title: BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients.
abstract: BACKGROUND
  The temporary use of the BioEnterics Intragastric Balloon (BIB) in morbidly obesity is increasing worldwide. The aim of this study is the evaluation of the efficacy of this device in a large population, in terms of weight loss and its influence on co-morbidities.
  
  
  METHODS
  Data were retrospectively recruited from the data-base of the Italian Collaborative Study Group for Lap-Band and BIB (GILB). After diagnostic endoscopy, the BIB was positioned and was filled with saline (500-700 ml) and methylene blue (10 ml). Patients were discharged with diet counselling ( approximately 1000 Kcal) and medical therapy. The BIB was removed after 6 months. Positioning and removal were performed under conscious or unconscious sedation. Mortality, complications, BMI, %EWL, BMI loss and co-morbidities were evaluated.
  
  
  RESULTS
  From May 2000 to September 2004, 2,515 patients underwent BIB (722M/1,793F; mean age 38.9+/-14.7, range 12-71; mean BMI 44.4+/-7.8 kg/m(2) ; range 28.0-79.1; and mean excess weight 59.5+/-29.8 kg, range 16-210). BIB positioning was uncomplicated in all but two cases (0.08%) with acute gastric dilation treated conservatively. Overall complication rate was 70/2,515 (2.8%). Gastric perforation occurred in 5 patients (0.19%), 4 of whom had undergone previous gastric surgery: 2 died and 2 were successfully treated by laparoscopic repair after balloon removal. 19 gastric obstructions (0.76%) presented in the first week after positioning and were successfully treated by balloon removal. Balloon rupture (n=9; 0.36%) was not prevalent within any particular period of BIB treatment, and was also treated by BIB removal. Esophagitis (n=32; 1.27%) and gastric ulcer (n=5; 0.2%) presented in patients without a history of peptic disease and were treated conservatively by drugs. Preoperative co-morbidities were diagnosed in 1,394/2,471 patients (56.4%); these resolved in 617/1,394 (44.3%), improved (less pharmacological dosage or shift to other therapies) in 625/1,394 (44.8%), and were unchanged in 152/1,394 (10.9%). After 6 months, mean BMI was 35.4+/-11.8 kg/m(2) (range 24-73) and %EWL was 33.9+/-18.7 (range 0-87). BMI loss was 4.9+/-12.7 kg/m(2) (range 0-25).
  
  
  CONCLUSIONS
  BIB is an effective procedure with satisfactory weight loss and improvement in co-morbidities after 6 months. Previous gastric surgery is a contraindication to BIB placement.
authors.affiliation: Italian Group for Lap-Band, Fondazione IDIS - Città della Scienza, Naples, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Genco
authors.forename: T
authors.initials: T
authors.lastname: Bruni
authors.forename: S B
authors.initials: SB
authors.lastname: Doldi
authors.forename: P
authors.initials: P
authors.lastname: Forestieri
authors.forename: M
authors.initials: M
authors.lastname: Marino
authors.forename: L
authors.initials: L
authors.lastname: Busetto
authors.forename: C
authors.initials: C
authors.lastname: Giardiello
authors.forename: L
authors.initials: L
authors.lastname: Angrisani
authors.forename: L
authors.initials: L
authors.lastname: Pecchioli
authors.forename: P
authors.initials: P
authors.lastname: Stornelli
authors.forename: F
authors.initials: F
authors.lastname: Puglisi
authors.forename: M
authors.initials: M
authors.lastname: Alkilani
authors.forename: A
authors.initials: A
authors.lastname: Nigri
authors.forename: N
authors.initials: N
authors.lastname: Di Lorenzo
authors.forename: F
authors.initials: F
authors.lastname: Furbetta
authors.forename: A
authors.initials: A
authors.lastname: Cascardo
authors.forename: M
authors.initials: M
authors.lastname: Cipriano
authors.forename: M
authors.initials: M
authors.lastname: Lorenzo
authors.forename: N
authors.initials: N
authors.lastname: Basso
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D050110:Bariatric Surgery / Q000295:instrumentation*; D002648:Child; D015897:Comorbidity; D015905:Gastric Balloon; D006801:Humans; D007558:Italy; D008875:Middle Aged; D009767:Obesity, Morbid / Q000453:epidemiology / Q000601:surgery*; D012189:Retrospective Studies; D016896:Treatment Outcome; D015431:Weight Loss