectomy in adolescent is safe and had a better %EWL respect to other non-malabsorptive bariatric procedures. LEVEL OF EVIDENCE: level III.

Increased Esophageal Exposure to Weakly Acidic Reflux 5 Years After Laparoscopic Roux-en-Y Gastric Bypass.

OBJECTIVE: To evaluate the long-term effects of laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on gastroesophageal function. BACKGROUND: LRYGB is considered the weight loss procedure of choice for obese patients with gastroesophageal reflux disease (GERD). However, long-term instrumental evaluations of GERD after LRYGB are not available. METHODS: Morbidly obese patients selected for LRYGB were included in a prospective study. We performed clinical evaluation with GERD-HRQoL questionnaire, upper endoscopy, esophageal manometry, and 24-hour impedance pH (24-hour MII-pH) monitoring preoperatively and at 12 and 60 months after surgery. This trial is registered with ClinicalTrials.gov (no. NCT02618044). RESULTS: From May 2006 to May 2009, 86 patients entered the study and 72 (84%) completed the 5-year protocol. At preoperative 24-hour MII-pH monitoring, 54 patients (group A) had normal values, whereas 32 (group B) had diagnosis of GERD: 23 had acidic reflux, whereas 9 had combined reflux [acidic + weakly acidic reflux (WAR)]. The groups were similar in preoperative age, body mass index, and comorbidities. At 12 and 60 months, significant improvement in questionnaire scores was observed in group B patients. No manometric changes occurred in both groups; 24-hour MII-pH monitoring showed a significant reduction in acid exposure, but an increase of WAR in both group A (from 0% to 52% to 74%) and group B (from 35% to 42% to 77%). At long-term follow-up, esophagitis was found in 14 group A (30%) and in 18 group B patients (69%) (P < 0.001). CONCLUSIONS: LRYGB allows to obtain an effective GERD symptom amelioration and a reduction in acid exposure. However, 3 out 4 patients present with distal esophagus exposure to WAR.

What is the impact of sleeve gastrectomy and gastric bypass on metabolic control of diabetes? A clinic-based cohort of Mediterranean diabetic patients.

BACKGROUND: Effectiveness of sleeve gastrectomy and gastric bypass on glycemic, blood pressure, and lipids control in obese type 2 diabetic patients is poorly known. OBJECTIVE: To assess the effectiveness of bariatric surgery on obese patients with type 2 diabetes. SETTING: University hospital, Italy. METHODS: Diabetes remission and metabolic changes over postoperative follow-up were assessed in 135 obese patients with type 2 diabetes who underwent bariatric surgery in 2007-2011 (gastric bypass, n = 100; sleeve gastrectomy, n = 35). Repeated-measures analysis of variance and logistic regression were used. RESULTS: Diabetes remission was observed in 22% and 21.5% of the patients, respectively, 1 and 2 years after surgery. Compared with the remaining patients, patients in diabetes remission were significantly younger, had lower diabetes duration, hemoglobin A1c (HbA1c), fasting plasma glucose, and frequency of insulin treatment. Trends of HbA1c, body mass index (BMI), blood pressure, and plasma triglycerides revealed a significant decrease over time and the trend of HDL-cholesterol revealed a significant increase over time in both treatment groups (P<.001). Patients reaching target levels for at least 3 out of 5 indicators of intermediate outcomes of care (composite indicator of good diabetes control) were 25.5% at the baseline and 66.1% at final follow-up visit (P<.001). In logistic regression, age (OR = .89, 95% CI .84-.95), HbA1c (OR = .67, 95% CI .49-0.91) and diabetes duration (OR = .87, 95% CI .77-1.00) were independent predictors of diabetes remission. CONCLUSIONS: Bariatric surgery is an effective approach to optimize glucose, lipids, and blood pressure control in obese type 2 diabetic patients. Bariatric surgery should be offered earlier over the natural course of diabetes to increase the likelihood of diabetes remission in obese patients.

Gastric Cancer After Restrictive Bariatric Surgery: A Clinical Pitfall.

Although vertical banded gastroplasty is rarely performed at present, most bariatric surgery departments continue to follow up patients who underwent this procedure in the past few decades. In view of this, it is advisable for bariatric and general surgeons to know how to diagnose the very rare event of the development of a gastric cancer after this restrictive procedure. In this report, 2 cases of gastric cancer occurring years after vertical banded gastroplasty are presented, and clinical presentation and diagnostic difficulties are discussed.

Esophagogastric cancer after bariatric surgery: systematic review of the literature.

