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).

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.

Reoperation after laparoscopic adjustable gastric banding: analysis of a cohort of 500 patients with long-term follow-up.

BACKGROUND: To assess the rates and causes of reoperations in a long-term follow-up of a cohort of morbidly obese patients treated by laparoscopic adjustable gastric banding. METHODS: A retrospective study was performed to evaluate a cohort of 498 consecutive patients who had undergone laparoscopic adjustable gastric banding since 1996. The first 50 patients were excluded to avoid the learning curve bias. A perigastric technique was used until 2002 (37% of patients) and was then rapidly replaced by a pars flaccida approach. The patients who underwent band removal or port reposition/removal were considered, respectively, as having required a major or minor reoperation. RESULTS: Of the 448 patients (83% women) followed up for an average of 3.2 +/- 2.2 years, 79 (mean age 37.7 years, mean body mass index 44.0 kg/m(2)) underwent repeat surgery between 1997 and 2006. Of these procedures, 29 were minor and 59 were major reoperations. Ten patients underwent band removal after a port complication developed. The main causes were pouch dilation (37%), insufficient weight loss (20%), erosion (20%), and psychological (15%). Ten patients underwent revisional surgery. A 13% incidence of major reoperations was observed for the entire group; the rate of major and minor reoperations was 4.1 and 2.1 interventions per 100 persons-years, respectively. In patients with follow-up >5 years (perigastric technique), the cumulative incidence reached 24%. CONCLUSION: The need for a major reoperation appears to be substantial in patients who have undergone laparoscopic adjustable gastric banding, particularly when the long-term follow-up data are considered, and can occur at any point after surgery. More severe obesity (body mass index >50 kg/m(2)) seems to carry a greater risk of reoperation. These findings highlight the need for lifelong multidisciplinary management and surveillance for these patients.

Association between a novel variant of the human type 2 deiodinase gene Thr92Ala and insulin resistance: evidence of interaction with the Trp64Arg variant of the beta-3-adrenergic receptor.

Thyroid hormone action is an important determinant of energy and glucose metabolism. T4 metabolism is regulated by the deiodinases of which type 2 is expressed in humans in skeletal muscle and brown adipose tissue, where its transcription is stimulated by the beta-3 adrenergic pathway. We performed molecular scanning of the human type 2 deiodinase (DIO2) gene and evaluated a novel variant for associations with obesity and insulin resistance, assessing both the main effect and interaction with the Trp64Arg beta-3--adrenergic receptor (ADRB3) variant. Molecular scanning of DIO2 in 50 obese Caucasians demonstrated a Thr92Ala variant. Association studies in 972 nondiabetic patients, 135 of whom underwent euglycemic-hyperinsulinemic clamps, showed that subjects with the Thr92Ala variant had lower glucose disposal rate (0.54 plus minus 0.02 mg center dot min(-1) center dot kg(-1) fat-free mass Ala92 homozygotes vs. 0.44 plus minus 0.02 Ala92 heterozygotes vs. 0.42 plus minus 0.04 Thr92 homozygotes, P = 0.0088). Association analysis of the entire group showed significant evidence for a synergistic effect between the Thr92Ala DIO2 and Trp64Arg ADRB3 variants on BMI (both variants 34.3 plus minus 0.9 kg/m(2) vs. neither variant 33.1 plus minus 0.4 kg/m(2), P = 0.04 for interaction). To our knowledge, Thr92Ala is the first description of a missense mutation of DIO2. This variant strongly associates with insulin resistance and, in subjects with the Trp64Arg ADRB3 variant, an increased BMI, suggesting an interaction between these two common gene variants.

