To demonstrate, during a prospective randomized medico-economic study, in morbidly obese patients (BMI \> 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and peri-operative morbidity.
On inclusion, comorbidities associated with obesity will be recorded. After recording of the informed consent patients will be randomized in two groups: usual care or intra-gastric balloon. In the latter, a second randomization will be performed between air-filled balloon or water-filled balloon. Six months later, after withdrawal of the balloon (if required), laparoscopic gastric by-pass will be performed. Thereafter, patients will be followed during 6 months. On each visit, inclusion, 3 months, 6 months, surgery, 1 month and 6 months post surgery, a medical and biological evaluation will be systematically performed. The main criteria of judgement is the rate of admission in ICU during more than 24 hrs during the 30 days following surgery. The secondary criteria of judgement is: the differences in pre-operative weight loss between the 2 groups, number of complications occurring during the 30 days after surgery, differences in different scales of quality of life (SF36, IWQOL-lite), differences in operative time, length of hospital stay, readmissions, and medical cots between the two strategies. Efficacy and tolerance of each type of balloon (air-filled or water-filled) will be compared in the intra-gastric balloon group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
314
inflatable intra-gastric balloon
Hopital Louis Mourier
Colombes, France
Rate of admission in Intensive Care Units
Time frame: > 24 hrs during the 30-day period following gastric by-pass
Differences in absolute weight loss
Time frame: at 6 months, before gastric by-pass, between the 2 strategies
Number and types of complications occurring
Time frame: during the 30-day post-operative period
Number of comorbidities present
Time frame: after the 6-month initial period
Differences in quality of life
Time frame: at the end of first 6-month period and at the end of the study
Differences in time of surgery, length of stay, readmission
Time frame: during the 30-day post by-pass period
Differences in medical costs between the 2 strategies
Time frame: 6 months before and after gastric by-pass
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