BACKGROUND: Because the number of patients with a previous bariatric procedure continues to rise, it is advisable for bariatric surgeons to know how to manage the rare event of the development of an esophagogastric cancer. The aim of the study was to perform a systematic review of all reported cases of esophagogastric cancers after bariatric surgery. METHODS: Systematic review of English and French written literature in MEDLINE and EMBASE database. RESULTS: Globally, 28 articles describing 33 patients were retrieved. Neoplasms were diagnosed at a mean of 8.5 years after bariatric surgery (range 2 months-29 years). There were 11 esophageal and 22 gastric cancers; although adenocarcinoma represented most cases (90.6%), a tubulovillous adenoma with high-grade atypia, an intramural gastrointestinal stromal tumor, and a diffuse large B-cell lymphoma of the gastric fundus were also reported. Node involvement was reported in 14 cases, and distal metastases in 5. The most frequently reported symptoms were dysphagia and food intolerance, vomiting, epigastric pain, and weight loss. Surgery was performed in 28 patients, although 4 underwent only chemotherapy and/or radiotherapy and 1 received palliative care. Reported mortality rate was 48.1%. CONCLUSIONS: To date, it is not possible to quantify the incidence of esophagogastric cancer after bariatric surgery because of the paucity of reported data. Nevertheless, because the main concern is the delay in diagnosis, it is of critical importance to carefully evaluate any new or modified upper digestive tract symptom occurring during bariatric surgery follow-up.

Age as a long-term prognostic factor in bariatric surgery.

OBJECTIVE: : To analyze the potential effects of preoperative age on postoperative weight loss in patients who underwent Roux-en-Y gastric bypass (RYGBP) with long-term follow-up data. BACKGROUND: : The reasons for individual differences in surgically induced weight loss are not completely understood. To date, there are no available studies specifically aimed at analyzing the effects of age on weight loss in patients undergoing the same operation and with long-term follow-up data. METHODS: : Retrospective analysis of prospectively collected data for all patients who underwent RYGBP between 2006 and 2010. To evaluate weight loss, we used preoperative and follow-up body mass index (BMI), analyzed by the mixed-effects linear model for repeated measures. To evaluate age effects, patients were classified in quartiles (≤35 years, 36-42 years, 43-51 years, ≥52 years). RESULTS: : A total of 489 patients entered the study; preoperatively, the younger group showed a significantly higher BMI (mean BMI: 48.2 in patients aged ≤35 years, 46.9 in 36-42 years, 45.5 in 43-51 years, 45.7 in ≥52 years, P = 0.014) and a higher percentage of super-obesity (41.6% among patients aged ≤35 years, 28.1% among 36-42 years, 27.6% among 43-51 years, 28.3% among ≥ 52 years, P = 0.047). In spite of this, younger patients experienced a significantly greater and prolonged BMI decrease during the entire follow-up period and the BMI trend over time resulted significantly modified according to age quartiles (P = 0.036). CONCLUSIONS: : This study provides a new prognostic factor in bariatric surgery: patient age. Because advanced age represents a risk factor for complications and mortality, and given that bariatric surgery may not be as effective in older patients compared to younger subjects, we believe that surgical indications in patients older than 50 years should be carefully weighed up.

High glucose via NOX-dependent ROS generation and AKT activity promotes adipose-derived stem cell de-differentiation.

NADPH-oxidase (NOX)-dependent reactive oxygen species (ROS) production is involved in self-renewal of stem and progenitor cells. Herein, we investigated whether high glucose (25 mM/L) (HG)-dependent NOX-mediated ROS generation is involved in self-renewal of visceral adipose tissue-derived stem cells (ASCs) as well. To this end ASCs cultured in HG or normal glucose (5 mM/L) used as control, were evaluated for their stem cell identity. We demonstrated that freshly isolated ASCs are pluripotent as they differentiate into adipocytes in-vitro and form neovessels in-vivo. However, only HG-cultured ASCs expressed octamer-binding transcription factor 4 (Oct4) and Nanog and formed spheroids. The assembly of p47phox and p67phox subunits is crucial for NOX-enzymatic activity. By knock-down of p47phox the role of NOX-generated ROS in driving ASC de-differentiation has been provided. siRNA technology was also applied to demonstrate the role of Akt activity in mediating HG-induced Oct-4 and Nanog expression as well as spheroid formation. Additionally, by knock-down of Oct4 we provided further evidence that Oct4 is essential for HG-mediated stem cell identity. Soluble factors released by ASCs are key elements in their mechanism of action. We found that NOX and Akt activity are required for cytokine production by "spheroids". Finally, as HG-cultured ASCs, diabetic patient-derived ASCs expressed higher levels of Oct-4 and Nanog than ASCs derived from healthy subjects and engaged ROS and Akt activity to turn on their secretion program. Thereby, our data indicate that HG via NOX-dependent Akt activity induces ASC de-differentiation, and suggest that HG pre-conditioning might be exploited for ASC ex-vivo expansion.

