Francesco Furbetta

Lap Band adjustable gastric banding system: the Italian experience with 1863 patients operated on 6 years.

Background: The Lap Band system procedure is currently the most common bariatric surgical procedure worldwide. This is an interim report of the experience of the 27 Italian centers participating in the national collaborative study group for Lap Band® (GILB). Methods: An electronic database was specifically created. It was mailed and e-mailed to all of the surgeons now performing the laparoscopic gastric banding operation in Italy. Results: Beginning in January 1996, 1893 patients were recruited for the study. There were 1534 women and 359 men with a mean body mass index (BMI) of (range 30.4–83.6) and a mean age of 37.8 ± 10.9 years (range; 17–74). The mortality rate has been 0.53% (n = 10), mainly due to cardiovascular complications (myocardial infarction, pulmonary embolism). The laparotomic conversion rate has been 3.1% (59/1893) and was higher in superobese patients (BMI>50) than in to morbidly obese patients (BMI <50) (p <0.05). Postoperative complications occurred in 193 patients (10.2%), including tube port failure (n = 79; 40.9%), gastric pouch dilation (GPD) (n = 93; 48.9%), and gastric erosion (n = 21, 10.8%). Most GPD (65.5%) occurred during the first 50 patients treated at each center. The incidence of GPD decreased as the surgeons acquired more experience. Surgery for complications was often performed by laparoscopic access, rarely via laparotomy. No death was recorded as a consequence of surgery to treat complications. Weight loss has been evaluated at the following intervals: 6, 12, 24, 36, 48, 60, and 72 months, with BMI 37.9, 33.7, 34.8, 34.1, 32.7, 34.8, and 32. Conclusions: The Lap Band system procedure has a very low mortality rate and a low morbidity rate and it yields satisfactory weight loss. Surgery for complications can be performed safely via laparoscopic access.

Laparoscopic Italian Experience with the Lap-Band®

Background: An increasing number of surgeons with different levels of experience with laparoscopic surgery and open obesity surgery have started to perform laparoscopic implantation of the Lap-Band®. Methods: An electronic patient data sheet was created and was mailed and e-mailed to all surgeons performing laparoscopic adjustable silicone gastric banding (LASGB) in Italy. Patients were recruited since January 1996. Data on 1,265 Lap-Band System® operated patients (258 M / 1,007 F; mean BMI 44.1, range 27.0-78.1; mean age 38, range 17-74 years) were collected from 23 surgeons performing this operation. Results: Intra-operative mortality was absent. Post-operative mortality was 0.55% (7 patients) for causes not specifically related to LASGB implantation. The laparotomic conversion rate was 1.7% (22 patients). LASGB related complications occured in 143 patients (11.3%). Pouch dilatation was diagnosed in 65 (5.2%), and 28 (2.2%) of these underwent re-operation. Band erosion was observed in 24 patients (1.9%). Port or connecting tube-port complications occurred in 54 patients (4.2%), 12 of whom required revision under general anesthesia. Follow-up was obtained at 6, 12, 18, 24, 36 and 48 months, and mean BMI was respectively 38.4, 35.1, 33.1, 30.2, 32.1 and 31.5. The percentage of patients observed at each follow-up was >60%. There was no intra-operative mortality and no complication-related mortality, with acceptable weight loss. Conclusion: The LASGB operation is safe and effective, and deserves wider use for treatment of morbid obesity.

Italian Group for Lap-Band System®: Results of Multicenter Study on Patients with BMI ≤35 kg/m2

Background: The Lap-Band System® is the most common bariatric operation world-wide. Current selection criteria do not include patients with BMI ≤ 35. We report the Italian multicentre experience with BMI ≤ 35 kg/m2 over the last 5 years. Patients and Methods: Data were obtained from 27 centres involved in the Italian Collaborative Study Group for Lap-Band System®. Detailed information was collected on a specially created electronic data sheet (MS Access 2000) on patients operated in Italy since January 1996. Items regarding patients with BMI ≤ 35 were selected. Data were expressed as mean ± SD except as otherwise indicated. Results: 225 (6.8%) out of 3,319 Lap-Band® patients were recruited from the data-base. 15 patients, previously submitted to another bariatric procedure (BIB =14; VBG= 1) were excluded. 210 patients were eligible for study (34M/176F, mean age 38.19±11.8, range 17-66 years, mean BMI 33.9±1.1, range 25.1-35 kg/m2, mean excess weight 29.5±7.1, range 8-41). 199 comorbidities were diagnosed preoperatively in 55/210 patients (26.2%). 1 patient (0.4%) (35 F) died 20 months postoperatively from sepsis following perforation of dilated gastric pouch. There were no conversions to laparotomy. Postoperative complications presented in 17/210 patients (8.1%). Follow-up was obtained at 6, 12, 24, 36, 48 and 60 months. At these time periods, mean BMI was 31.1±2.15, 29.7±2.19, 28.7±3.8, 26.7±4.3, 27.9±3.2, and 28.2±0.9 kg/m2 respectively. Co-morbidities completely resolved 1 year postoperatively in 49/55 patients (89.1%). At 60 months follow-up, only 1 patient (0.4%) has a BMI >30. Conclusions: Although surgical indications for BMI ≤ 35 remain questionable, the Lap-Band® in this study demonstrated that all but 1 patient achieved normal weight, and most lost their co-morbidities with a very low mortality rate.

