Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass (BIGPOM)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Rate of admission in Intensive Care Units [ Time Frame: > 24 hrs during the 30-day period following gastric by-pass ] [ Designated as safety issue: Yes ]
- Differences in absolute weight loss [ Time Frame: at 6 months, before gastric by-pass, between the 2 strategies ] [ Designated as safety issue: Yes ]
- Number and types of complications occurring [ Time Frame: during the 30-day post-operative period ] [ Designated as safety issue: Yes ]
- Number of comorbidities present [ Time Frame: after the 6-month initial period ] [ Designated as safety issue: No ]
- Differences in quality of life [ Time Frame: at the end of first 6-month period and at the end of the study ] [ Designated as safety issue: Yes ]
- Differences in time of surgery, length of stay, readmission [ Time Frame: during the 30-day post by-pass period ] [ Designated as safety issue: Yes ]
- Differences in medical costs between the 2 strategies [ Time Frame: 6 months before and after gastric by-pass ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Intra-gastric balloon
Patients will receive either an air-filled or water-filled intra-gastric balloon.
Device: inflatable intra-gastric balloon
inflatable intra-gastric balloon
Other Name: inflatable intra-gastric balloon
No Intervention: Usual care
Usual care will be given to the patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504036
|Hopital Louis Mourier|
|Colombes, France, 92700|
|Principal Investigator:||Benoit Coffin, PU-PH||Assistance Publique - Hôpitaux de Paris|