Results after laparoscopic adjustable gastric banding in patients over 55 years of age.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) has become the most popular bariatric intervention in Europe. International guidelines recommended age limits for bariatric surgery of 18-60 years. The aim of this study was to evaluate the immediate results in morbidly obese patients >55 years old, treated with LAGB. METHODS: Between January 1996 and January 2004, 350 patients underwent LAGB. 24 (6.8%) were >55 years old (Group A), mean age 58.6+/-3.3 years, mean preoperative BMI 42.3+/-4.5 kg/m2. A comparative randomized analysis with 24 patients younger than age 55 years was performed (Group B: mean age 41.2+/-9.6 years, mean BMI 42.1+/-3.6 kg/m2). Baseline clinical features, operative parameters and postoperative results were evaluated. RESULTS: No perioperative complications were recorded. Conversion rate and mortality were nil. Major postoperative complications occurred in 2 patients (8.3%) from Group A (1 intragastric prosthesis migration, 1 pouch dilatation) and 2 patients (8.3%) from Group B (intragastric migrations). Reoperation was needed in 3 cases, and one erosion (Group B) is on the waiting list for removal. Minor complications: 1 port infection in each group required ambulatory port substitution; 1 intraperitoneal portcatheter disconnection (Group B) was successfully treated laparoscopically. Mean follow-up was 31.7 months (Group A) and 33.0 months (Group B). Mean postoperative BMI at 12 and 24 months was 35.9+/-4.2 and 33.8+/-4.9 for Group A, and 33.8+/-4.6 and 33.2+/-6.0 for Group B. CONCLUSION: There have been no significant differences in results between the 2 groups. LAGB has been safe and effective in patients >55 years old.

Different plasma ghrelin levels after laparoscopic gastric bypass and adjustable gastric banding in morbid obese subjects.

Gastric bypass has been reported to be associated with markedly suppressed plasma ghrelin levels, suggesting that it is one of the possible weight-reducing factors related to this procedure. The aim of this study was the evaluation of plasma ghrelin levels in patients who had undergone laparoscopic Roux-en-Y gastric bypass (LRYGBP) and laparoscopic adjustable silicone gastric banding (LASGB). Normoweight, obese subjects and patients who had undergone total gastrectomy were used as controls. In this cross-sectional study, we selected 10 subjects who underwent LASGB, 11 subjects with LRYGBP, 10 obese subjects, eight patients with total gastrectomy, and eight normoweight subjects. Plasma ghrelin, insulin, and glucose profiles were determined before and after breakfast and lunch. Obese subjects showed a ghrelin plasma level significantly lower than normoweight subjects (407.3 +/- 21.6 vs. 813 +/- 72.4 pg/ml, P < 0.01). Patients with LRYGBP showed baseline ghrelin levels lower than LASGB (213.5 +/- 73.9 vs. 314.2 +/- 84.3 pg/ml, P = 0.04). Both groups of patients who underwent bariatric surgical procedures also had ghrelin lower than normoweight and obese subjects (P < 0.01 and P < 0.05, respectively). Patients with total gastrectomy showed plasmatic ghrelin levels extremely lower than those in all other groups (32.6 +/- 18.7 pg/ml, P < 0.001 for all). The ghrelin profile in both groups of subjects who underwent LRYGBP and LASGB did not show any meal-related changes as observed in obese and normoweight control groups. Significant difference in plasma ghrelin levels between LRYGBP and LASGB was found, suggesting that both procedures could induce weight loss by different mechanisms in which ghrelin could be involved.

Modifications of metabolic and cardiovascular risk factors after weight loss induced by laparoscopic gastric banding.

BACKGROUND: The well-known inverse relation between life expectancy and BMI, particularly in morbid obesity, is presumably in large part due to multiple cardiovascular and metabolic comorbidities. Severely obese patients treated with laparoscopic adjustable silicone gastric banding (LASGB) were evaluated for such risk factors before and 1 year after LASGB. METHODS: 130 individuals (age 20-66, BMI 34-59 kg/m2) who underwent LASGB between 1996 and 2000 were studied; 50 of them were available for reevaluation 12 months after surgery. The presence and severity of diabetes (DM), hypertension (HTN), hypercholesterolemia (HC) and hypertriglyceridemia (HT) were assessed before and after surgery. In 18 of them erythrocyte sedimentation rate (ESR) were also measured. RESULTS: Comorbidities were highly prevalent at the initial evaluation: DM 10%, HTN 32%, HC 37%, HT 27%. In the subgroup reevaluated after surgery, prevalence of DM decreased from 15% to 6%, HTN from 37% to 25%, HC from 36% to 25%, and HT from 29% to 13%, with an average BMI loss from 44.1 to 35.9. ESR decreased from a preoperative value of 36.7 +/- 22.6 mm/hr to 18.3 +/- 11.9 mm/hr at 1 year (p < 0.001). CONCLUSION: Morbidly obese subjects respond to LASGB with an impressive reduction of comorbidities which is sustained for at least 1 year, well after the initial acute negative energy balance and when weight tends to stabilize. The high prevalence of elevated ESR, which has been considered a strong predictor of coronary mortality, confirms previous reports of its association with obesity, and the clear tendency to normalization with weight loss may represent a further element contributing to lower morbidity.

