title: Obesity treatment using a Bioenterics intragastric balloon (BIB)--preliminary Croatian results.
abstract: OBJECTIVE
  This study aims to assess the effectiveness, tolerance, safety, and patient satisfaction of obesity treatments using the Bioenterics intragastric balloon (BIB).
  
  
  METHODS
  Prospective controlled trial of 33 obese patients who were treated with the BIB from March 2008 to March 2009 and who completed the 6 months treatment. Patients were selected on the basis of workup by a multidisciplinary team. The 33 obese patients (26 females, seven males) had a median age of 35 years (range 20-58). Their median baseline body weight (BW) was 114 kg (range 89-197) and their median body mass index (BMI) was 41.4 kg/m(2) (range 31.2-60.8).
  
  
  RESULTS
  Average weight reduction was 14 kg (range 2-37), loss total weight 10.1% (range 1.4-23.1), control BMI 35.6 kg/m(2) (range 29.4-50.3), delta BMI 4.5 (range 0.6-13.1), percentage excess weight loss 29.2 (range 2.8-53.6), and percent of excess BMI loss 29.3 (range 2.7-67.4). In one female patient the BIB was removed early due to intolerance. During the first week, minor side effects were noticed: nausea/vomiting occurred in 21 patients (63.6%), and abdominal cramps in 15 (45.5%). There was one balloon deflation and one impaction in the stomach. Those incidents were both successfully treated endoscopically. Patients had no major complications from mucosal lesions and no need for surgical interventions. All intragastric balloons were successfully removed endoscopically. Patients' treatment satisfaction correlated with the degree of BW loss (p = 0.0138).
  
  
  CONCLUSIONS
  BIB treatment in our setting showed the best results for individuals with BMI from 35 to 40 kg/m(2). Our preliminary results showed that BIB is safe, well tolerated with minor side effects, and alters quality of life for the better. The complication rate was negligible, due to the detailed pretreatment examinations and follow-up.
authors.affiliation: Department of Internal Medicine, Gastroenterology and Hepatology Division, University Hospital Sestre Milosrdnice, Zagreb, Croatia. marko.nikolic72@gmail.com
authors.forename: Marko
authors.initials: M
authors.lastname: Nikolic
authors.forename: Gorana
authors.initials: G
authors.lastname: Mirosevic
authors.forename: Neven
authors.initials: N
authors.lastname: Ljubicic
authors.forename: Marko
authors.initials: M
authors.lastname: Boban
authors.forename: Vladimir
authors.initials: V
authors.lastname: Supanc
authors.forename: Borka Pezo
authors.initials: BP
authors.lastname: Nikolic
authors.forename: Vanja
authors.initials: V
authors.lastname: Zjacic-Rotkvic
authors.forename: Miroslav
authors.initials: M
authors.lastname: Bekavac-Beslin
authors.forename: Petar
authors.initials: P
authors.lastname: Gacina
mesh_terms: D000328:Adult; D015992:Body Mass Index; D017523:Croatia; D005260:Female; D015905:Gastric Balloon / Q000009:adverse effects; D005773:Gastroscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000628:therapy*; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011446:Prospective Studies; D016896:Treatment Outcome; D015431:Weight Loss