Intragastric balloon for obesity treatment: results of a multicentric evaluation for balloons left in place for more than 6 months.

BACKGROUND: Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months. MATERIALS AND METHODS: A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. RESULTS: Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. CONCLUSION: Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.

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

BACKGROUND: Laparoscopic 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. METHODS: A 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. RESULTS: From 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 38.5 ± 18.2 years (range 21-62 years); mean BMI = 46.7 ± 7.7 kg/m(2) (range 37.3-68.3); excess weight (EW) 61.8 ± 25.4 kg (range 36-130); %EW 91.1 ± 32.4 % (range 21-112 %)]. A total of 177 of 6,839 (2.5 %) intragastric erosions were observed. According to the postoperative time of follow-up, the diagnosis of intragastric migration was made in 74 (41.8 %), 14 (7.9 %), 38 (21.4 %), 40 (22.6 %), 6 (3.4 %), and 4 (2.2 %) banded patients at 6-12, 24, 36, 48, 60, and 72 months after banding, respectively. Most of intragastric band migration during the first 2 years 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 24 months were related to the experience of the surgical staff, while late erosions were not. CONCLUSIONS: Intragastric 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.

Economic impact of industry-sponsored clinical trials in inflammatory bowel diseases: Results from the national institute of gastroenterology "Saverio de Bellis".

Introduction: The majority of the money spent on possible new medications' clinical trials is accounted for by the innovative pharmaceutical sector, which also stimulates the economy of a nation. The objective of this study was to evaluate the impact of pharmaceutical industry-sponsored clinical trials (ISCTs) in inflammatory bowel diseases (IBDs) towards the national health service (NHS) in terms of avoided costs and leverage effect. Methodology: The research was conducted at National Institute of Gastroenterology, "Saverio De Bellis", Castellana Grotte (Apulia, Italy) collecting data from profit ISCTs of pharmaceutical products conducted over the time period 2018-2020 with focus on inflammatory bowel diseases. After the quantification of health services and drug costs from the latter studies, avoided costs and leverage effects were then estimated. Results: The results on the avoided costs for healthcare facilities deriving from the conduct of clinical studies show that, in relation to the sample of five drug companies participating in our 2018-2020 analysis, out of a total of 235,102.46 €, identified as direct investment, 628,158.21 € of avoided costs for the NHS were measured, with an additional saving (leverage effect) for the NHS of 3.67 € for each € invested by the companies promoting clinical trials. Conclusion: Conducting profit clinical trials has practical benefits and a favourable macroeconomic impact that, by completing its limited resources, helps to sustain one country NHS thanks to the avoided costs while also contributing to locational and industrial policy while guaranteeing novel therapeutics and health services for the patients enrolled.

Intragastric balloon positioning and removal: sedation or general anesthesia?

BACKGROUND: Different 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. METHODS: Retrospective multicenter study was conducted. From May 2000 to April 2008, 3,824 patients underwent BIB(®) placement [1,022 male/2,802 female; mean age 39.5 ± 14.7 years, range 12-71 years; mean body mass index (BMI) 44.8 ± 9.7 kg/m(2), range 28.0-79.1 kg/m(2); excess weight (EW) 59.1 ± 29.8 kg, range 16-210 kg; %EW 89.3 ± 31.7, 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 6 months. Both positioning and removal were done under different protocols. Conscious sedation was obtained with topical lidocaine spray, adding diazepam (0.05-0.1 mg/kg iv) or midazolam (0.03-0.05 mg/kg iv). Deep sedation was obtained with propofol alone or adding other drugs such as midazolam, meperidine/fentanyl or meperidine/fentanyl + midazolam. General anesthesia was obtained with midazolam premedication (0.01-0.02 mg/kg iv) followed by induction with propofol (1-1.5 mg/kg iv) + Norcuron (80 mcg/kg iv) + fentanyl (0.5-1 mcg/kg iv), and maintenance with propofol (50-150 µg/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. RESULTS: Sedation-related mortality was absent. A significant number of patients with bronchoinhalation during balloon removal was observed with general anesthesia (P < 0.001). CONCLUSIONS: BIB positioning and removal should be performed under conscious sedation for patient safety and comfort, and technical success.

