Global 30-Day Morbidity and Mortality of Primary Bariatric Surgery Combined with Another Procedure: The BLEND Study.

BACKGROUND: No robust data are available on the safety of primary bariatric and metabolic surgery (BMS) alone compared to primary BMS combined with other procedures. OBJECTIVES: The objective of this study is to collect a 30-day mortality and morbidity of primary BMS combined with cholecystectomy, ventral hernia repair, or hiatal hernia repair. SETTING: This is as an international, multicenter, prospective, and observational audit of patients undergoing primary BMS combined with one or more additional procedures. METHODS: The audit took place from January 1 to June 30, 2022. A descriptive analysis was conducted. A propensity score matching analysis compared the BLEND study patients with those from the GENEVA cohort to obtain objective evaluation between combined procedures and primary BMS alone. RESULTS: A total of 75 centers submitted data on 1036 patients. Sleeve gastrectomy was the most commonly primary BMS (N = 653, 63%), and hiatal hernia repair was the most commonly concomitant procedure (N = 447, 43.1%). RYGB accounted for the highest percentage (20.6%) of a 30-day morbidity, followed by SG (10.5%). More than one combined procedures had the highest morbidities among all combinations (17.1%). Out of overall 134 complications, 129 (96.2%) were Clavien-Dindo I-III, and 4 were CD V. Patients who underwent a primary bariatric surgery combined with another procedure had a pronounced increase in a 30-day complication rate compared with patients who underwent only BMS (12.7% vs. 7.1%). CONCLUSION: Combining BMS with another procedure increases the risk of complications, but most are minor and require no further treatment. Combined procedures with primary BMS is a viable option to consider in selected patients following multi-disciplinary discussion.

Trends and safety of bariatric revisional surgery in Italy: multicenter, prospective, observational study.

BACKGROUND: Revisional bariatric surgery (RBS) represents a further solution for patients who experience inadequate weight loss (IWL) following primary bariatric surgery (BS) or significant weight regain (WR) following initial satisfactory response. RBS guidelines are lacking; however, an increased trend in further BS offerings has been reported recently. OBJECTIVE: Analyze trend, mortality, complication, readmission, and reoperation rates for any reason at 30 days after RBS in Italy. SETTING: Ten Italian high-volume BS centers (university hospitals and private centers). METHODS: Prospective, observational, multicenter study enrolling patients undergoing RBS between October 1, 2021, and March 31, 2022, registering reasons for RBS, technique, mortality, intraoperative and perioperative complications, readmissions, and reinterventions for any reason. Patients undergoing RBS during the same calendar interval in 2016-2020 were considered control patients. RESULTS: A total of 220 patients were enrolled and compared with 560 control-group patients. Mortality was .45% versus .35% (n.s), with an overall mortality of .25%, while open surgery or conversion to open surgery was registered in 1%. No difference was found for mortality, morbidity, complications, readmission (1.3%), and reoperation rates (2.2%). IWL/WR was the most frequent cause, followed by gastroesophageal reflux disease; Roux-en-Y gastric bypass was the most used revisional procedure (56%). Sleeve gastrectomy was the most revised procedure in the study group, while gastric banding was the most revised in the control group. RBS represents up to 9% of the total BS in the Italian participating centers. CONCLUSIONS: Laparoscopy represents the standard approach for RBS, which appears safe. Current Italian trends show a shift toward sleeve gastrectomy being the most revised procedure and Roux-en-Y gastric bypass being the most frequent revisional procedure.

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.

Value-Based Healthcare and Enhanced Recovery After Surgery Implementation in a High-Volume Bariatric Center in Italy.