10-year follow-up of laparoscopic vertical banded gastroplasty: good results in selected patients.

OBJECTIVE: To evaluate the long-term results of laparoscopic vertical banded gastroplasty (VBG) for morbid obesity. BACKGROUND: Laparoscopic VBG, a safe and straightforward bariatric procedure characterized by good short-term results, has been progressively replaced by other more complex procedures on the basis of a presumed high rate of long-term failure. Nevertheless, some authors have recently reported long-term efficacy in selected patients. METHODS: All patients who underwent laparoscopic VBG were included in a prospective database. Patients reaching 10-year follow-up received a complete evaluation including clinical, endoscopic, and biochemical examinations. RESULTS: Between January 1996 and March 1999, 266 morbidly obese patients underwent bariatric procedures. Among them, 213 were selected for laparoscopic VBG; exclusion criteria were as follows: contraindications to pneumoperitoneum, gastroesophageal reflux disease, and psychological contraindications to restrictive procedures. Mean age, preoperative weight, and body mass index were 36.9 years, 123.6 kg, and 45.4 kg/m, respectively. Intraoperative complication rate and conversion rate were 0.9% and 0.9%, respectively. Early postoperative complication rate was 4.2% and early reoperation rate was 0.5%. Mean hospital length of stay was 6.3 days. Mortality was nil. The 10-year follow-up rate was 70.4% (150 patients). Late postoperative complication rate was 14.7%, and 10-year revisional surgery rate was 10.0%. The excess weight loss percentages at 3, 5, and 10 years were 65.0%, 59.9%, and 59.8%, respectively. The resolution and/or improvement rate for comorbidity were 47.5% for hypertension, 55.6% for diabetes, 75% for sleep apnea, and 47.4% for arthritis. Mean Moorehead-Ardelt Quality of Life Questionnaire and BAROS values were 1.4 and 3.8, respectively. CONCLUSIONS: The present study demonstrates that laparoscopic VBG in carefully selected patients leads to long-term results comparable with more complex and invasive procedures. Given the low postoperative morbidity for laparoscopic VBG, its present clinical role should be, in our opinion, reevaluated.

Laparoscopic adjustable silicone gastric banding vs laparoscopic vertical banded gastroplasty in morbidly obese patients: long-term results of a prospective randomized controlled clinical trial.

BACKGROUND: Aim of the study is to present long-term results of a prospective randomized single-institution clinical trial comparing laparoscopic adjustable silicone gastric banding (LASGB) with laparoscopic vertical banded gastroplasty (LVBG) in morbid obesity. METHODS: A total of 100 morbidly obese patients (body mass index 40 to 50 kg/m2) were randomized to LASGB (n=49) or LVBG (n=51) and followed up for a minimum of 7 years. RESULTS: Mean operative time was 65.4 min in LASGBs and 94.2 min in LVBGs (p<0.05); mean hospital stay was 3.7 and 6.6 days, respectively (p<0.05). Late complication rates were 36.7% in LASGBs vs 15.7% in LVBGs at 3 years (p<0.05), 46.9% vs 43.1% at 5 years (NS), and 55.1% vs 47.1% at 7 years (NS). Late reoperation rates were 28.6% in LASGBs and 2.0% in LVBGs at 3 years (p<0.001), 38.8% and 2.0% at 5 years (p<0.001), and 46.9% and 7.8% at 7 years (p<0.001). Excess weight loss in LASGBs was 41.8% at 3 years, 33.2% at 5 years, and 29.9% at 7 years; excess weight loss in LVBGs was 60.9%, 57%, and 53.1%, respectively (p<0.05). CONCLUSIONS: This study demonstrates that in a carefully selected group of patients, LVBG is significantly more effective than LASGB in terms of late complications, late reoperations, and long-term results on weight loss.

Disappointing results with a 5 cm calibrating device for laparoscopic vertical banded gastroplasty.