Esophageal adenocarcinoma after sleeve gastrectomy: actual or potential threat? Italian series and literature review.

BACKGROUND: Sleeve gastrectomy (SG) leads to esophageal mucosal damage in an elevated percentage of cases, configuring a clinical condition of Barrett's esophagus (BE) in a proportion as high as 15-18.8%. BE may rarely evolve into esophageal adenocarcinoma (EAC). OBJECTIVES: To raise awareness of BE as a precancerous lesion which may progress toward malignancy after this popular bariatric procedure. SETTING: Bariatric referral centers, Italy. METHODS: All patients referred to our bariatric center who developed an EAC after SG between 2012 and 2019 were reviewed and consecutively included in this study. The available scientific literature regarding this complication is additionally reviewed. RESULTS: The 3 male patients comprised in this case series underwent laparoscopic SG between 2012 and 2015 in different bariatric referral centers. Age and body mass index at baseline ranged from 21-54 years and 43.1-75.6 kg/m2, respectively. All patients were lost to follow-up early after surgery (3.7 ± 1.4 months), and were diagnosed with EAC at a mean of 27.3 ± 7.6 months after SG. The 4 reported cases in the scientific literature developed an EAC at a mean of 32.5 ± 23 months from SG. Overall, a diagnosis of EAC was made approximately 30.3 ± 17.1 months postoperatively, which seems relatively and worryingly early after surgery. CONCLUSION: Although the rate and probability of progression from BE to EAC is still not well defined, assuming that the rising popularity and execution of SG leads to a growth in the BE incidence, then the preoperative identification and stratification of cancer risk factors in this subset of patients is strongly encouraged. Clinical and endoscopic follow-ups are essential to allow for prevention and early diagnosis and for epidemiologic data collection purposes.

Laparoscopic adjustable gastric banding via pars flaccida versus perigastric positioning: technique, complications, and results in 2,549 patients.

AIM: Retrospective multicenter analysis of the results of two different approaches for band positioning: perigastric and pars flaccida. METHODS: Data were collected from the database of the Italian Group for LapBand (GILB). Patients operated from January 2001 to December 2004 were selected according to criteria of case-control studies to compare two different band positioning techniques: perigastric (PG group) and pars flaccida (PF group). Demographics, laparotomic conversion, postoperative complications, and weight loss parameters were considered. Data are expressed as mean +/- standard deviation. RESULTS: 2,549 patients underwent the LapBand System procedure [age: 40 +/- 11.7 years; sex: 2,130 female, 419 male; body mass index (BMI): 46.4 +/- 6.9 kg/m(2); excess weight (EW): 60.1 +/- 23.6 kg; %EW: 90.1 +/- 32.4]. During this period 1,343/2,549 (52.7%) were operated via the pars flaccida (PF group) and 1,206/2,549 (47.3%) via the perigastric approach (PG group). Demographics for both groups were similar. Thirty-day mortality was absent in both groups. Operative time was significantly longer in the PG group (80 +/- 20 min versus 60 +/- 40 min; p < 0.05). Hospital stay was similar in the two groups (2 +/- 2 days). Laparotomic conversion was significantly higher in the PG group (6 versus 2 patients; p < 0.001). Overall postoperative complication rate was 172/2,549 (6.7%) and was linked to gastric pouch dilation/slippage (67/172), intragastric migration/erosion (17/172), and tube/port failure (88/172). Gastric pouch dilation and intragastric migration were significantly more frequent in the PG group: 47 versus 20 (p < 0.001) and 12 versus 5 (p < 0.001), respectively. Patients eligible for minimum 3-year follow-up were 1,118/1,206 (PG group) and 1,079/1,343 (PF group). Mean BMI was 33.8 +/- 12.1 kg/m(2) (PG group) and 32.4 +/- 11.7 kg/m(2) (PF group) (p = ns), and mean percentage excess weight loss (%EWL) was 47.2 +/- 25.4 and 48.9 +/- 13.2 in PG and PF groups, respectively (p = ns). CONCLUSIONS: Significant improvement in LapBand System results with regard to laparotomic conversion and postoperative complication rate, with similar weight loss results, was observed in the pars flaccida group.

