Roberta Maselli

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 (6xa0months) followed by diet therapy (7xa0months; group Au2009=u200950 pts), BIB positioning followed by another BIB after 1xa0month (group Bu2009=u200950 pts). Baseline demographics were similar in both groups (Group A 10M/40F; mean age 31.4u2009±u20092.6; range 25–35; mean weight 106.3u2009±u200912.5xa0Kg; range 88–150; mean BMI 42.6±2.7xa0Kg/m2; range 40.2–43.8; Group B 10M/40F; mean age 32.1u2009±u20092.1; range 25–35; mean weight 107.1u2009±u200911.9xa0Kg; range 90–150; mean BMI 42.9u2009±u20092.3; range 40.2–43.9). In both groups, weight loss parameters (Kg, BMI, and % EBL) were considered. Statistics were by Fisher’s exact test (pu2009<u20090.05 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 34.2u2009±u20093.9 (range 32.4–43.8); and mean %EBL 43.5u2009±u200921.1 (range 0–68). Group B: mean weight was 84.9u2009±u200918.3 (range 50–148); mean BMI 34.8u2009±u20093.3 (range 32.4–43.8); and mean % EBL 45.2u2009±u200922.5% (range 0–68). At the study end, weight loss parameters were significantly lower in patients who underwent consecutive BIB (pu2009<u20090.05): mean BMI was 30.9u2009±u20097.2xa0Kg/m2 (range 24–40), and 35.9u2009±u20099.7xa0Kg/m2 (range 34–42); mean % EBL was 51.9u2009±u200924.6% (range 0–100) and 25.1u2009±u200926.2% (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.

Multi-Centre European Experience with Intragastric Balloon in Overweight Populations: 13 Years of Experience

BackgroundThe request to lose weight is expanding not only in obese and morbidly obese patients but also in overweight patients affected by co-morbidities as diabetes and hypertension and who do not tolerate diet regimen or lifestyle changes. The aim of this study is a multicenter evaluation of outcomes of intragastric balloon in overweight patients.MethodsPatients (BMI 27–30xa0kg/m2) treated with a BioEnterics Intragastric Balloon (BIB) between 1996 and 2010 were extracted from the database of the participating centres in Rome (Italy), Liège (Belgium) and Madrid (Spain). Primary endpoints were the efficacy and safety at 6 and 42xa0months from balloon positioning. Secondary endpoints included resolution of co-morbidities.ResultsA total of 261 patients were included in this study. The most common indication for balloon placement was a psychological disorder (54xa0%). Mean body mass index (BMI) fell from 28.6u2009±u20090.4 at baseline to 25.4u2009±u20092.6xa0kg/m2 at 6xa0months and to 27.0u2009±u20093.1xa0kg/m2 at 3xa0years from BIB removal. The mean %EWL was 55.6xa0% at 6xa0months and 29.1xa0% at 3xa0years. Forty-seven patients (18xa0%) had complications associated with placement of the intragastric balloon (leaku2009=u200928, intoleranceu2009=u200914, duodenal ulceru2009=u20092, gastritisu2009=u20091, oesophagitisu2009=u20091, duodenal polypsu2009=u20091). The rate of patients with hypertension decreased from 29xa0% at baseline to 16xa0% at 3xa0years. Diabetes decreased from 15 to 10xa0%, dyslipidaemia decreased from 20 to 18xa0%, hypercholesterolaemia decreased from 32 to 21xa0% and osteoarthropathy decreased from 25 to 13xa0%.ConclusionsThe intragastric balloon is safe and effective in overweight patients, helping to reduce progression to obesity and decreasing the prevalence of a number of important co-morbidities.

Intragastric balloon or diet alone? A retrospective evaluation.

BackgroundVery few studies have reported results of the BioEnterics Intragastric Balloon (BIB®) at ≥12xa0months follow-up. The aim of this study is the retrospective evaluation of the results of BIB placement compared to diet regimen alone.MethodsFrom January 2005 to June 2006, 130 outpatients underwent a structured diet plan with simple behavioral modification at our institutions. Controls (nu2009=u2009130) 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 60xa0g/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 24xa0months from baseline and comorbidities at baseline and after 24xa0months. Results are expressed as mean±standard deviation. Statistical analysis was done by Student’s t-test and χ2-test or Fisher’s exact test. pu2009<u2009.05 was considered significant.ResultsAt the time of BIB removal (6xa0months), significantly better results in terms of weight loss in kilograms (16.7u2009±u20094.7 vs. 6.6u2009±u20092.6; pu2009<u20090.01), BMI (35.4u2009±u200911.2 vs. 38.9u2009±u200912.1; pu2009<u20090.01), %EBL (38.5u2009±u200916.1 Vs 18.6u2009±u200914.3; pu2009<u20090.01), and %EWL (33.9u2009±u200918 vs. 24.3u2009±u200917.0; pu2009<u20090.01) were observed in patients treated by intragastric balloon as compared to diet-treated patients. At 24xa0months from baseline, patient dropout was 1/130 (0.7%) and 25/130 (19.2%) in the BIB and diet groups, respectively (pu2009<u20090.001). At this time, patients treated with intragastric balloon have tended to regain weight, whereas diet-treated patients have already regained most of lost weight.ConclusionsAlthough 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.

