title: Adjustable intragastric balloon vs non-adjustable intragastric balloon: case-control study on complications, tolerance, and efficacy.
abstract: BACKGROUND
  The objective of this study is the comparison of a new intragastric balloon recently introduced, the Adjustable Balloon System (ABS), with the BioEnterics intragastric balloon (BIB) in terms of tolerance, safety, and weight loss parameters.
  
  
  METHODS
  A case-control study was done: 40 patients were matched with 80 controls. To achieve the same duration therapy (12 months), a single ABS positioning was compared with a BIB followed by another BIB (6 + 6 months). Length of procedure, hospital stay, complications, and weight loss parameters after 6 months (time of first BIB removal) and after 12 months from baseline (time of Spatz and second BIB removal) were considered. Statistical analysis was done by means of Student's t test, χ2 test, or Fisher's test. P < 0.05 was considered significant.
  
  
  RESULTS
  Mortality, positioning, and extraction complications were absent. Both the devices were well tolerated with slight duration of post placement symptoms. During this study, the Spatz balloon was adjusted with inflation of 200 cm(3) of saline (total, 800 cm(3)) in 9/40 (22.5 %) patients, for poor weight loss after first 6-months treatment. In the Spatz group, there occurred 7/40 complications linked to the device and in 6/7 patients the balloon was removed. At the end of the study, the weight loss parameters were similar between groups: BMI 31.0 ± 11.8 (Spatz group) vs 31.3 ± 12.3 (BIB group) (p = Ns).
  
  
  CONCLUSIONS
  The idea of dynamic balloon therapy needs to be confirmed with wider series. The rate of complication reported is very high, and several studies regarding safety and efficacy are needed.
authors.affiliation: Paride Stefanini Department, La Sapienza University, Rome, Italy.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Genco
authors.forename: Daniela
authors.initials: D
authors.lastname: Dellepiane
authors.forename: Giovanni
authors.initials: G
authors.lastname: Baglio
authors.forename: Fulvio
authors.initials: F
authors.lastname: Cappelletti
authors.forename: Francesca
authors.initials: F
authors.lastname: Frangella
authors.forename: Roberta
authors.initials: R
authors.lastname: Maselli
authors.forename: Maria Chiara
authors.initials: MC
authors.lastname: Dante
authors.forename: Romina
authors.initials: R
authors.lastname: Camoirano
authors.forename: Michele
authors.initials: M
authors.lastname: Lorenzo
authors.forename: Nicola
authors.initials: N
authors.lastname: Basso
mesh_terms: D000293:Adolescent; D000328:Adult; D015992:Body Mass Index; D016022:Case-Control Studies; D020878:Device Removal; D004867:Equipment Design; D005260:Female; D015905:Gastric Balloon / Q000009:adverse effects; D006801:Humans; D007558:Italy / Q000453:epidemiology; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000453:epidemiology / Q000601:surgery*; D061646:Operative Time; D018579:Patient Selection; D020250:Postoperative Nausea and Vomiting / Q000453:epidemiology / Q000601:surgery*; D016896:Treatment Outcome; D015431:Weight Loss