An interventional study of inflatable intra-gastric balloon in Morbid Obesity, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-11-01.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 314 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Patients will receive either an air-filled or water-filled intra-gastric balloon.
Device: inflatable intra-gastric balloon
Usual care will be given to the patients.
inflatable intra-gastric balloon
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
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris