- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00504036
Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass (BIGPOM)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Colombes, France, 92700
- Hôpital Louis Mourier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intra-gastric balloon
Patients will receive either an air-filled or water-filled intra-gastric balloon.
|
inflatable intra-gastric balloon
|
No Intervention: Usual care
Usual care will be given to the patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of admission in Intensive Care Units
Time Frame: > 24 hrs during the 30-day period following gastric by-pass
|
> 24 hrs during the 30-day period following gastric by-pass
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences in absolute weight loss
Time Frame: at 6 months, before gastric by-pass, between the 2 strategies
|
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
|
during the 30-day post-operative period
|
Number of comorbidities present
Time Frame: after the 6-month initial period
|
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
|
at the end of first 6-month period and at the end of the study
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Differences in time of surgery, length of stay, readmission
Time Frame: during the 30-day post by-pass period
|
during the 30-day post by-pass period
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Differences in medical costs between the 2 strategies
Time Frame: 6 months before and after gastric by-pass
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6 months before and after gastric by-pass
|
Collaborators and Investigators
Investigators
- Principal Investigator: Benoit Coffin, PU-PH, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P060408
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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