Alfredo Genco

BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients

Background: The temporary use of the BioEnterics Intragastric Balloon (BIB) in morbidly obesity is increasing worldwide. The aim of this study is the evaluation of the efficacy of this device in a large population, in terms of weight loss and its influence on co-morbidities. Methods: Data were retrospectively recruited from the data-base of the Italian Collaborative Study Group for Lap-Band and BIB (GILB). After diagnostic endoscopy, the BIB was positioned and was filled with saline (500-700 ml) and methylene blue (10 ml). Patients were discharged with diet counselling (∼1000 Kcal) and medical therapy. The BIB was removed after 6 months. Positioning and removal were performed under conscious or unconscious sedation. Mortality, complications, BMI, %EWL, BMI loss and co-morbidities were evaluated. Results: From May 2000 to September 2004, 2,515 patients underwent BIB (722M/1,793F; mean age 38.9±14.7, range 12-71; mean BMI 44.4±7.8 kg/m2 ; range 28.0-79.1; and mean excess weight 59.5±29.8 kg, range 16-210). BIB positioning was uncomplicated in all but two cases (0.08%) with acute gastric dilation treated conservatively. Overall complication rate was 70/2,515 (2.8%). Gastric perforation occurred in 5 patients (0.19%), 4 of whom had undergone previous gastric surgery: 2 died and 2 were successfully treated by laparoscopic repair after balloon removal. 19 gastric obstructions (0.76%) presented in the first week after positioning and were successfully treated by balloon removal. Balloon rupture (n=9; 0.36%) was not prevalent within any particular period of BIB treatment, and was also treated by BIB removal. Esophagitis (n=32; 1.27%) and gastric ulcer (n=5; 0.2%) presented in patients without a history of peptic disease and were treated conservatively by drugs. Preoperative co-morbidities were diagnosed in 1,394/2,471 patients (56.4%); these resolved in 617/1,394 (44.3%), improved (less pharmacological dosage or shift to other therapies) in 625/1,394 (44.8%), and were unchanged in 152/1,394 (10.9%). After 6 months, mean BMI was 35.4±11.8 kg/m2 (range 24-73) and %EWL was 33.9±18.7 (range 0-87). BMI loss was 4.9±12.7 kg/m2 (range 0-25). Conclusions: BIB is an effective procedure with satisfactory weight loss and improvement in co-morbidities after 6 months. Previous gastric surgery is a contraindication to BIB placement.

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.

Laparoscopic adjustable silicone gastric banding: prospective evaluation of intragastric migration of the lap-band.

Intragastric prosthesis (Lap-Band, BioEnterics Co., Carpinteria, CA, U.S.A.) migration is one of the major long-term complications of laparoscopic adjustable silicone gastric banding. The causes, clinical signs, timing, and overall incidence of band entrapment have not been prospectively investigated in a large series. The purpose of this study was to assess prospectively the incidence of Lap-Band intragastric migration and to establish the safety and effectiveness of minimally invasive band removal. Between January 1996 and June 2000, 148 consecutive patients enrolled in a multidisciplinary bariatric program underwent laparoscopic adjustable silicone gastric banding. In the follow-up treatment, gastrointestinal endoscopy was performed routinely. One hundred twenty-three patients with a minimum follow-up period of 12 months were entered into the study group. Eleven (9.2%) patients had long-term major complications. Intragastric band migration was observed in nine (7.5%) patients. The diagnosis was established by routine endoscopy between 10 and 41 months after surgery. Five erosions occurred in the first 30 cases (learning curve period). In six patients, the band was removed by an intragastric endoscopic-assisted approach avoiding laparotomy. The remaining three patients are under endoscopic surveillance. The results of this study show that routine upper gastrointestinal endoscopy can discover asymptomatic band migrations early. Band erosion did not require emergency treatment and can be removed safely by a minimally invasive approach.

Role of thyrotropin-releasing hormone in stress ulcer formation in the rat

The role of the hypothalamic peptide thyrotropin-releasing hormone in stress ulcer formation was investigated. In experiment 1, TRH was peripherally administered (10 μg/kg) to rats subjected to cold-restraint stress and compared to an inactive peptide; in experiment 2,TRH was administered intracerebroventricularly (0.02, 0.1, and 0.5 μg/kg) to rats with no adjunctive experimental stress; in experiment 3, TRH antiserum was given intracerebroventricularly to rats subjected to stress and compared to normal rabbit serum. When TRH was administered subcutaneously in rats subjected to stress, it significantly aggravated ulcer formation, and this effect was inhibited by atropine and vagotomy. When administered intracerebroventricularly, TRH alone induced, in a dose-dependent fashion, the formation of gastric ulcers. TRH antiserum infused intrace-rebroventricularly inhibited ulcer formation induced by cold-restraint stress. In conclusion, TRH seems to play a role in stress ulcer formation, possibly by a cholinergic mediated mechanism.