Role of a minimally invasive approach in the management of laparoscopic adjustable gastric banding postoperative complications.

HYPOTHESIS: Complications after laparoscopic adjustable gastric banding as treatment for morbid obesity may require a major reintervention. A minimally invasive approach represents an attractive management alternative for such complications. DESIGN: Prospective case series. SETTING: Major academic medical and surgical center. PATIENTS: From January 1996 to July 2003, 47 patients who had undergone laparoscopic adjustable gastric banding were operated on again. Considering the causes for reoperation, the patients were divided into 4 groups: group A had major complications (n = 26); group B, minor complications (n= 11); group C, psychological problems (n=6); and group D, insufficient weight loss (n=4). INTERVENTIONS: Forty-three procedures, 38 using general anesthesia (groups A, C, and D) and 5 using local anesthesia (group B), were performed. MAIN OUTCOME MEASURES: Feasibility, safety, and effectiveness of a minimally invasive approach in the treatment of laparoscopic adjustable gastric banding complications. RESULTS: In group A, 9 of 10 patients with irreversible gastric pouch dilatation and 15 of 16 with intragastric band migrations were treated laparoscopically. In group B, 5 ports were substituted and 2 reconnections of the catheter-port system were performed. In group C, 6 laparoscopic band removals were carried out. In group D, 4 laparoscopic revision procedures for insufficient weight loss were performed. The operative mortality was nil. The most frequent cause of reoperation was intragastric migration (37.2%). A minimally invasive approach was adopted in 94.7% of cases. CONCLUSION: Laparoscopy is safe and effective, even as a second operative procedure.

Vitamin D status and supplementation in morbid obesity before and after bariatric surgery.

Interest in vitamin D has increased recently because of its role on multiple biologic mechanisms and the high prevalence of deficits, particularly in obese individuals. The epidemic of morbid obesity has led to a growing number of bariatric surgical procedures, the only therapeutic modality with a reasonable chance of success on a long-term basis. Vitamin D status following bariatric surgery depends on several interacting factors and should be monitored carefully. We review vitamin D, calcium and parathyroid hormone dynamics following the main types of bariatric surgery and the guidelines for the postoperative periodic assessment and therapy.

Intragastric balloon followed by diet vs intragastric balloon followed by another balloon: a prospective study on 100 patients.

Aim of this study is to compare the efficacy of BioEnterics Intragastric Balloon (BIB®) followed by diet with BIB followed by another BIB. A prospective study was designed: a homogeneous group of 100 obese patients (age range 25-35, BMI range 40.0-44.9, M/F ratio 1/4) was allocated into two groups according to procedure: BIB (6 months) followed by diet therapy (7 months; group A = 50 pts), BIB positioning followed by another BIB after 1 month (group B = 50 pts). Baseline demographics were similar in both groups (Group A 10M/40F; mean age 31.4 ± 2.6; range 25-35; mean weight 106.3 ± 12.5 Kg; range 88-150; mean BMI 42.6±2.7 Kg/m(2); range 40.2-43.8; Group B 10M/40F; mean age 32.1 ± 2.1; range 25-35; mean weight 107.1 ± 11.9 Kg; range 90-150; mean BMI 42.9 ± 2.3; range 40.2-43.9). In both groups, weight loss parameters (Kg, BMI, and % EBL) were considered. Statistics were by Fisher's exact test (p < 0.05 was considered significant). At the time of 1st BIB removal, weight loss parameters in both groups were not significantly different: Group A: mean weight was 83.7±19.1 (range 52-151); mean BMI 34.2 ± 3.9 (range 32.4-43.8); and mean %EBL 43.5 ± 21.1 (range 0-68). Group B: mean weight was 84.9 ± 18.3 (range 50-148); mean BMI 34.8 ± 3.3 (range 32.4-43.8); and mean % EBL 45.2 ± 22.5% (range 0-68). At the study end, weight loss parameters were significantly lower in patients who underwent consecutive BIB (p < 0.05): mean BMI was 30.9 ± 7.2 Kg/m(2) (range 24-40), and 35.9 ± 9.7 Kg/m(2) (range 34-42); mean % EBL was 51.9 ± 24.6% (range 0-100) and 25.1 ± 26.2% (range 0-100) in group B and A, respectively. As compared with diet, a second intragastric balloon can be positioned without difficulties, achieving good results with continuous weight loss.