LapBand System in super-superobese patients (>60 kg/m(2)): 4-year results.

BACKGROUND: Bariatric surgery in superobese (BMI > 50 kg/m(2)) and super-superobese (BMI > 60 kg/m(2)) patients can be a formidable technical and therapeutic challenge because these patients often present multiple medical, surgical, and anesthetic risks. Only a few dedicated reports on different surgical options in this kind of patient population are available. The aim of this study is the evaluation of laparoscopic adjustable gastric banding (LAGB) results in an unselected populations of super-superobese patients operated during the last 4 years. METHODS: Super-superobese (BMI > 60 kg/m(2)) patients who underwent LAGB were recruited from the prospective database of our institution. LapBand System (Allergan, Irvine, CA, USA) was positioned in all cases via pars flaccida, 1-2 cm below the gastroesophageal junction and fixed anteriorly with three non-absorbable stitches. The band was not filled at the time of surgery. Operative time, co-morbidities, laparotomic conversion, intra- and postoperative complications, mortality, and weight-loss-related parameters were considered. Data were expressed as mean +/- standard deviation, except as otherwise indicated. RESULTS: From January 2003 to December 2006, 823 patients underwent a bariatric surgical procedure, 95 of whom (11.5%) were BMI > 60 kg/m(2) (59 F/ 36 M; mean BMI, 62.5 +/- 4.2; range, 60.1-77 kg/m(2); mean age 38.5 +/- 13.5, range 18-61 years old). Mortality, intraoperative, and 30-day major complications were absent. One or more preoperative co-morbidities were diagnosed in 90 of 95 (94.7%) patients. After 1 year, co-morbidity-free patients increased from five of 95 (5.3%) to 27 of 95 (28%; p < 0.001). Patients with three or more co-morbidities decreased from 62 of 95 (65.3%) to 0 (p < 0.001). Mean BMI was 43.6 in 95 of 95, 37.9 in 55 of 55, 29.1 in 11 of 11, and 28.9 in five of five patients at 12, 24, 36, and 48 months, respectively. At the same time, %EWL was 53.6, 69.7, 81.3, and 82.1 and %EBL was 50, 66, 90, and 91. CONCLUSIONS: LAGB can be considered an appropriate bariatric surgical option in super-superobese patients both for low morbidity rate and weight loss. The end-point of BMI < 30 can be achieved with a multidisciplinary follow-up. Additional studies with more patients and longer follow-up are needed to confirm these observations.

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.

Improving Weight Loss by Combination of Two Temporary Antiobesity Treatments.

BACKGROUND: It is generally accepted that the efficacy with an intragastric balloon decreases after the first 4 months of treatment. Aim of this study is to evaluate if the association of a very low-calorie ketogenic diet (VLCKD) can improve the results in terms of weight loss parameters and co-morbidities, as compared to usually prescribed low-calorie diet (LCD). METHODS: For the present study (January 2016-June 2017), 80 patients (20 M/60 F, mean age 37.8 ± 6.1 years; excess weight 56 ± 10 kg; mean BMI 37.2 ± 3.8 kg/m2) underwent Orbera positioning. After 4 months, they were randomized into two groups according to the type of treatment: group A (Bioenterics intragastric balloon - Orbera + VLCKD) (n = 40), and group B (Orbera + LCD) (n = 40). RESULTS: All patients completed the study with good adherence to diet therapy treatment allocation. After the 6-month treatment period, at time of Orbera removal, mean weight loss was 19 kg and 12 kg in groups A and B respectively (p < 0.05). Mean BMI was 28.9 ± 2.8 and 31.6 ± 3.1 kg/m2 (p < 0.05), and %EWL was 33.1 ± 3.3 and 21.1 ± 2.9 (p < 0.05) in groups A and B respectively. During the last 2 months in group A, the mean weight loss was 8 kg, while in Group B, the main weight loss was 3 kg (p < 0.001). The VLCKD treatment induced a more significant reduction of major comorbidities related to metabolic syndrome. CONCLUSIONS: This study clearly indicates the efficacy of the prescription of very low-calorie ketogenic diet improving the efficacy of intragastric balloon positioning.