BACKGROUND: Bariatric surgery is the most effective treatment for patients affected by morbid obesity. The Enhanced Recovery After Surgery (ERAS) protocol increases clinical outcomes, but the most recent literature shows incomplete patients' adherence. This study aims to demonstrate the feasibility of applying a Value-Based Healthcare (VBHC) strategy associated with ERAS to increase patients' engagement and outcomes. METHOD: A multiprofessional team redesigned the process considering ERAS recommendations and patients' feedbacks. Outcomes that matter to patients were defined with structured patients' interviews and collected in the electronic clinical record. Adherence to the pathway and the cost of the cycle of care were measured to demonstrate sustainability. A model was developed to grant its replicability. RESULTS: A total of 2.122 patients were included. The lowest adherence to the protocol for a single item was 82%. 74% of excess weight loss; 90% better comorbidities control; 77.5% had no pain after surgery; 61% no postoperative nausea and vomiting. Zero mortality; 1.8% overall morbidity; 0.4% readmission and reoperation rate within 30 days. The average length of stay is 2.1 days. Patient-Reported Outcome Measures (PROMs) documented increased productivity and quality of life. CONCLUSION: Building a caring relationship by a multidisciplinary team, adding patient wellness in a VBHC framework on top of ERAS as a patient-centered approach, increases patients' engagement and adherence to the pathway of care, resulting in better health outcomes (clinical and PROMs). The Value-Based Model is sustainable and replicable; it represents the prototype for redesigning other pathways and may become a model for other organizations.

Sleeve gastrectomy leads to easy management of hormone replacement therapy and good weight loss in patients treated for craniopharyngioma.

The aim of this study is to investigate the effects of sleeve gastrectomy on hormone replacement therapy and on hypothalamic obesity in patients affected by craniopharyngioma with post-surgical pan-hypopituitarism. A retrospective review of three patients, treated for hypothalamic obesity with laparoscopic sleeve gastrectomy, who have previously undergone surgery for craniopharyngioma in their childhood, was done. Patients' mean age and BMI were 22.3 years (range 21-24) and 49.2 kg/m2 (range 41.6-58.1), respectively. The mean time of delay between neurosurgery and bariatric surgery was 12.3 years (range 6-16). There were no major complications or deaths. At 24 months follow-up, the mean BMI was 35.3 kg/m2 (range 31.2-40.6). No hydrocortisone and sex steroids dose changes were observed, while levothyroxine was decreased in two patients. Growth hormone replacement therapy was increased in two patients, whereas it was started in one patient. Desmopressin was significantly decreased in all of them. Patients with surgically induced pan-hypopituitarism after craniopharyngioma who become obese, can expect good results from sleeve gastrectomy: this procedure does not have significant negative effects on hormone substitution and leads to a good stabilization of body weight in a mid-term follow-up.

Dietary habits and body weight at long-term following biliopancreatic diversion.

AIM: This study aims to evaluate the role of simple carbohydrates and alcohol intake in determining weight of stabilization at long-term following malabsorptive bariatric surgery. MATERIAL AND METHODS: Sixty patients at more than 2 years following biliopancreatic diversion (BPD) were submitted to an alimentary interview for evaluating the daily consumption of simple sugar, fruits, ice-cream, sweets, and caloric and alcoholic beverages. Eating behavior was assessed by Three Factors Eating Questionnaire. RESULTS: The mean estimated daily energy consumption intake was 2,852 kcal, with a mean daily intake of simple carbohydrates of 89 g that represented 12% of the total energy intake. The current body weight was positively and independently related to the preoperative body weight and to simple carbohydrate and alcohol intake and negatively related to physical activity, while no association with total energy consumption and eating behavior was found. DISCUSSION: These findings confirm that following BPD the body weight is independent of energy intake and eating behavior. Furthermore, these data suggest that in post-BPD subjects the simple carbohydrates and alcohol absorption is fully preserved, and that the operated subjects could regulate their body weight by reducing simple carbohydrates and alcoholic intake and increasing physical activity.

Histological alterations following bariatric surgery: pilot study.

