Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass (BIGPOM)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Morbid Obesity

Treatments

Device: inflatable intra-gastric balloon

Study type

Interventional

Funder types

Other

Identifiers

NCT00504036

P060408

Details and patient eligibility

About

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.

Full description

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.

Enrollment

314 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 75 years
Patients with morbid obesity with BMI > 45 kg/m² requiring a gastric by-pass by laparoscopy.
No efficacy of previous treatment on obesity
Firmed informed consent

Exclusion criteria

Patients in whom laparoscopy is contra-indicated
Indication of gastric by-pass by laparoscopy retained without multidisciplinary advice
Morbid obesity present since less than 5 years
Severe associated pathology, non-related to obesity, impairing vital prognosis on a short or mean time
Past history of gastric surgery, or gastric complication related to gastric lap-band
Lack of health insurance
Patient refusing to be followed 6 months before and after surgery
Drug abuse
Pregnancy or foreseeable pregnancy during the study
Patients taking anticoagulant agents or steroids
Patients with hiatal hernia > 4 cm
Patients with active ulcerated esophagitis (grade C-D in Los Angeles Classification)
Patients with duodenal or gastric ulcer
Patients with gastric or esophageal varices
Patients with NSAIDs not taking PPI
Patients with bulimia