Hepaticojejunostomy in the treatment of iatrogenic biliary lesions following laparoscopic cholecystectomy. A retrospective study on 51 cases.

BACKGROUND/AIMS: Laparoscopic cholecystectomy is characterized by a higher incidence of iatrogenic biliary lesions. The Authors evaluate the role of hepaticojejunostomy in the treatment of iatrogenic biliary lesions following laparoscopic cholecystectomy in 51 patients observed in the Campania region, Italy from 1991 to 2003. METHODOLOGY: The Authors report the data of a retrospective multicentric study of 51 patients -39 women (76.47%), 12 men (13.53%)-reoperated on for major biliary lesions following laparoscopic cholecystectomy. Hepaticojejunostomy in 20 cases (39.21%) and T-Tube plasty in 20 cases (39.21%) were performed. RESULTS: The mean follow-up was 25.01 months. The mean hospital stay was 25.7 days. 1/51 patients (1.9%) died from intraoperative incontrollable hemorrhage while cumulative postoperative mortality was 9.8% (5/51 patients). Therapeutic success rate of hepaticojejunostomy was 70% with a T-Tube plasty success rate of 65%. 9/51 patients (17.64%) were reoperated while in 4/51 (7.84%) a biliary stent was positioned. In 1/51 patients (1.9%) a biliary cirrhosis and in 3/51 (5.7%) a bioumoral cholestasis was observed. CONCLUSIONS: Laparoscopic cholecystectomy causes a higher incidence of iatrogenic biliary lesions. Hepaticojejunostomy gives better long-term results and lower morbidity compared to T-Tube plasty. Management of septic complications in patients with iatrogenic biliary lesions represents the first therapeutic step.

Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5-year results of a prospective randomized trial.