BACKGROUND: Macroscopic clinical evidence of tissue damaging following bariatric surgery pushed plastic surgeons to presume microscopic alterations as well. METHODS: Five preliminary cases studied randomly, and compared with healthy tissues, confirmed these initial suspects. A deeper and wider study has then been structured. RESULTS: Preliminary results are so evident to encourage us to carry on an estimated 2-3 years multidisciplinary study. CONCLUSIONS: What we want to study is if histological post-bariatric alterations are confirmed, and if these can be considered responsible for higher complication rate in body contouring following bariatric surgery.

Behavioral characteristics of severely obese patients seeking bariatric surgery: cross-sectional study with alimentary interview.

The authors' aim in this study was to gain insight on the eating behaviors of severely obese patients seeking bariatric surgery. The authors compared anthropometric and alimentary interview data on 50 patients applying for biliopancreatic diversion with data obtained from 50 severely obese individuals enrolling in a behavior modification weight-loss program. The severely obese patients seeking bariatric surgery were metabolically more compromised than were their counterparts enrolled in the conservative treatment group, whereas the latter more often reported compromised eating behaviors. These unexpected results could reflect changes in the widespread attitudes toward bariatric surgery-that unlike in the past, it is now considered a safe and effective method to treat a serious disease.

Does biliopancreatic diversion carry increased risk for colorectal cancer? A cohort study.

BACKGROUND: Because of the rearrangement of the gastrointestinal tract, biliopancreatic diversion (BPD) could lead to an increased risk of colorectal cancer caused by possible carcinogenetic action of the unabsorbed food and bile acid on colonic mucosa. METHODS: The incidence of colorectal cancer in 1,898 obese subjects submitted to BPD from May 76 to July 2002 with a minimum follow-up of 5 years was retrospectively evaluated. RESULTS: Among 28,811 person-years, seven cases of colorectal cancer were detected, for an overall incidence of 29.4 per 100,000, which is not different from that observed in the general Italian population, and lower than that reported for obese and type 2 diabetes patients. Logistic regression model suggests that occurrence of colorectal cancer is positively related to the time elapsed from BPD. CONCLUSION: This study indicates that BPD does not carry any increased risk for colorectal cancer. The complete postoperative restoration of insulin sensibility could exert a valuable protective action.

Bariatric surgery in adolescents: a long-term follow-up study.

BACKGROUND: The benefits of bariatric surgery in adult obese patients are well known, but data are lacking regarding the outcome of the surgery in adolescents. The aim of this study was to retrospectively assess the operative morbidity and mortality, percentage of loss of initial excess weight, and the incidence of long-term complications and reoperations in a cohort of obese patients who underwent biliopancreatic diversion (BPD) before their 18th birthday. METHODS: A total of 76 adolescent subjects underwent BPD between 1976 and 2005. Of these 78 patients, 7 had Prader-Willi syndrome and 1 had Turner syndrome and were excluded from the study. RESULTS: The patient population comprised 52 girls and 16 boys. Their mean age was 16.8 years, mean body weight at operation was 125 kg (mean body mass index 46 kg/m2). Operative mortality was nil. The mean follow-up was 11 years (range 2-23). The mean percentage of loss of initial excess weight at each patient's longest follow-up was 78%. Before surgery, 33 patients were hypertensive (49%), 11 were dyslipidemic (16%), 3 were hyperglycemic, and 2 had type 2 diabetes. At the longest follow-up period after surgery, only 6 patients were hypertensive, and none were dyslipidemic or diabetic. A total of 19 reoperations were performed in 14 patients (20%), including 7 revisions. Eleven patients developed protein malnutrition 1-10 years after BPD. The long-term mortality rate was 4%. At 4 to 23 years after BPD, 18 of the women had given birth to 28 healthy babies. Three women had had a complicated pregnancy. CONCLUSION: Adolescents can undergo malabsorptive bariatric surgery with excellent long-term weight loss results and an incidence of long-term complications similar to that observed during the 30-year evolution of BPD in our experience.

Attitudes of morbidly obese patients to weight loss and body image following bariatric surgery and body contouring.

