Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric by-Pass (BIGPOM)
This study is not yet open for patient recruitment.
Verified by Assistance Publique - Hôpitaux de Paris June 2007
| Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
| Information provided by: |
Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: |
NCT00504036 |
|
Purpose
To demonstrate, during a prospective randomised 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
|
MedlinePlus
related topics:
Obesity
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Number of arms in study: 2
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
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
-
Rate of admission in Intensive Care Units [Time Frame: > 24 hrs during the 30-day period following gastric by-pass]
Secondary Outcome Measures:
-
Differences in absolute weight loss [Time Frame: 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]
-
Number of comorbidities present [Time Frame: 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]
-
Differences in time of surgery, length of stay, readmission [Time Frame: during the 30-day post by-pass period]
-
Differences in medical costs between the 2 strategies [Time Frame: 6 months before and after gastric by-pass]
Total Enrollment: 314
Study start: September 2007; Expected completion: March 2010
| Arms |
Assigned Interventions |
- 2:
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
|
- Device: inflatable intra-gastric balloon
inflatable intra-gastric balloon
|
On inclusion, comorbidities associated with obesity will be recorded. After recording of the informed consent patients will be randomised in two groups : usual care or intra-gastric balloon. In this later, a second randomisation will be performed between air filled balloon or water filled balloon. 6 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 - 75 Years, Genders Eligible for Study: Both
Criteria
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 non taking PPI
-
Patients with bulimia
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00504036
France
Hopital Louis Mourier, COLOMBES, 92700, France
Study chairs or principal investigators
Benoit COFFIN, PU-PH, Principal Investigator, Assistance Publique - Hôpitaux de Paris
More Information
Publications that report results of this study
Fernandes M, Atallah AN, Soares BG, Humberto S, Guimaraes S, Matos D, Monteiro L, Richter B. Intragastric balloon for obesity. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD004931. Review.