Results of the Italian Multicenter Study on 239 Super-obese Patients Treated by Adjustable Gastric Banding

Background: Laparoscopic adjustable gastric banding (LAGB) is the most common bariatric operation. This study is a retrospective analysis of the multicenter Italian experience in patients with BMI >50 over the last 4 years. Methods: An electronic data sheet made for LAGBoperated patients since January 1996, was mailed and e-mailed to all surgeons involved in this kind of procedure in Italy. Items regarding patients with BMI >50 were selected. Analysis used Fishers exact test and logarithmic regression analysis (P<0.05 significant). Data were expressed as mean ± SD. Results: 239 patients (13.3%), out of 1,797 LapBand® operated patients entered the study (179F / 60M), with mean age 37.6±11.3 years (19-69) and mean BMI 54.6±4.8 (50.1-83.6). Laparotomic conversion rate was 5.4% (44/239). Postoperative complications occurred in 24 / 239 patients (9.0%). Follow-up was obtained in 218 / 218, 198 / 198, 121 / 147, 75 / 93, 30 / 38 LAGB patients at 6, 12, 24, 36, and 48 months respectively. At these time periods, mean BMI was 46.7, 43.9, 42.2, 41.9, and 39.3 kg/m2. At the same intervals, mean %EWL was 24.1, 34.1, 38.8, 38.9, and 52.9%.The number of patients with <25% EWL at 12, 24, 36, and 48 months follow-up were 34, 10, 4, and 0. Serious co-morbidities (189 in 124 of 239, 57%) had completely resolved 1 year postoperatively in 74 / 124 of the patients (59.6%). Conclusion: Although super-obese patients following the LAGB remain obese with BMI >35, in the short-term most lose their co-morbidities, with a very low morbidity and mortality rate.

The Italian Group for LAP-BAND: predictive value of initial body mass index for weight loss after 5 years of follow-up

BackgroundLaparoscopic of the LAP-BAND System placement stage of obesity is a safe operation, but its indication in terms of stage of obesity is controversial. The aim of this study was to evaluate the 5 years stage of obesity results for weight loss in patients with varying preoperative ranges of body mass index (BMI).MethodsData were obtained from the Italian Collaborative Study Group for LAP-BAND System (GILB) registry. Detailed information was collected on a specifically created database (MS Access 2000) for patients operated on in Italy from January 1996 to 2003. Patients operated on between January 1996 and December 1997 were allocated to four groups according to preoperative BMI range: 30–39.9 kg/m2 (group A), 40–49.9 kg/m2 (group B), 50–59.9 kg/m2 (group C), and =60 kg/m2 (group D) percent estimated weight loss respectively. Postoperative complications, mortality, BMI, BMI loss, and (%EWL) were considered in each group. Data are expressed as mean ± SD, except as otherwise indicated. Statistical analysis was done by means of Fisher’s exact test, and p < 0.05 was considered significant.ResultsAfter 5 years from LAP-BAND System surgery, 573 of 3,562 patients were eligible for the study. One hundred fifty-five of 573 (27.0%) were lost to follow-up, 24 of 418 (5.7%) underwent band removal due to complications (gastric pouch dilation, band erosion), eight of 418 (1.9%) were converted to other bariatric procedures, five of 418 (1.2%) died of causes not related to the operation or the band, and 381 of 573 (66.5%) were available for follow-up. Based on 96, 214, 64, and seven patients their preoperative BMI, Were allocated to groups A, B, C, and D, respectively. At time of follow-up mean BMI was 27.5 ± 5.2 in group A, 31.6 ± 4.7 in group B, 37.6 ± 17.3 in group C, and 41.4 ± 6.9 kg/m2 in group D. Mean BMI loss was 9.8 ± 5.4, 12.9 ± 5.2, 15.8 ± 8.1, and 23.2 ± 4.9 kg/m2, respectively, in groups A, B, C, and D. Mean %EWL at the same time was 54.6 ± 32.3 in group A, 54.1 ± 17.2 in group B, 51.6 ± 35 in group C, and 59.l ± 17.1 in group D.ConclusionInitial BMI in this series did not correlate with %EWL 5 years after the operation. In fact %EWL was almost the same in each group, independent of preoperative weight. Initial BMI was an accurate indicator of the results obtained 5 years after LAP-BAND in group C (50–59.9 kg/m2) and D (=60 kg/m2) patients, who remained morbidly obese despite their %EWL.