BACKGROUND: To perform a prospective, randomized comparison of laparoscopic adjustable gastric banding (LAGB) and laparoscopic Roux-en-Y gastric bypass (LRYGB). METHODS: LAGB, using the pars flaccida technique, and standard LRYGB were performed. From January 2000 to November 2000, 51 patients (mean age 34.0 +/- 8.9 years, range 20-49) were randomly allocated to undergo either LAGB (n = 27, 5 men and 22 women, mean age 33.3 years, mean weight 120 kg, mean body mass index [BMI] 43.4 kg/m(2); percentage of excess weight loss 83.8%) or LRYGB (n = 24, 4 men and 20 women, mean age 34.7, mean weight 120 kg, mean BMI 43.8 kg/m(2), percentage of excess weight loss 83.3). Data on the operative time, complications, reoperations with hospital stay, weight, BMI, percentage of excess weight loss, and co-morbidities were collected yearly. Failure was considered a BMI of >35 at 5 years postoperatively. The data were analyzed using Student's t test and Fisher's exact test, with P <.05 considered significant. RESULTS: The mean operative time was 60 +/- 20 minutes for the LAGB group and 220 +/- 100 minutes for the LRYGB group (P <.001). One patient in the LAGB group was lost to follow-up. No patient died. Conversion to laparotomy was performed in 1 (4.2%) of 24 LRYGB patients because of a posterior leak of the gastrojejunal anastomosis. Reoperations were required in 4 (15.2%) of 26 LAGB patients, 2 because of gastric pouch dilation and 2 because of unsatisfactory weight loss. One of these patients required conversion to biliopancreatic diversion; the remaining 3 patients were on the waiting list for LRYGB. Reoperations were required in 3 (12.5%) of the 24 LRYGB patients, and each was because of a potentially lethal complication. No LAGB patient required reoperation because of an early complication. Of the 27 LAGB patients, 3 had hypertension and 1 had sleep apnea. Of the 24 LRYGB patients, 2 had hyperlipemia, 1 had hypertension, and 1 had type 2 diabetes. Five years after surgery, the diabetes, sleep apnea, and hyperlipemia had resolved. At the 5-year (range 60-66 months) follow-up visit, the LRYGB patients had significantly lower weight and BMI and a greater percentage of excess weight loss than did the LAGB patients. Weight loss failure (BMI >35 kg/m(2) at 5 yr) was observed in 9 (34.6%) of 26 LAGB patients and in 1 (4.2%) of 24 LRYGB patients (P <.001). Of the 26 patients in the LAGB group and 24 in the LRYGB group, 3 (11.5%) and 15 (62.5%) had a BMI of <30 kg/m(2), respectively (P <.001). CONCLUSION: The results of our study have shown that LRYGB results in better weight loss and a reduced number of failures compared with LAGB, despite the significantly longer operative time and life-threatening complications.

Is bariatric surgery necessary after intragastric balloon treatment?

BACKGROUND: The use of the Bio-Enterics intra-gastric balloon (BIB) has been shown to be a safe and effective procedure for the temporary treatment of morbid obesity. We conducted a retrospective comparative analysis of the weight loss in patients that after BIB removal underwent bariatric surgery and those who did not wish surgery. METHODS: From January 2000 to March 2004, 182 BIBs were positioned in 175 patients (104 F / 71 M; mean age 37.1+/-11.6 years, range 16-67; mean BMI 54.4 +/- 8.1 kg/m(2), range 39.8-79.5; mean %EW 160.8+/-32.9% range 89-264). Patients were excluded from this study who had emergency BIB removal for balloon rupture (n=2, 1.1%) and for psychological intolerance (n=7, 7.8%). All patients were scheduled for a bariatric operation, before BIB positioning. After BIB removal, a number of patients now declined surgery. Consequently, patients were allocated into 2 groups: Group A in whom BIB removal was followed by bariatric surgery (Lap-Band, laparoscopic gastric bypass, duodenal switch) (n=86); Group B patients who after BIB removal refused any surgical procedure (n=82). Both groups were followed for a minimum of 12 months. Results were reported as mean BMI and %EWL +/- SD. Statistical analysis was done by Student t-test or Fisher's exact test, with P<0.05 considered significant. RESULTS: Mean BMI and mean %EWL in the 166 patients at time of removal were 47.3 +/- 8.1 kg/m(2) and 32.1+/-16.6%, respectively. At the same time, mean BMI was 47.6+/-6.9 and 48.1+/-6.5 kg/m(2) in group A and B (P=NS). At 12 months follow-up (100%), mean BMI was 35.1 kg/m(2) in Group A (BIB + surgery) and 51.7 kg/m(2) in Group B (BIB alone) (P<0.001). CONCLUSIONS: After BIB removal, half (49.4%) of the patients scheduled for surgery refused a bariatric operation. These patients returned to their mean initial weight at 12 months follow-up. Therefore, bariatric surgery after BIB removal is highly recommended.

[Surgical treatment of iatrogenic bile duct injuries following laparoscopic cholecystectomy: analysis of long-term results. Retrospective clinical study in 51 patients operated in the Campania region from 1991 to 2003]. / Trattamento chirurgico delle lesioni iatrogene della via biliare in seguito a colecistectomia videolaparoscopica: analisi dei risultati a distanza. Studio clinico retrospettivo in 51 pazienti operati nella regione Campania dal 1991 al 2003.

