title: BioEnterics intragastric balloon for treatment of morbid obesity in Prader-Willi syndrome: specific risks and benefits.
abstract: BACKGROUND
  Obesity in Prader-Willi Syndrome (PWS) is progressive, severe, and resistant to dietary, pharmacological, and behavioral treatment. A body weight reduction is mandatory to reduce the risk of cardio-respiratory and metabolic complications. The aim of the study was to assess risks and benefits of BioEnterics Intragastric Balloon (BIB) for treatment of morbid obesity in PWS patients.
  
  
  METHODS
  Twenty-one BIB were positioned in 12 PWS patients (4 M, 8 F), aged from 8.1 to 30.1 years, and removed after 8 +/- 1.4 months (range: 5-10 months). Auxological, clinical, and nutritional evaluations were performed every 2 months. Variations in body composition were analysed by dual energy X-ray absorbiometry (DXA).
  
  
  RESULTS
  One patient (28.5 years, BMI: 59.3 kg/m(2)) died 22 days after BIB positioning because of gastric perforation. In another case (26.2 years, BMI: 57.6 kg/m(2)), BIB was surgically removed after 25 days because of symptoms suggesting gastric perforation (not confirmed). The remaining ten patients showed a significant decrease of BMI (p = 0.005) and of fat tissue as measured by DXA (p = 0.012). No significant modifications in bone mineral density (BMD) occurred, but a slight loss in lean body mass (p = 0.036) was documented. In five patients, BIB treatment was repeated more than once.
  
  
  CONCLUSIONS
  This study shows that when noninvasive pharmacological therapies fail, BIB may be effective to control body weight in PWS patients with morbid obesity, particularly when treatment is started in early childhood. However, careful clinical follow-up and close collaboration with parents are crucial to avoid severe complications, which can be caused by persisting unrestrained food intake.
authors.affiliation: Paediatric Surgery Unit, Bambino Gesù Children's Hospital-Research Institute, Palidoro (Roma), Italy.
authors.forename: F
authors.initials: F
authors.lastname: De Peppo
authors.forename: G
authors.initials: G
authors.lastname: Di Giorgio
authors.forename: M
authors.initials: M
authors.lastname: Germani
authors.forename: E
authors.initials: E
authors.lastname: Ceriati
authors.forename: P
authors.initials: P
authors.lastname: Marchetti
authors.forename: C
authors.initials: C
authors.lastname: Galli
authors.forename: M G
authors.initials: MG
authors.lastname: Ubertini
authors.forename: S
authors.initials: S
authors.lastname: Spera
authors.forename: G
authors.initials: G
authors.lastname: Ferrante
authors.forename: M
authors.initials: M
authors.lastname: Cuttini
authors.forename: M
authors.initials: M
authors.lastname: Cappa
authors.forename: G
authors.initials: G
authors.lastname: Castelli Gattinara
authors.forename: M
authors.initials: M
authors.lastname: Rivosecchi
authors.forename: A
authors.initials: A
authors.lastname: Crinò
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D015897:Comorbidity; D016099:Endoscopy, Gastrointestinal; D005260:Female; D015905:Gastric Balloon / Q000009:adverse effects; D006801:Humans; D008297:Male; D009767:Obesity, Morbid / Q000453:epidemiology* / Q000628:therapy*; D011182:Postoperative Care; D011218:Prader-Willi Syndrome / Q000453:epidemiology*; D019919:Prosthesis Implantation / Q000379:methods; D018570:Risk Assessment; D015431:Weight Loss; D055815:Young Adult