Morbid Obesity Clinical Trial
Official title:
Medico Economic Evaluation of a Temporary (6 Months) Intra-gastric Balloon in Morbidly Obese Patients Before a Gastric By-pass. A Randomised Multicenter Study Comparing the Usual Strategy to Two Types of Gastric Balloon
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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