An higher incidence rate of iatrogenic bile duct injuries is reported in cholecystectomy performed with the laparoscopy than with the laparotomy approach. The aim of this study was to provide a multicentre report on surgical treatment and the outcome of biliary complications during and following laparoscopic cholecystectomy. A questionnaire was mailed to all surgeons with experience in laparoscopic cholecystectomy in the Campania region. Data were collected from January 1991 to December 2003. Each patient was requested to indicate age, gender, associated diseases, site and type of lesion, surgical experience, diagnosis, treatment and complications. Twenty-six surgeons answered the questionnaire. Fifty-one patients (36 F/15 M; mean age: 42.5 +/- 11.9, range 13-91 years) with bile duct injuries following laparoscopic cholecystectomy were reported. The most frequent lesions were main bile duct partial or total transection. The intraoperative mortality rate was 1/51 (1.9%) due to a complex biliary and vascular injury. The postoperative mortality rate of revision surgery was 5/50 (10%). T-tube positioning (n = 20) and Roux-en-Y hepato-jejunostomy (n = 20) were the procedures most frequently performed. The complication rate in patients treated with the T-tube was significantly higher than in those treated with hepatico-jejunostomy. Surgical treatment of biliary injuries following laparoscopic cholecystectomy was characterized by unusually high mortality and morbidity for a non-neoplastic disease. Roux-en-Y hepato-jejunostomy remains the procedure of choice for these injuries.

The use of bovine pericardial strips on linear stapler to reduce extraluminal bleeding during laparoscopic gastric bypass: prospective randomized clinical trial.

BACKGROUND: A prospective comparison was conducted of extraluminal bleeding following gastric transection with or without staple-line reinforcement by dehydrated bovine pericardium (Peri-Strips Dry--PSD) during laparoscopic Roux-en-Y gastric bypass (LRYGBP). METHODS: From January 2001 to September 2003, 98 consecutive morbidly obese patients underwent LRYGBP. Patients were randomly allocated to 2 groups according to the use (Group A, n= 50) or not (Group B, n= 48) of Peri-Strips Dry. In both groups, mortality, intra- and postoperative early and late complications, operating-time, number of hemostatic clips used, blood transfusion and any specific event directly related to the prosthetic material were prospectively evaluated. Data were expressed as mean +/- SD except as otherwise indicated. Statistical analysis was done by means of Student t-test and Fisher exact test. P-value cut off for statistical significance was set at 0.05. RESULTS: Intra- and postoperative mortality were absent. Intra-operative methylene blue test was positive in 6/48 (12.5%) of Group B patients (P<0.001). Overall laparotomic conversion was 3/98 patients (3.1%). One/48 Group B patient was converted because of unsatisfactory exposure and one for linear stapler misfire. One/50 Group A patients was converted for short gastric vessels bleeding during dissection. No patients were re-operated or transfused because of extraluminal bleeding. Mean number of clips used was significantly lower in Group A patients (5 vs 23, P<0.001). The operating-time was significantly less in Group A patients (120+/-60 vs 220+/-100 minutes, P<0.01). CONCLUSIONS: Gastric staple-lines reinforced with Peri-Strips Dry result in a significant reduction in the number of Endo-clips used and prevent bleeding. A dry operating field was obtained, and operating-time was significantly reduced. No adverse events could be related to the use PSD.

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.

Adjustable intragastric balloon vs non-adjustable intragastric balloon: case-control study on complications, tolerance, and efficacy.

BACKGROUND: The 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. METHODS: A case-control study was done: 40 patients were matched with 80 controls. To achieve the same duration therapy (12 months), a single ABS positioning was compared with a BIB followed by another BIB (6 + 6 months). Length of procedure, hospital stay, complications, and weight loss parameters after 6 months (time of first BIB removal) and after 12 months 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. P < 0.05 was considered significant. RESULTS: Mortality, 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 200 cm(3) of saline (total, 800 cm(3)) in 9/40 (22.5 %) 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 31.0 ± 11.8 (Spatz group) vs 31.3 ± 12.3 (BIB group) (p = Ns). CONCLUSIONS: The 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.

