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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00504036 |
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.
Condition | Intervention |
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Morbid Obesity |
Device: inflatable intra-gastric balloon |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 314 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Intra-gastric balloon: Experimental
Patients will receive either an air-filled or water-filled intra-gastric balloon.
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Device: inflatable intra-gastric balloon
inflatable intra-gastric balloon
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Usual care: No Intervention
Usual care will be given to the patients.
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Benoit Coffin, PU-PH | +33(0)1 47 60 60 61 | benoit.coffin@lmr.aphp.fr |
France | |
Hopital Louis Mourier | Recruiting |
Colombes, France, 92700 | |
Contact: Benoit Coffin, PU-PH +33(0)1 47 60 60 61 benoit.coffin@lmr.aphp.fr |
Principal Investigator: | Benoit Coffin, PU-PH | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Magali LAFAYE ) |
Study ID Numbers: | P060408 |
Study First Received: | July 18, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00504036 |
Health Authority: | France: Ministry of Health |
Obesity Morbid obesity Gastric balloon Gastric by-pass Morbid obesity with BMI > 45 kg/m² |
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Obesity, Morbid |