title: Intragastric balloon for obesity treatment: results of a multicentric evaluation for balloons left in place for more than 6 months.
abstract: BACKGROUND
  Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months.
  
  
  METHODS
  A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected.
  
  
  RESULTS
  Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded.
  
  
  CONCLUSIONS
  Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.
authors.affiliation: Laparoscopic Surgical Department, "Umberto I°" General Hospital, Medical School "Sapienza" University, Rome, Italy, alfredo.genco@uniroma1.it.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Genco
authors.forename: Roberta
authors.initials: R
authors.lastname: Maselli
authors.forename: Francesca
authors.initials: F
authors.lastname: Frangella
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Cipriano
authors.forename: Pietro
authors.initials: P
authors.lastname: Forestieri
authors.forename: Daniela
authors.initials: D
authors.lastname: Delle Piane
authors.forename: Francesco
authors.initials: F
authors.lastname: Furbetta
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Micheletto
authors.forename: Franco
authors.initials: F
authors.lastname: Ciampaglia
authors.forename: Paola
authors.initials: P
authors.lastname: Granelli
authors.forename: Maurizio
authors.initials: M
authors.lastname: Zilli
authors.forename: Michele
authors.initials: M
authors.lastname: Lorenzo
authors.forename: Giorgio
authors.initials: G
authors.lastname: Di Rocco
authors.forename: Domenico
authors.initials: D
authors.lastname: Giannotti
authors.forename: Adriano
authors.initials: A
authors.lastname: Redler
mesh_terms: D000328:Adult; D015992:Body Mass Index; D015331:Cohort Studies; D020878:Device Removal / Q000379:methods; D005260:Female; D015905:Gastric Balloon; D006801:Humans; D007558:Italy; D008297:Male; D009767:Obesity, Morbid / Q000601:surgery*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D015431:Weight Loss