Multi-centre European experience with intragastric balloon in overweight populations: 13 years of experience.

BACKGROUND: The 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. METHODS: Patients (BMI 27-30 kg/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 42 months from balloon positioning. Secondary endpoints included resolution of co-morbidities. RESULTS: A total of 261 patients were included in this study. The most common indication for balloon placement was a psychological disorder (54%). Mean body mass index (BMI) fell from 28.6 ± 0.4 at baseline to 25.4 ± 2.6 kg/m2 at 6 months and to 27.0 ± 3.1 kg/m2 at 3 years from BIB removal. The mean %EWL was 55.6% at 6 months and 29.1% at 3 years. Forty-seven patients (18%) had complications associated with placement of the intragastric balloon (leak = 28, intolerance = 14, duodenal ulcer = 2, gastritis = 1, oesophagitis = 1, duodenal polyps = 1). The rate of patients with hypertension decreased from 29% at baseline to 16% at 3 years. Diabetes decreased from 15 to 10%, dyslipidaemia decreased from 20 to 18%, hypercholesterolaemia decreased from 32 to 21% and osteoarthropathy decreased from 25 to 13%. CONCLUSIONS: The 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.

Effect of consecutive intragastric balloon (BIB®) plus diet versus single BIB® plus diet on eating disorders not otherwise specified (EDNOS) in obese patients.

BACKGROUND: Eating disorders are a group of conditions characterised by abnormal eating habits. Greater than 50 % 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). METHODS: A prospective study allocated 50 obese patients (age range 25-35, BMI range 40.0-44.9) into two groups: BIB® (6 months) followed by diet therapy (7 months; group A (N = 25)) and BIB® placement for 6 months followed by another BIB® for 6 months, with a 1-month interval between placement (group B (N = 25)). Baseline demographics were similar across both groups. RESULTS: At 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. CONCLUSIONS: The 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®.

Air-filled vs water-filled intragastric balloon: a prospective randomized study.

BACKGROUND: The positioning of an intragastric saline-filled balloon has been developed as temporary and reversible therapeutic option for treatment of morbid obesity. Recently, an air-filled balloon was also developed. The aim of this study is to prospectively compare these two devices in terms of weight loss parameters, safety, and tolerance. METHODS: Sixty patients were randomized into two groups: group A (Bioenterics Intragastric Balloon-BIB; n = 30; 20 F/10 M, mean age 36.7 ± 10.9; mean BMI 46.5 ± 5.9) and group B (Endobag-Heliosphere; n = 30; 20 F/10 M, mean age 37.8 ± 10.6; mean BMI 46.1 ± 5.6). All patients of both groups were sedated with midazolam (5 mg) + Propofol (2 mg/kg i.v.). The Heliosphere Bag was air-filled with 950 ml while BIB® was inflated with 500 ml of saline and 10 ml of methylene blue. Percentage of excess weight loss (%EWL) and body mass index (BMI) were evaluated. Student t test, Fisher exact test, and χ(2) test were used for statistical analysis. RESULTS: Similar weight loss parameters were observed in patients treated with liquid or air-filled balloon at time of removal: mean BMI was 40.8 ± 6.2 and 41.9 ± 6.5(p = ns), and mean %EWL was 20 ± 12 and 18 ± 14 (p = ns) in groups A and B, respectively. Significant longer extraction time, with high patient discomfort, was observed in group B due to difficult passage through the cardia and the lower pharynx. CONCLUSIONS: Air-filled balloon can be another valid therapeutic option in the temporary treatment of obesity, but at this time, the quality of the device must be improved to ameliorate the patient compliance at removal and avoid the spontaneous deflations.