Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504036
Status:
COMPLETED
Last Update Posted:
2011-11-01
First Post:
2007-07-18
Brief Title:
Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIGPOM
Brief Summary:
To demonstrate during a prospective randomized medico-economic study in morbidly obese patients BMI 45 kgm² 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None