BACKGROUND: The authors evaluated body image attitudes in post-obese persons following bariatric surgery who require cosmetic and body contouring operations. METHODS: We studied 20 morbidly obese women prior to biliopancreatic diversion (BPD) (OB group), 20 post-obese women at >2 years following BPD (POST group), 10 post-obese women following BPD who required cosmetic procedures (POST-A group), 10 post-obese women after BPD and subsequent cosmetic surgery (POST-B group), and 20 healthy lean controls. Attitudes to weight and shape were evaluated by means of the Body Uneasiness Test (BUT). RESULTS: In comparison with the obese patients in the POST group, lower BUT scores were observed, while in the POST-A group the values were very similar to those observed in the non-operated obese individuals. In the individuals having received cosmetic surgery, the BUT findings were similar to those recorded in the POST group patients, the values approaching data found in the controls. CONCLUSION: Despite a fully satisfactory weight loss and maintenance, the post-BPD individuals requiring aesthetic surgery showed some disparagement of body image; in these subjects, cosmetic and body contouring procedures may actually improve body weight and shape attitudes towards normality.

Type 2 diabetes and weight loss following biliopancreatic diversion for obesity.

BACKGROUND: The authors investigated the weight loss and maintenance in type 2 diabetic obese patients undergoing biliopancreatic diversion (BPD). METHODS: Two series of diabetic and non-diabetic obese patients matched for gender, age and baseline body mass index (BMI) were evaluated prior to BPD, on the occasion of the regular follow-up visit at 1, 2 and 3 years following the operation, and at the fifth postoperative year. At each follow-up point, body weight (BW), BMI, and serum glucose concentration were measured. RESULTS: In all type 2 diabetic patients, the serum glucose level fell to within the normal range at the first postoperative year and remained within normal limits without any medication throughout all the follow-up period. In preoperatively diabetic subjects, mean values of BW and BMI were closely similar to those of non-diabetic subjects at all follow-up points, and the stabilization weight was independently related to age and to initial BW values. CONCLUSIONS: In obese patients with type 2 diabetes, the glucose level steadily normalized in every case following BPD, and values remained unchanged throughout the follow-up period. After the operation, the type 2 diabetic obese patients experienced the same stable weight reduction as their non-diabetic counterparts.

Preoperative resting energy expenditure does not predict weight loss and maintenance after vertical banded gastroplasty.

BACKGROUND: The authors evaluated the predictive efficacy of preoperative resting energy expenditure (REE) on long-term weight loss maintenance following vertical banded gastroplasty (VBG). In the long-term following VBG, low energy expenditure could lead to regain of weight, and thereby REE data might be a reliable predictor of long-term weight outcomes. METHODS: A prospective study was conducted, taking into account the relationship between preoperative REE values and the results at 3 and 5 years following VBG in terms of both weight loss and success of the operation. RESULTS: Long-term weight loss and outcome following VBG appeared to be completely independent of the preoperative REE. CONCLUSION: Preoperative REE cannot predict long-term weight outcome following VBG.

Liver damage in severely obese patients: a clinical-biochemical-morphologic study on 1,000 liver biopsies.

BACKGROUND: Preoperative clinical and biochemical data and intraoperative liver biopsy of 1,000 obese patients submitted to biliopancreatic diversion (BPD) were analyzed, and correlations investigated. METHODS: Of 2,645 patients submitted to BPD between May 1976 and November 2002, the last 1,000 consecutive obese patients with no history of alcohol consumption or infectious hepatitis were selected. Clinical data included: age, body weight, BMI, waist-to-hip ratio (W/H), arterial blood pressure, serum glucose, triglycerides, cholesterol, albumin/gamma-globulin ratio, total, conjugated and unconjugated bilirubin, gamma-GT, alkaline phosphatase, AST, ALT, and prothrombin time. The degree of steatosis, inflammation and fibrosis on intraoperative wedge liver biopsy was determined and scored. Liver steatosis >70% and presence of bridging fibrosis were analyzed separately. RESULTS: Mean BMI was 48 kg/m(2). 263 patients had steatosis of >70%, and 79 had bridging fibrosis. Regression analysis showed an association between steatosis and AST, ALT, AST/ALT ratio, body weight, W/H, serum glucose, serum tryglicerides, BMI, gamma-GT, age, and unconjugated bilirubin. Inflammation was significantly greater in older patients. Patients with bridging fibrosis had significantly higher values of serum glucose, AST, gamma-GT, serum cholesterol and were significantly older. Bridging fibrosis was associated with diabetes, W/H >1, hypertension, albumin/gamma-globulin ratio <1. CONCLUSION: Severe steatosis and bridging fibrosis seem to be associated with the metabolic syndrome. No reliable biochemical data could identify patients with severe chronic liver damage with sufficient sensitivity to avoid liver biopsy for diagnosis and staging of the disease.

