Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-Pass - Full Text View

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 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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	314
Study Start Date:	September 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intra-gastric balloon: Experimental Patients will receive either an air-filled or water-filled intra-gastric balloon.	Device: inflatable intra-gastric balloon inflatable intra-gastric balloon
Usual care: No Intervention 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

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 not taking PPI
Patients with bulimia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504036

Contacts

Contact: Benoit Coffin, PU-PH

+33(0)1 47 60 60 61

benoit.coffin@lmr.aphp.fr

Locations

France
Hopital Louis Mourier	Recruiting
Colombes, France, 92700
Contact: Benoit Coffin, PU-PH +33(0)1 47 60 60 61 benoit.coffin@lmr.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Benoit Coffin, PU-PH

Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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.

Responsible Party:	Department Clinical Research of Developpement ( Magali LAFAYE )
Study ID Numbers:	P060408
Study First Received:	July 18, 2007
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00504036 History of Changes
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

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Obesity, Morbid

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on September 11, 2009