title: Analysis of safety and efficacy of intragastric balloon in extremely obese patients.
abstract: BACKGROUND
  The implantation of an intragastric balloon constitutes a short-term effective non-surgical intervention to lose weight. The aim of this study was to evaluate retrospectively the clinical outcome and safety of gastric balloon therapy (GBT) in extremely obese patients.
  
  
  METHODS
  One hundred and nine super- and super-super-obese patients, 64 males and 45 females, mean age 39.1+/-8.4 years, mean body mass index (BMI) 68.8+/-8.9 kg/m2, who underwent GBT for weight loss, were studied retrospectively. GBT was assessed in massively obese patients concerning tolerance, weight loss, number of comorbidities and complications.
  
  
  RESULTS
  A significant reduction in patients' weight and BMI was evident after GBT. Regarding safety, no major complications occurred. Minor complications at balloon placement and removal occurred in one (0.9%) and three patients (2.8%) respectively. Mean duration of GBT was 177.6+/-56.8 days. After GBT, the mean weight loss was 26.3+/-15.2 kg (p<0.001) and the mean BMI reduction was 8.7+/-5.1 kg/m2 (p<0.001) representing a mean percentage of excess BMI lost (%EBL) of 19.7+/-10.2. The highest BMI loss was observed in patients with BMI>80 kg/m2. A noteworthy improvement of comorbidities in 56.8% of the patients was also noted. Of the 109 patients, 69 received subsequent bariatric surgery. All the procedures were performed laparoscopically. Ten patients, with a mean BMI of 68.6+/-10.6 kg/m2 after the removal of the first BIB, received a second BIB resulting in a non-significant weight and BMI loss of 6.3+/-9.4 kg and 1.8+/-2.9 kg/m2, respectively.
  
  
  CONCLUSIONS
  Our study indicates the safety and efficacy of GBT in extremely obese patients particularly as a first step before a definitive anti-obesity operation. GBT appears to be a safe, tolerable, and potentially effective procedure for the initial treatment of morbid obesity.
authors.affiliation: Department of General and Bariatric Surgery, Center for Minimal-Invasive Surgery, Krankenhaus Sachsenhausen, Frankfurt am Main, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Göttig
authors.forename: Markos
authors.initials: M
authors.lastname: Daskalakis
authors.forename: Sylvia
authors.initials: S
authors.lastname: Weiner
authors.forename: Rudolf A
authors.initials: RA
authors.lastname: Weiner
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D015905:Gastric Balloon / Q000009:adverse effects / Q000592:standards*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000150:complications / Q000628:therapy*; D012189:Retrospective Studies; D015431:Weight Loss; D055815:Young Adult