Does the intragastric balloon have a predictive role in subsequent LAP-BAND® surgery? Italian multicenter study results at 5-year follow-up

BACKGROUND The intragastric balloon has been reported to be a safe and effective tool for temporary weight loss. The aim of this study is the evaluation of the possible predictive role of intragastric balloon when used before laparoscopic adjustable gastric banding. METHODS A longitudinal multicenter study was conducted in patients with body mass index (BMI)>35 kg/m(2) who underwent gastric banding with the BioEnterics Intragastric Balloon (BIB). After balloon removal (6 mo), patients were allocated into 2 group according to their percentage of excess weight loss (%EWL): group>25 (%EWL>25%) and group<25 (%EWL<25%). Patients from both group underwent laparoscopic adjustable gastric banding (LAGB) 1-3 months after BIB removal. The LAP-BAND AP band was placed in all patients via pars flaccida. Weight loss parameters were considered in both groups. RESULTS From January 2005 to December 2009, 1357 patients were enrolled in this study. Mean BMI at time of BIB positioning was 44.9±8.4 (range 29-82.5). After 6 months, at time of removal, mean BMI was 39.4±7.3. According to the cutoff, patients were allocated into group A (n = 699) and group B (n = 658). At this time the mean BMI was 36.4±6.4 and 42.7±6.9 (P = .001) in groups A and B, respectively. At 1-year follow-up from LAGB, mean BMI was 35.8±6.5 and 40.0±7.4 (P<.001) in groups A and B, respectively. This significant difference was confirmed at 3- and 5-year follow-ups. A similar pattern was observed with the %EWL. CONCLUSION Satisfactory results with BIB are predictive of a positive outcome of LASB at 1, 3, and 5 years after the procedure, and poor results do not inevitably indicate a negative outcome for gastric banding.

Use of Platelet-Rich Plasma to Reinforce the Staple Line During Laparoscopic Sleeve Gastrectomy: Feasibility Study and Preliminary Outcome

AIMS Reinforcement of the staple line is one of the most debated technical aspects concerning laparoscopic sleeve gastrectomy (LSG). Different buttressing methods have been proposed and demonstrated to be effective in reducing the incidence of staple line bleeding, although data concerning their effort on staple line leakage are not consistent. The aim of this study was to ascertain the technical feasibility and to report the preliminary outcomes of laparoscopic use of platelet-rich plasma (PRP) to reinforce the staple line during sleeve gastrectomy. PATIENTS AND METHODS From March 2012 to May 2012, 20 patients were prospectively enrolled (10 females; mean age, 44.6 ± 11 years; mean body mass index, 42.3 ± 5.45 kg/m(2)). Type 2 diabetes mellitus was present in 4 patients, obstructive sleep apnea syndrome in 3, and hypertension in 6. LSG was performed using a 48-French bougie and gold cartridges; reinforcement of the staple lines with buttressed materials or oversewing the suture was performed excluding the last cranial cartridge. PRP was prepared by separating the platelets from autologous blood withdrawn on the same day of surgery, in order to obtain a membrane with cylindrical shape (2×5 cm) formed by fibrin and active platelets. The membrane is introduced through the 10-mm trocar and placed at the upper portion of the staple line. The overall cost for the preparation of PRP is about €15. RESULTS No intraoperative complications and conversions have been recorded during the surgical procedures. No deaths occurred. The mean operative time was 85 ± 31 minutes, which was not significantly increased compared with the operative time of the surgeons overall personal series (750 cases). At 12 months of follow-up the abdominal ultrasound was negative for collections, and upper contrast showed no images indicating gastric leaks. In no case did PRP induce symptoms of rejection, infection, or adverse events. CONCLUSIONS The use of PRP during LSG is feasible, does not increase significantly the operative time, does not require any special devices, and is cost effective. A larger cohort of patients is needed to ascertain the potential effectiveness of PRP in the prevention of postoperative staple line complications.