Improvement in health-related quality of life in first year after laparoscopic adjustable gastric banding

BACKGROUND We analyzed the health-related quality of life (HRQOL) and its determinants in the first year after laparoscopic adjustable gastric banding (LAGB). The setting was 10 Italian public and private bariatric surgery centers. METHODS Data collected in an ongoing, prospective, 3-year multicenter Italian study on the changes in HRQOL after LAGB were used. HRQOL was investigated using the Medical Outcomes Study Short-Form 36 questionnaire. Hunger, satiety, and the self-perceived effects of LAGB were recorded. RESULTS A total of 334 patients were enrolled. The follow-up rate was 92.2%. The percentage of excess weight loss was 39.6% ± 25.8%, with very few side effects or complications. Hunger in the morning (0-10 scale) was 4.5 ± 2.7 before surgery and 3.8 ± 2.4 after 1 year (P <.001). Satiety after a meal (0-10 scale) was 7.1 ± 2.7 before surgery and 8.2 ± 1.9 at 1 year (P <.001). The self-perceived effect of LAGB on caloric intake (0-10 scale) was 8.4 ± 1.9 after 1 year. The scores for the 8 Medical Outcomes Study Short-Form 36 subscales were significantly improved after surgery. The physical component summary score was 52.6 ± 11.9 at baseline and 79.1 ± 15.6 after 1 year (P <.001). The corresponding mental component summary scores were 52.2 ± 12.3 and 76.5 ± 17.2 (P <.001). Greater physical component summary improvement was independently associated with a low initial physical component summary (P <.001), high satiety (P = .002), a high percentage of excess weight loss (P = .013), and a high self-perceived effect of the LAGB (P = .026). Greater mental component summary improvement was associated with a low initial mental component summary (P <.001), high satiety (P <.001), a low frequency of heartburn (P = .004), and a high percentage of excess weight loss (P = .012). CONCLUSIONS Significant improvements in HRQOL were observed in the first year after LAGB. A poor baseline HRQOL, a high efficacy of the banding in eating control, and better weight loss might influence HRQOL changes.

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.

Three years durability of the improvements in health-related quality of life observed after gastric banding

BACKGROUND Improvements in health-related quality of life (HR-QoL) occur after bariatric surgery. However, sustainability of these changes over time remains debated. METHODS Data collected in a prospective 3-year multicenter Italian study on changes of HR-QoL after laparoscopic adjustable gastric banding were used. HR-QoL has investigated with the SF-36 questionnaire. Hunger, satiety, and the self-perceived effects of LAGB were recorded. RESULTS A total of 230 patients (53 male and 177 female) were analyzed. Body mass index was 41.4±5.4 kg/m2 at baseline, declined to 33.8±5.8 kg/m2 12 months after surgery (P<.001), and further reduced to 31.9±5.1 kg/m2 36 months after surgery (P<.001 versus 12 months). Scores in the SF-36 subscales were lower than in the general Italian population at baseline. The physical component summary score was 51.9±11.6 at baseline, improved to 79.2±15.4 at 12 months (P<.001), and stabilized to 79.8±15.6 at 36 months. The mental summary score was 52.3±11.8 at baseline, improved to 75.2±17.3 at 12 months (P<.001), and stabilized to 74.2±17.5 at 36 months. A decline>10 points between 12 and 36 months in the summary scores was observed in 22.0% of the patients for PCS and in 26.8% for MCS. In a multiple linear regression analysis, deterioration in HR-QoL in the 12-36 months period was associated to the presence of better HR-QoL values at 12 months and to a more pronounced reduction of the self-perceived effect of the banding at 36 months. CONCLUSION Improvements in HR-QoL observed in the first year after surgery maintained up to the third year after gastric banding.