Vincenzo Bacci

BioEnterics® Intragastric Balloon (BIB®) : a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

Background:The BioEnterics® Intragastric Balloon (BIB®) System in association with restricted diet has been used for the short-term treatment of morbid obesity. Aim of this study was to evaluate the real, short term, efficacy of the BIB for weight reduction in morbidly obese patients by using a prospective, double-blind, randomised, sham-controlled, crossover study.Methods:Patients were recruited from January 2003 to December 2003. After selection, they were randomly allocated into two groups: BIB followed by sham procedure after 3 months (Group A), and sham procedure followed by BIB after 3 months (Group B). All endoscopic procedures were performed under unconscious intravenous sedation. The BioEnterics Intragastric Balloon (Inamed Health; Santa Barbara, CA, USA) was filled by using saline (500 ml) and methylene blue (10 ml). Patients were discharged with omeprazole therapy and diet (1000 kcal). Patients were followed up weekly by a physician blinded to randomisation. In both groups mortality, complications, BMI, BMI reduction and %EWL were considered. Data were expressed as mean±s.d., except as otherwise indicated. Statistical analysis was performed by means of Students t-test, Fishers exact test or χ 2 with Yates correction; P<0.05 was considered significant.Results:A total of 32 patients were selected and entered the study (8M/24F; mean age: 36.2±5.6 years, range 25–50 years; mean BMI 43.7±1.5 kg/m2, range 40–45 kg/m2; mean %EW: 43.1±13.1, range: 35–65). All patients completed the study. Mortality was absent. Complications related to endoscopy, balloon placement and removal were absent. Mean time of BIB positioning was 15±2 min, range 10–20 min. After the first 3 months of the study, in Group A patients the mean BMI significantly (P<0.001) lowered from 43.5±1.1 to 38.0±2.6 kg/m2, while in Group B patients the decrease was not significant (from 43.6±1.8 to 43.1±2.8 kg/m2). The mean %EWL was significantly higher in Group A than in Group B (34.0±4.8 vs 2.1±1%; P<0.001). After crossover, at the end of the following 3 months, the BMI lowered from 38.0±2.6 to 37.1±3.4 kg/m2 and from 43.1±2.8 to 38.8±3.1 kg/m2 in Groups A and B, respectively.Conclusions:The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure. In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet. The BIB® procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients.

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.

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.

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.