Santo Bressani Doldi

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.

Treatment of morbid obesity with Intragastric balloon in association with diet

Background: The BioEnterics Intragastric Balloon (BIB®, BioEnterics, Santa Barbara, CA) in association with restricted diet has been used for the treatment of obesity and morbid obesity. Methods: Since March 1998, 322 BIB were placed in 281 obese and morbidly obese patients; 73 patients were male and 208 female; mean age was 41.6 years (21-70); mean weight was 117.4 kg (67- 229); mean BMI was 41.8 kg/m2 (29-81); % excess weight was 62% (10-216). The balloon was inserted and removed endoscopically under general anesthesia. Patients were given a balanced diet of 1000 kcal/day.Also, for 18 months we compared 42 obese patients treated only with 1000 kcal/day diet (group A) with 31 obese patients subjected to BIB for 4 months + 1000 kcal/day diet (group B). Results: After 4 months of balloon treatment, the mean weight loss was 13.9 kg and the mean reduction in BMI was 4.8. Weight loss was greater in male patients. Weight loss was accompanied by an improvement of the diseases associated with obesity, in particular diabetes. In the diet vs BIB+diet study, BIB with diet produced a greater weight loss in a shorter time than diet alone. Conclusion: The best indications for BIB were: morbidly obese opatients (BMI>40) and super-obese patients (BMI>50) in preparation for bariatric operations; obese patients with BMI 35-40 with co-morbilities in preparation for bariatric surgery; obese patients with BMI 30-35 with a chronic disease otherwise unresolved; patients with BMI <30 only in a multidisciplinary approach.

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.

Adjustable Gastric Banding: 5-Year Experience

Background: From 1993 to 1999, 172 patients underwent adjustable silicone gastric banding (ASGB) or laparoscopic adjustable silicone gastric banding (LASGB). In 109 patients the adjustable band was placed via laparoscopy; in the other patients it was placed via laparotomy (prelaparoscopic era, conversions from other bariatric operations, conversions for laparoscopic failure). The conversion rate from laparoscopy to laparotomy was 9.3%, occurring in the early part of our experience. Methods: Mean age was 37.9 years, weight 135 ± 14.8 kg (82-218) and BMI 46.3 ± 5.4 (35.1-69.5). All patients had multiple band adjustments, temporary antisecretive, electrolyte and vitamin therapy, and follow-up per routine. Results: Weight loss at 3 years was 30.2%; mean percent loss of excess weight was 62.5%.There was no mortality.The most important technical complications were: gastric pouch dilatation that required band replacement or removal (5.8 %); mild gastric pouch dilatation reversible with adequate dietary and pharmacological treatment (4.6%); intraoperative gastric perforation (2.3%); band migration (0.6%).The band was removed in 2.3%, with conversion to another bariatric procedure in 1.1%. Conclusions: Results have been satisfactory thus far.

Intragastric balloon in obese patients.

Background: Since March 1998, 143 BioEnterics® Intragastric Balloons (BIB) were placed in 132 obese and morbidly obese patients, to study the clinical possibilities of a new system, both from the point of view of the materials used and the application method. Methods: 36 patients were male and 96 female; mean age was 43 years (21-70); mean weight was 115.4 kg (67-229), and mean BMI was 41.0 (29-81). 8 patients were affected by severe respiratory insufficiency. We placed and removed the balloon endoscopically under conscious sedation or general anesthesia. BIB was removed in the majority of patients 4 months after insertion. The patients were given a balanced diet of 800-1000 kcal/day; follow-up involved a monthly check-up (routine blood tests, weight control) and a visit every 15 days with the dietitian. Results: Mean weight loss was 14.4 kg; mean reduction in BMI was 5.2.Weight loss was much better in males. The weight loss produced an improvement of the complications associated with the obesity. Complications observed were: balloon intolerance (9 early removals), 1 balloon deflated and passed, 2 cases of gastric ulcer at balloon removal. Conclusions:The most correct indications for BIB should be: extremely obese patients (BMI>40) in preparation for a bariatric operation; obese patients with BMI 30-35 with a chronic disease otherwise unresolved; patients with BMI< 30 in a multidisciplinary approach.

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.

Prevention of Pouch Dilatation after Laparoscopic Adjustable Gastric Banding

Background: The major long-term complication of laparoscopic adjustable gastric banding (LAGB) is dilatation of the gastric pouch, that is reported with a frequency ranging from 1 to 25%, and often requires removal of the band. In addition to the usual recommendations of bariatric surgery centers and dietetic advice to prevent this complication, over the last 4 years we introduced a technical modification of the procedure. Methods: From Nov 1993 to Dec 2004, 684 morbidly obese patients underwent adjustable gastric banding, 83 patients by open surgery and 601 patients by laparoscopy. The first 323 patients (group A) were operated by the perigastric approach, and 57 patients (group B) were operated by the pars flaccida approach. Since Dec 2000, 304 patients (group C) were operated with a modified pars flaccida technique, which consisted in suturing the gastric lesser curvature below the band with one or two stitches to the right phrenic crus to secure the band in place. Results: In group A, the most important late complication was irreversible dilatation of the gastric pouch, which occurred in 35 patients (10.8%), and required removal of the band in 30 cases and replacement in 5. In group B, there were 3 pouch dilatations (5.2%). In group C, only 4 dilatations occurred (1.31%), which required 3 band removals and 1 band replacement. Conclusion: Dilatation of the gastric pouch appears to be dramatically reduced by our minor technical modification of band placement.

Effect of Bile Salts on Carbonic Anhydrase from Rat and Human Gastric Mucosa

Gastric carbonic anhydrase (CA) is believed to play an important role related to cytoprotection, and duodenogastric reflux of bile salts (BS) is suspected of having a causal role in many pathologic conditions. Thus, we decided to investigate the effect of free and conjugated BS on human and rat gastric CA activity. Cholate exerted the most potent inhibitory activity on both human (I50 = 2.24 mM) and rat (I50 = 1.68 mM) gastric CA, followed by glycochenodeoxycholate and taurocholate (I50 = 6.90 mM and 13.67 mM on rat gastric CA). Human and rat whole bile produced 10-90% and 20-40% inhibition of gastric CA of the same species. Since the concentrations of free and conjugated BS tested in this study can be found in the postgastrectomized stomach, our data suggest that inhibition of gastric CA might be one mechanism contributing to the gastric mucosa damage caused by BS refluxing into the stomach after gastric surgery.