V. Borrelli

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.

Abnormal esophageal acid exposure is common in morbidly obese patients and improves after a successful Lap-band system implantation

AbstractsBackground: The relation between gastro-esophageal reflux disease (GERD) and obesity is controversial. The laparoscopic adjustable gastric band (LAGB) procedure is effective for morbid obesity. Its indication in the presence of GERD, however, is still debated. This study aimed to investigate esophageal symptoms, motility patterns, and acid exposure in morbidly obese patients before and after LAGB placement. Method: For this study, 43 consecutive obese patients were investigated by a standardized symptoms questionnaire, stationary manometry and 24-h ambulatory pH-metry, and 16 patients with abnormal esophageal acid exposure were reevaluated 18 months after LAGB placement. Results: Symptom scores and abnormal esophageal acid exposure were found to be significantly higher, Lower Esophageal Sphincter (LOS) pressure was significantly lower in obese patients than in control subjects. After LAGB, esophageal acid exposure was significantly reduced in all but two patients, who presented with proximal of gastric pouch dilation. Conclusions: There is a high prevalence of GERD in the obese population. Uncomplicated LAGB placement reduces the amount of acid in these patients with abnormal esophageal acid exposure.

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.

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.

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/m2, 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 Fishers 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/m2 and 32.1±16.6%, respectively. At the same time, mean BMI was 47.6±6.9 and 48.1±6.5 kg/m2 in group A and B (P=NS). At 12 months follow-up (100%), mean BMI was 35.1 kg/m2 in Group A (BIB + surgery) and 51.7 kg/m2 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.

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.

Conversion of Lap-Band® to Gastric Bypass for Dilated Gastric Pouch

An 18-year-old female who had undergone a laparoscopic adjustable gastic banding developed several episodes of gastric pouch dilatation (GPD), treated conservatively. The last GPD (31 months after LapBand® placement) involved the lesser curvature of the stomach and was refractory to medical treatment. Conversion to an open gastric bypass was performed. Gastric bypass is an option in the case of Lap-Band® failure.

Determinants of health-related quality of life in morbid obese candidates to gastric banding

OBJECTIVE: To analyse determinants of self reported health-related quality of life (HR-QoL) in morbid obese patients candidates to laparoscopic adjustable gastric banding (LAGB). METHODS: Determinants of HR-QoL were investigated in 383 morbid obese patients (82 M and 301 F) with BMI=40 kg/m2 (BMI=35 kg/m2 if complicated obesity) and age 18–60 years. HR-QoL was determined with the SF-36 questionnaire. Determinants of the two summary measures of SF-36 (physical component and mental component) were analysed by stepwise multiple linear regression analysis with age, BMI, physical comorbidites, mental comorbidites and eating behaviour disorders as independent variables. Physical comorbities (diabetes, hypertension, hypertriglyceridemia, low HDL, sleep apnea and osteoarthritis) were coded as present or absent on the basis of simple diagnostic clinical criteria; mental comorbidities (depression) and eating behaviour disorders (binge eating, sweet eating and nibbling) on the basis of an unstructured clinical interview. RESULTS: Mean age was 38.8±10.2 years and mean BMI was 41.5±5.4 kg/m2. Scores in the eight SF-36 subscales were lower in women than in men and lower than in the general Italian population. However, 18.4–43.5% of the participants had HR-QoL levels above the normative values, depending on the scale. In both genders, low scores in the mental component of the SF-36 were associated to the presence of depression and eating behaviour disorders and not to physical comorbidities or BMI levels. Low physical self-perceived well being was associated to high BMI levels in men and to depression, hypertension and hypertriglyceridemia in women. CONCLUSION: HR-QoL was poor in morbid obese candidates to LAGB, particularly in women, and was negatively affected more by mental comorbidites and eating behaviour disorders than by physical comorbidities or BMI levels.