BACKGROUND: The gastric outlet represents a critical point of laparoscopic vertical banded gastroplasty (LVBG): the diameter and the material used to calibrate the gastric outlet are essential for long-term success. We present the results of our initial clinical experience with the Proring band, a new calibrating device specifically designed to calibrate LVBG outlet. METHODS: Between February and April 2004, 13 LVBG were performed using the Proring band. There were 12 women and one man; their mean age was 44 years; mean preoperative weight was 118.8 kg; mean body mass index (BMI) was 44.4 kg/m(2). RESULTS: The immediate postoperative course was uneventful in all cases. In the follow-up 10 patients out of 13 (76.9%) presented a sudden or progressive food intolerance. Five patients were immediately reoperated by laparoscopic approach and five underwent endoscopic dilatation with initial clinical improvement; early recurrence of symptoms despite further dilatations occurred in four out of five cases. These four patients were then reoperated. Therefore a total of nine (69.2%) patients underwent a laparoscopic reoperation with Proring band removal and its replacement with a polypropylene band. In seven cases an intraoperative endoscopic dilatation was associated with the laparoscopic procedure. Outcome was successful in all cases, with discharge after two days. CONCLUSION: The results of our experience using the Proring band are unsatisfactory, showing 76.9% with outlet stenosis and 69.2% with reoperations. These data compare negatively with our previous experience on more than 900 VBG procedures using polypropylene mesh.

Mortality after bariatric surgery: analysis of 13,871 morbidly obese patients from a national registry.

OBJECTIVE: To define mortality rates and risk factors of different bariatric procedures and to identify strategies to reduce the surgical risk in patients undergoing bariatric surgery. SUMMARY BACKGROUND DATA: Postoperative mortality is a rare event after bariatric surgery. Therefore, comprehensive data on mortality are lacking in the literature. METHODS: A retrospective analysis of a large prospective database was carried out. The Italian Society of Obesity Surgery runs a National Registry on bariatric surgery where all procedures performed by members of the Society should be included prospectively. This Registry represents at present the largest database on bariatric surgery worldwide. RESULTS: Between January 1996 and January 2006, 13,871 bariatric surgical procedures were included: 6122 adjustable silicone gastric bandings (ASGB), 4215 vertical banded gastroplasties (VBG), 1106 gastric bypasses, 1988 biliopancreatic diversions (BPD), 303 biliointestinal bypasses, and 137 various procedures. Sixty day mortality was 0.25%. The type of surgical procedure significantly influenced (P < 0.001) mortality risk: 0.1% ASGB, 0.15% VBG, 0.54% gastric bypasses, 0.8% BPD. Pulmonary embolism represented the most common cause of death (38.2%) and was significantly higher in the BPD group (0.4% vs. 0.07% VBG and 0.03% ASGB). Other causes of mortality were the following: cardiac failure 17.6%, intestinal leak 17.6%, respiratory failure 11.8%, and 1 case each of acute pancreatitis, cerebral ischemia, bleeding gastric ulcer, intestinal ischemia, and internal hernia. Therefore, 29.4% of patients died as a result of a direct technical complication of the procedure. Additional significant risk factors included open surgery (P < 0.001), prolonged operative time (P < 0.05), preoperative hypertension (P < 0.01) or diabetes (P < 0.05), and case load per Center (P < 0.01). CONCLUSIONS: Mortality after bariatric surgery is a rare event. It is influenced by different risk factors including type of surgery, open surgery, prolonged operative time, comorbidities, and volume of activity. In defining the best bariatric procedure for each patient the different mortality risks should be taken into account. Choice of the procedure, prevention, early diagnosis, and therapy for cardiovascular complications may reduce postoperative mortality.

Psychological predictors of outcome in vertical banded gastroplasty: a 6 months prospective pilot study.

BACKGROUND: At present, bariatric surgery is the most effective treatment for morbid obesity. Several factors appear to influence the patient's ability to adjust to the postoperative condition, but reliable predictors are lacking. The aim of this study was to assess whether psychological presurgical variables can predict outcome of vertical banded gastroplasty (VBG) in the short term. METHODS: 38 severely obese patients (6 men and 32 women) underwent laparoscopic VBG. All were assessed prospectively at TO (before surgery) and at T6 (6 months after surgery) with a semi-structured interview and a battery of psychological tests: State Trait Anger Expression Inventory (STAXI), Eating Disorder Inventory (EDI-2), Symptom Checklist 90 (SCL-90), Beck Depression Inventory (BDI), Binge Eating Scale (BES), Body Shape Questionnaire (BSQ), and (only at TO) the Temperament and Character Inventory (TCI). RESULTS: The comparison between TO and T6 found a significant weight loss and an improvement in several dimensions of EDI-2, BDI, and BSQ, together with an increase in the frequency of vomiting. Self-directedness (TCI) and Body Dissatisfaction (EDI-2) appear to be predictors of short-term outcome regarding weight loss. Self-transcendence (TCI) is associated with emerging side-effects. CONCLUSION: Although larger and longer studies are necessary to confirm these data, Self directedness and Self trascendence emerge as predictors of 6 months clinical and psychological outcome of VBG.