Changes in serum ghrelin concentration following biliopancreatic diversion for obesity.

OBJECTIVE: Ghrelin is a recently discovered hormone that is produced mainly by the stomach and that increases food intake in rodents and humans. It has been postulated that the weight loss after gastric bypass surgery for obesity might be related to changes in serum ghrelin concentration. RESEARCH METHODS AND PROCEDURES: Serum leptin and ghrelin concentrations were measured in a group of obese patients before biliopancreatic diversion (BPD) and 2 and 12 months postoperatively. Insulin sensitivity was determined from serum glucose and insulin levels according to the homeostatic model of assessment for insulin resistance (HOMA IR). RESULTS: A sharp drop was observed in body weight, in BMI values, in HOMA IR data, and in serum leptin concentration at 2 and 12 months after BPD, whereas a significant increase of serum ghrelin level was observed at 12 months, when food intake had returned to preoperative levels. A negative correlation between the postoperative changes of serum ghrelin concentration and those of HOMA IR values was observed at 2 and 12 months after BPD. DISCUSSION: No evidence upholding a relationship between serum ghrelin concentration and food intake after BPD was seen; the postoperative changes likely reflected the achievement of a new state of energy balance. The negative relationship observed between post-BPD changes in HOMA IR values and changes in serum ghrelin concentration supported the role of insulin in the modulation of ghrelin production.

A 15-year evaluation of biliopancreatic diversion according to the Bariatric Analysis Reporting Outcome System (BAROS).

BACKGROUND: Biliopancreatic diversion (BPD) is the most effective bariatric procedure in terms of weight loss. However, analysis of the quality of life (QoL) has never been reported. The BAROS, giving a score to each operated patient on weight loss, improvement in medical conditions, QoL, complications and reoperations, has proven to be a standard reference for evaluating bariatric surgery outcomes. METHODS: In order to apply the BAROS to BPD, we sent a questionnaire to 1,800 BPD patients who had been operated between 1984 and 1998. The response-rate was 51.2%. Out of 1,709 questionnaires which actually reached their destination, we had 858 fully compiled returned. There were 615 women. 596 patients had had an ad hoc stomach (AHS) BPD, and 262 had had an ad hoc stomach ad hoc alimentary limb (AHS-AHAL) BPD. RESULTS: According to the scoring key, 3.5% were classified as a failure, 11% were fair results, 22.8% good, 39.5% very good, and 23.2% excellent results. Considering AHS BPD and AHS-AHAL BPD separately,while the mean excess weight percent loss was 70.5+/-23 and 64.7+/-17 respectively, the failure rate was 6% in the first group and 2% in the AHAL group, while 11% and 6% of cases respectively were fair results, 24% and 20% good, 36% and 47% very good, 23% and 25% excellent results. CONCLUSION: The BAROS evaluation of BPD highlights the importance of its flexibility: the new policy of adapting the procedure to individual characteristics caused a drop in the failure rate and an increase in good, very good and excellent results.

Short-term liver function after biliopancreatic diversion.