Gastroesophageal reflux disease and Barrett’s esophagus after laparoscopic sleeve gastrectomy: a possible, underestimated long-term complication

BACKGROUNDnMorbidly obese patients are affected by gastroesophageal reflux disease (GERD) and hiatal hernia (HH) more frequently than lean patients. Because of conflicting results, the indication to sleeve gastrectomy (SG) in patients with GERD is still debated.nnnOBJECTIVESnTo evaluate the incidence of GERD on the basis of clinical, endoscopic, and histologic data in patients undergoing SG.nnnSETTINGSnUniversity hospital, Rome, Italy.nnnMETHODSnFrom July 2007 to January 2010, 162 patients underwent primary SG. Preoperatively all patients underwent visual analogue scale (VAS) evaluation of GERD symptoms, proton pump inhibitors (PPIs) consumption recording, and esophagogastroduodenoscopy (EGD). Stomach resection started 6 cm from pylorus on a 48Fr bougie. Staple line was reinforced by an oversewing suture. A postoperative clinical control with VAS evaluation, PPI consumption, and EGD was proposed to all patients. Three patients were excluded because of the occurrence of major postoperative complications.nnnRESULTSnA total of 110 patients accepted to take part in the study (follow-up rate: 69.1%). At a mean 58 months of follow-up, incidence of GERD symptoms, VAS mean score, and PPI intake significantly increased compared with preoperative values (68.1% versus 33.6%: P<.0001; 3 versus 1.8: P = .018; 57.2% versus 19.1%: P<.0001) At EGD, an upward migration of the Z line and a biliary-like esophageal reflux was found in 73.6% and 74.5% of cases, respectively. A significant increase in the incidence and in the severity of erosive esophagitis (EE) was evidenced, whereas nondysplastic Barretts esophagus (BE) was newly diagnosed in 19 patients (17.2%). No significant correlations were found between GERD symptoms and endoscopic findings.nnnCONCLUSIONnIn the present series the incidence of EE and of BE in SG patients was considerably higher than that reported in the current literature, and it was not related to GERD symptoms. Endoscopic surveillance after SG should be advocated irrespective of the presence of GERD symptoms.

Laparoscopic sleeve gastrectomy versus intragastric balloon: a case-control study

AimTo compare the efficacy of laparoscopic sleeve gastrectomy (LSG) and BioEnterics intragastric balloon (BIB®) to lose weight and comorbidities after 12xa0months of follow-up before a more invasive bariatric procedure.MethodsFrom January 2004 to December 2006, 40 patients underwent laparoscopic sleeve gastrectomy (LSG) as a first step in biliopancreatic diversion with duodenal switch. Controls (nxa0=xa080) 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 6xa0months (time of BIB removal), and after 12xa0months 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 meanxa0±xa0standard deviation.ResultsMortality, 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 120xa0±xa040 (range 60–200) min. Mean positioning time for BIB was 15xa0±xa05 (range 10–25) min. BMI at baseline was 54.1xa0±xa02.9 (range 45.1–55.9) kg/m2 and 54.8xa0±xa02.5 (range 45.1–56.2) kg/m2 in BIB and LSG groups, respectively. At 6-month follow-up, mean BMI was 46.2xa0±xa03.5 and 45.3xa0±xa05.5xa0kg/m2 in the BIB and LSG patients, respectively [pxa0=xa0not significant (ns)]. After 12xa0months 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.ConclusionsLaparoscopic 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 (12xa0months).

Adjustable Intragastric Balloon vs Non-Adjustable Intragastric Balloon: Case–Control Study on Complications, Tolerance, and Efficacy

