Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass (BIGPOM)
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Purpose
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 |
|---|---|
|
Morbid Obesity |
Device: inflatable intra-gastric balloon |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 314 |
| Study Start Date: | October 2007 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Hopital Louis Mourier | |
| Colombes, France, 92700 | |
| Principal Investigator: | Benoit Coffin, PU-PH | Assistance Publique - Hôpitaux de Paris |
More Information
Publications:
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00504036 History of Changes |
| Other Study ID Numbers: | P060408 |
| Study First Received: | July 18, 2007 |
| Last Updated: | October 31, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Obesity Morbid obesity Gastric balloon Gastric by-pass Morbid obesity with BMI > 45 kg/m² |
Additional relevant MeSH terms:
|
Obesity Obesity, Morbid Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013