Intragastric Balloon Treatment for Obesity

The first intragastric balloon was launched in the market 30 years ago. From then, different intragastric prosthesis have been presented and used worldwide. There are, now, one billion overweight/obese persons worldwide. Only some of those patients express the desire or are able to undergo surgical operation. At present there is no medical cure for obesity. Despite the numerous dietary treatments, the natural course of obesity is characterized by an ongoing and sometimes unstoppable weight gain. In patients with first degree obesity, the intragastric balloon interrupts the ongoing and inexorable weight gain, and improves the relevant co-morbidities. In super-obese patients, where there are numerous co-morbidities, the weight loss obtained with the balloon represents a chance to reduce the surgical and anesthesiologic complications deriving from bariatric surgery.

Laparoscopic sleeve gastrectomy as revisional surgery in a vertical gastroplasty with gastrogastric fistula: a simplified technique.

Gastrogastric fistula is one of the complications that can occur after vertical gastroplasty surgery for weight loss. We describe a novel sleeve gastrectomy technique to treat a proximal gastrogastric fistula after vertical gastroplasty.

Lack of correlation between gastroesophageal reflux disease symptoms and esophageal lesions after sleeve gastrectomy

BACKGROUND The postoperative development or worsening of gastroesophageal reflux disease (GERD) represents the major drawback of laparoscopic sleeve gastrectomy (SG). A GERD diagnosis is often based only on symptoms and proton pump inhibitors (PPI) intake, while objective tests like esophagogastroduodenoscopy and pH measurements are performed less frequently. OBJECTIVES To evaluate the association between reflux symptoms and GERD-related esophageal lesions. SETTINGS University hospital, Rome, Italy. METHODS A comprehensive clinical control entailing GERD symptoms, PPI intake, and esophagogastroduodenoscopy was proposed to all patients who underwent SG between June 2007 and February 2011, irrespective of the presence of GERD symptoms. One hundred forty-four of 219 patients agreed to take part in the study (follow-up rate: 65.8%). RESULTS After a mean follow-up of 66 months, GERD symptoms and PPI intake were recorded in 70.2% and 63.9% of patients, respectively. Mean visual analogue scale score was 2.9 ± 3.3. The overall frequency of erosive esophagitis was 59.8%, while nondysplastic Barretts esophagus was detected in 13.1%. The frequency of esophageal biliary reflux was 68%. GERD symptoms and visual analogue scale score were not significantly associated with the development of erosive esophagitis and Barretts esophagus and the severity of the esophageal lesions. Moreover, the frequency of erosive esophagitis and Barretts esophagus in patients consuming PPI were similar to that of patients without PPI. CONCLUSION Symptoms investigation alone is not a reliable tool to diagnose GERD after SG. The use of objective diagnostic tests, such as esophagogastroduodenoscopy, should be carefully considered in the postoperative follow-up schedule of SG patients.

10-year follow-up after laparoscopic sleeve gastrectomy: Outcomes in a monocentric series

BACKGROUND Sleeve gastrectomy (SG) has grown into the most popular bariatric operation. Nevertheless, a scarcity of long-term outcomes are available. OBJECTIVES This study aims at evaluating the long-term percent weight loss (%WL), excess weight loss (%EWL), weight regain (WR), and co-morbidity resolution rates in a single-center cohort undergoing SG as a primary procedure, with a minimum 10-year follow-up. SETTING University hospital, Italy. METHODS One hundred eighty-two morbidly obese patients with body mass index (BMI) 46.6 ± 7.3 kg/m2 underwent SG. Obesity-related co-morbidities (type 2 diabetes, hypertension, sleep apnea, gastroesophageal reflux disease) were investigated. Predictors of dichotomous dependent-variable diabetes remission were computed using a binomial logistic regression. RESULTS Patient retention rate was 77%. Mean %WL was 30.9, %EWL was 52.5%, and WR (≥25% maximum WL) occurred in 10.4%. Baseline BMI significantly (P = .001) and linearly predicted %EWL (10 yr %EWL = 18.951 + initial BMI × .74); the super-obese subgroup generated substantially greater WL compared with those with BMI <50 kg/m2 (%EWL 48.0 ± 18.5 versus 61.5 ± 23.2; P < .001). Type 2 diabetes remission occurred in 64.7%; 42.9% patients developed de novo gastroesophageal reflux disease symptoms postoperatively (P < .0001). CONCLUSIONS SG generates sustained WL and co-morbidity resolution up to 10 years postoperatively. Although a notable portion of patients experience WR, mean %WL persists to exceed 30%, translating in adequate WL also in the long term. Additionally, WR does not seem to impact negatively on co-morbidity resolution. SG represents a safe and effective bariatric operation, which easily grants the possibility to proceed to revisional bariatric surgery in patients with WR or failure to WL.