Progress in implantable gastric stimulation: summary of results of the European multi-center study.

BACKGROUND: The Implantable Gastric Stimulator (IGS(R)), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss. The LOSS (Laparoscopic Obesity Stimulation Survey) is a prospective non-randomized trial which enrolled 69 patients involving 11 investigator centers in 5 European Countries. In 19 patients, ghrelin was analyzed. METHODS: Between January 2002 and December 2003, 69 patients (F/M 49/20), mean age 41 years (18-65) underwent IGS implantation. Mean BMI was 41 (35-57), mean weight 115.0 kg (65-160) and mean excess weight (EW) 52 kg (13-89). The IGS was actived 30 days after implantation. In a subset of 19 patients studied further, 0, 6, and 12 months appetite and satiety score were evaluated and 0 and 6 months ghrelin profile was analyzed. RESULTS: The mean +/- standard error %EWL was: 8.6+/-1.8 at 1 month, 15.8+/-2.3 at 3 months, 17.8+/-2.6 at 6 months, 21.0+/-3.5 at 10 months, and 21.0+/-5.0 at 15 months. There were no intraoperative surgical or long-term complications. 7 intra-operative gastric penetrations occurred, observed by gastroscopy, without sequelae. 1 patient required a reoperation to remove a retained lead needle. In the subset of 19 patients, appetite was reduced and post-prandial and inter-prandial satiety was increased after IGS implantation. In the 19 patients, despite weight reduction, ghrelin did not increase. CONCLUSION: IGS can be implanted laparoscopically with minimal perioperative complications. Appetite is reduced and satiety is increased after the implantation. Ghrelin levels could be one of the mechanisms explaining weight loss and weight maintenance in IGS patients. If weight loss is maintained, IGS could be considered a good option for selected patients.

Laparoscopic adjustable silicone gastric banding versus vertical banded gastroplasty in morbidly obese patients: a prospective randomized controlled clinical trial.

OBJECTIVE: To compare, in a prospective, randomized, single-institution trial laparoscopic adjustable silicone gastric banding (LASGB) with laparoscopic vertical banded gastroplasty (LVBG) in morbidly obese patients. SUMMARY BACKGROUND DATA: LASGB is a simple and safe procedure, but some reports have suggested disappointing long-term results. Despite the recent widespread use of LASGB, there are no prospective nor randomized trials comparing LASGB with other laparoscopic procedures. METHODS: A total of 100 morbidly obese patients, with body mass index (BMI) 40 to 50 kg/m2, without compulsive eating, were randomized to either LASGB (n = 49) or LVBG (n = 51). Minimum follow-up was 2 years (mean 33.1 months). RESULTS: There were no deaths or conversions in either group. Mean operative time was 94.2 minutes in LVBGs and 65.4 in LASGBs (P < 0.05). Early morbidity rate was lower in LASGBs (6.1%) versus LVBGs (9.8%) (P = 0.754). Mean hospital stay was shorter in LASGBs versus LVBGs: 3.7 days versus 6.6 (P < 0.05). Late complications rate in LVBGs was 14% (7 of 50) and in LASGBs 32.7% (16 of 49) (P < 0.05). The most frequent complication was the slippage of the band (18%). Late reoperations rate in LVBGs was 0% (0 of 50) versus 24.5% (12 of 49) in LASGBs (P < 0.001). Excess weight loss in LVBGs was, at 2 years, 63.5% and, at 3 years, 58.9%; in LASGBs, excess weight loss, respectively, was 41.4% and 39%. BMI in LVBGs was, at 2 years, 29.7 kg/m2 and, at 3 years, 30.7 kg/m2; in LASGBs, BMI was 34.8 kg/m2 at 2 years and 35.7 kg/m2 at 3 years. According to Reinhold's classification, a residual excess weight <50% was achieved, at 2 years, in 74% of LVBG and 35% of LASGB (P < 0.001). CONCLUSIONS: This study demonstrates that, in patients with BMI 40 to 50 kg/m2, LASGB requires shorter operative time and hospital stay but LVBG is more effective in terms of late complications, reoperations, and weight loss.