BACKGROUND: Liver failure after biliopancreatic diversion (BPD) has been reported. Although in our series of 2,515 BPD with a minimum follow-up of 12 months we have never observed this complication, a transitory and significant rise in serum AST and ALT has been detected in some cases, suggesting the occurrence of transient liver damage. To assess if risk factors for acute liver damage after BPD could be identified, we studied the evolution of hepatic biochemistry in a sample of our operated subjects. METHODS: We studied 99 consecutive patients submitted to the same type of BPD (ad hoc stomach, ad hoc alimentary limb). Patients with a history of alcohol consumption or positive hepatic serology were excluded. Preoperative body weight (BW), body mass index (BMI), excess weight (EW), % excess weight (%EW), fasting serum glucose level (SG), hepatic histology (HI), weight loss (WL) at 2, 4 and 12 months, and excess weight % loss (IEW%L) at the same time were correlated with preoperative and 2, 4 and 12 months hepatic biochemistry. RESULTS: Compared with preoperative values, AST levels at 2 months significantly increased (Student's t-test, P=0.0003) and significantly decreased at 12 months (P=0.0001). Spearman's Rank test showed significant correlations between 2 months AST levels and WL at 2 months (P =0.005), preoperative BW (P <0.0001), SG (P =0.01), and HI (inflammation P<0.0001, fibrosis P=0.001). CONCLUSION: Hepatocellular necrosis in our series peaks at 2 months, and decreases afterwards.WL at 2 months, preoperative BW, SG and HI seem to be of help in identifying patients at increased risk for acute liver damage, prompting the need for an enhanced surveillance.

Recovery of insulin sensitivity in obese patients at short term after biliopancreatic diversion.

OBJECTIVE: To gain insight into the specific mechanisms by which biliopancreatic diversion (BPD) can improve insulin action. MATERIALS AND METHODS: Nondiabetic severely obese patients (n=20) undergoing BPD were included. Waist-to-hip ratio and serum concentration of glucose, insulin, and leptin were determined before, at 4-day, and at 2 months after the operation. Insulin sensitivity was calculated according to the homeostatic model assessment (HOMA IR). RESULTS: A marked increase of insulin sensitivity was observed by the fourth day after the operation; at the second postoperative month, when body weight was still in the obese range and the food intake was substantially similar to the preoperative one, a further improvement of insulin action towards normality was found. Moreover, before BPD HOMA IR data were independently correlated both to BMI and waist-to-hip ratio values, whereas at 2 months after the operation data were in positive correlation only with the BMI. DISCUSSION: In obese patients, BPD seems to achieve recovery of insulin sensitivity by specific mechanisms independent of weight loss: the main causes of this sharp improvement might be both the intramyocellular fat depletion and the interruption of enteroinsular axis.

A new approach to the fashioning of the gastroenteroanastomosis in laparoscopic standard biliopancreatic diversion.

A retrocolic submesocolic approach was used for creating the gastroenteroanastomosis in 42 consecutive patients who underwent laparoscopic biliopancreatic diversion for obesity. The surgical technique is described in detail. The laparoscopic gastroenteroanastomosis was successfully performed on all the operated patients, with no intraoperative complications requiring conversion to open surgery and no immediate or late postoperative morbidity related to the anastomosis.

Leptin and insulin action in severely obese women.

BACKGROUND: The authors investigated the interrelationships between the components of the metabolic syndrome in severe obesity. METHODS: In non-diabetic, severely obese women, the degree of obesity (BMI), the insulin sensitivity (from the Homeostatic Model of Assessment, HOMA), the serum leptin concentration and the presence of dyslipidemia and arterial hypertension were evaluated. RESULTS: In insulin-resistant patients, an overall impaired metabolic status and a greater cardiovascular risk were observed, while serum leptin concentration was higher than in the insulin-sensitive ones. Leptin levels and HOMA data correlated independent of BMI findings, while the presence of dyslipidemia and hypertension was unrelated to the other metabolic syndrome factors. CONCLUSION: In severely obese women, although other factors independently intervene, serum leptin has a role in developing the metabolic syndrome.