BackgroundThe objective of this study is the comparison of a new intragastric balloon recently introduced, the Adjustable Balloon System (ABS), with the BioEnterics intragastric balloon (BIB) in terms of tolerance, safety, and weight loss parameters.MethodsA case–control study was done: 40 patients were matched with 80 controls. To achieve the same duration therapy (12xa0months), a single ABS positioning was compared with a BIB followed by another BIB (6u2009+u20096xa0months). Length of procedure, hospital stay, complications, and weight loss parameters after 6xa0months (time of first BIB removal) and after 12xa0months from baseline (time of Spatz and second BIB removal) were considered. Statistical analysis was done by means of Student’s t test, χ2 test, or Fisher’s test. Pu2009<u20090.05 was considered significant.ResultsMortality, positioning, and extraction complications were absent. Both the devices were well tolerated with slight duration of post placement symptoms. During this study, the Spatz balloon was adjusted with inflation of 200xa0cm3 of saline (total, 800xa0cm3) in 9/40 (22.5xa0%) patients, for poor weight loss after first 6-months treatment. In the Spatz group, there occurred 7/40 complications linked to the device and in 6/7 patients the balloon was removed. At the end of the study, the weight loss parameters were similar between groups: BMI 31.0u2009±u200911.8 (Spatz group) vs 31.3u2009±u200912.3 (BIB group) (pu2009=u2009Ns).ConclusionsThe idea of dynamic balloon therapy needs to be confirmed with wider series. The rate of complication reported is very high, and several studies regarding safety and efficacy are needed.

Long-term results after laparoscopic sleeve gastrectomy in a large monocentric series

BACKGROUNDnLaparoscopic sleeve gastrectomy (SG) has gained great popularity as a stand-alone bariatric procedure because short- and mid-term outcomes in terms of weight loss and resolution of co-morbidities have been very positive. However, long-term results from large series still are sparse.nnnOBJECTIVESnTo evaluate the long-term clinical outcomes of SG in a large series of patients undergoing SG as a stand-alone procedure.nnnSETTINGnUniversity hospital in Italy.nnnMETHODSnA retrospective analysis of prospectively collected data from 182 patients undergoing SG between 2006 and 2008 in the authors institution. Long-term outcomes at 6 and 7 years were analyzed in terms of weight loss and co-morbidities resolution.nnnRESULTSnMean initial body mass index (BMI) was 45.9±7.3 kg/m(2). Major postoperative complications occurred in 8 patients (5.4%): 4 leaks, 2 bleeding, 1 abdominal collection, and 1 dysphagia. All complications were managed conservatively. One hundred forty-eight patients (81.4%) completed the 72-month (6-year) follow-up. Thirty-seven patients (25%) reached a follow-up of 84 months. At year 6 follow-up the mean BMI and the mean percentage of excess weight loss (%EWL) were 30.2 kg/m(2) and 67.3%, respectively. Mean total body weight loss was 44.9 kg, while a %EWL >50 was registered in 123 patients (83.1%). Preoperative BMI did not significantly influence postoperative %EWL. Remission of type 2 diabetes mellitus, arterial hypertension, obstructive sleep apnea syndrome, and gastroesophageal reflux disease symptoms occurred in 83.8%, 59.7%, 75.6%, and 64.7% of patients, respectively.nnnCONCLUSIONn%EWL and resolution of co-morbidities appear to be sustained 6 and 7 years after SG. Preoperative BMI is not predictive for weight loss outcomes.

Intragastric gastric band migration: erosion: an analysis of multicenter experience on 177 patients

BackgroundLaparoscopic adjustable gastric banding (LAGB) has proven to be a safe and effective surgical treatment for morbid obesity. It can be a simple, fast, reversible, anatomy-preserving procedure. Despite these advantages, its long-term efficacy came into question by the occurrence of complications such as intragastric band migration. Consistent information regarding this complication is still lacking. Treatment for migration is still being debated as well. Most of the inconsistencies of these data stem from the very low number of patients reported in single-center experiences or case reports. Lack of multicenter experience is evident. The aim of this study was to perform a retrospective analysis of data on intragastric migration in a large multicenter cohort of patients who underwent LAGB.MethodsA retrospective multicenter study on LAGB patients was performed. Data had been entered into a prospective database of the Italian Group for LapBand® (GILB) since January 1997. Pars flaccida and perigastric positioning were considered along with different kinds of gastric bands by the same manufacturer. Time of diagnosis, mean body mass index (BMI), presentation symptoms, and conservative and surgical therapy of intragastric migration were considered.ResultsFrom January 1997 to December 2009, a total of 6,839 patients underwent LAGB and their data were recorded [5,660 females, 1,179 males; mean age 38.5xa0±xa018.2xa0years (range 21–62xa0years); mean BMIxa0=xa046.7xa0±xa07.7xa0kg/m2 (range 37.3–68.3); excess weight (EW) 61.8xa0±xa025.4xa0kg (range 36–130); %EW 91.1xa0±xa032.4xa0% (range 21–112xa0%)]. A total of 177 of 6,839 (2.5xa0%) intragastric erosions were observed. According to the postoperative time of follow-up, the diagnosis of intragastric migration was made in 74 (41.8xa0%), 14 (7.9xa0%), 38 (21.4xa0%), 40 (22.6xa0%), 6 (3.4xa0%), and 4 (2.2xa0%) banded patients at 6–12, 24, 36, 48, 60, and 72xa0months after banding, respectively. Most of intragastric band migration during the first 2xa0years occurred in bands with no or a few milliliters of filling. In patients with late erosion, the bands were adjusted several times; no band was overfilled but one was filled to the maximum or submaximum with a maximum of two adjustments. Erosions diagnosed during the first 24xa0months were related to the experience of the surgical staff, while late erosions were not.ConclusionsIntragastric band migration or band erosion is a rare, disturbing, and usually not life-threatening complication of gastric banding. Its pathogenesis is probably linked to different mechanisms in early (technical failure in retrogastric passage) or late (band management) presentation. It is usually asymptomatic and there is no pathognomonic presentation. A wide range of therapeutic options are available, from simple endoscopic or laparoscopic removal to early or late band replacement or other bariatric procedure. More experience and more studies are needed to lower its presentation rate and definitively clarify its pathogenesis to address the right therapeutic option.

Intragastric balloon positioning and removal: sedation or general anesthesia?

BackgroundDifferent anesthesiological techniques are currently used for intragastric balloon positioning and removal. The aim of this study is to compare different anesthesiological approaches for balloon positioning and removal in a large multicentric patient population.MethodsRetrospective multicenter study was conducted. From May 2000 to April 2008, 3,824 patients underwent BIB® placement [1,022 male/2,802 female; mean age 39.5xa0±xa014.7xa0years, range 12–71xa0years; mean body mass index (BMI) 44.8xa0±xa09.7xa0kg/m2, range 28.0–79.1xa0kg/m2; excess weight (EW) 59.1xa0±xa029.8xa0kg, range 16–210xa0kg; %EW 89.3xa0±xa031.7, range 21.4–262]. Patients were allocated to three groups according to anesthesiological technique used: conscious sedation (group A), deep sedation (group B), and general anesthesia (group C). Intragastric balloon was placed after diagnostic endoscopy and removed after 6xa0months. Both positioning and removal were done under different protocols. Conscious sedation was obtained with topical lidocaine spray, adding diazepam (0.05–0.1xa0mg/kg iv) or midazolam (0.03–0.05xa0mg/kg iv). Deep sedation was obtained with propofol alone or adding other drugs such as midazolam, meperidine/fentanyl or meperidine/fentanylxa0+xa0midazolam. General anesthesia was obtained with midazolam premedication (0.01–0.02 mg/kg iv) followed by induction with propofol (1–1.5xa0mg/kg iv)xa0+xa0Norcuron (80 mcg/kg iv)xa0+xa0fentanyl (0.5–1 mcg/kg iv), and maintenance with propofol (50–150xa0μg/kg/min) or sevorane. Oxygen saturation, hemodynamic stability, major anesthesiological complications and related mortality, patient satisfaction, time to return to autonomous walking, duration of procedure, and hospital stay were considered.ResultsSedation-related mortality was absent. A significant number of patients with bronchoinhalation during balloon removal was observed with general anesthesia (Pxa0<xa00.001).ConclusionsBIB positioning and removal should be performed under conscious sedation for patient safety and comfort, and technical success.

Effect of Consecutive Intragastric Balloon (BIB®) Plus Diet Versus Single BIB® Plus Diet on Eating Disorders Not Otherwise Specified (EDNOS) in Obese Patients

BackgroundEating disorders are a group of conditions characterised by abnormal eating habits. Greater than 50xa0% of patients with eating disorders have an ‘eating disorder not otherwise specified’ (EDNOS). No specific tools exist to evaluate EDNOS, and patients are identified only with a diagnosis of exclusion from the other eating disorders. The BioEnterics® Intragastric Balloon (BIB®) is used worldwide as a short-term treatment option in obese patients. A new frequency score was used to evaluate the influence of double consecutive BIB® treatment compared with single BIB® treatment followed by diet on four categories of EDNOS (grazing, emotional eating, sweet-eating and after-dinner grazing).MethodsA prospective study allocated 50 obese patients (age range 25–35, BMI range 40.0–44.9) into two groups: BIB® (6xa0months) followed by diet therapy (7xa0months; group A (Nu2009=u200925)) and BIB® placement for 6xa0months followed by another BIB® for 6xa0months, with a 1-month interval between placement (group B (Nu2009=u200925)). Baseline demographics were similar across both groups.ResultsAt the time of removal of the first BIB® device, EDNOS scores in both groups were not significantly different, but decreased significantly from baseline. By the end of the study, all EDNOS scores were significantly lower in patients undergoing consecutive BIB®, compared with single BIB® followed by diet therapy.ConclusionsThe placement of an intragastric balloon in obese patients allows for a reduction in the intensity of grazing, emotional eating, sweet-eating and after-dinner grazing. A more significant reduction in the EDNOS score was observed with two consecutive BIBs®.