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Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass (BIGPOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00504036
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : November 1, 2011
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Morbid Obesity Device: inflatable intra-gastric balloon Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
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

No Intervention: Usual care
Usual care will be given to the patients.

Primary Outcome Measures :
  1. Rate of admission in Intensive Care Units [ Time Frame: > 24 hrs during the 30-day period following gastric by-pass ]

Secondary Outcome Measures :
  1. Differences in absolute weight loss [ Time Frame: at 6 months, before gastric by-pass, between the 2 strategies ]
  2. Number and types of complications occurring [ Time Frame: during the 30-day post-operative period ]
  3. Number of comorbidities present [ Time Frame: after the 6-month initial period ]
  4. Differences in quality of life [ Time Frame: at the end of first 6-month period and at the end of the study ]
  5. Differences in time of surgery, length of stay, readmission [ Time Frame: during the 30-day post by-pass period ]
  6. Differences in medical costs between the 2 strategies [ Time Frame: 6 months before and after gastric by-pass ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00504036

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Hopital Louis Mourier
Colombes, France, 92700
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Benoit Coffin, PU-PH Assistance Publique - Hôpitaux de Paris
Publications of Results:
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00504036    
Other Study ID Numbers: P060408
First Posted: July 19, 2007    Key Record Dates
Last Update Posted: November 1, 2011
Last Verified: October 2008
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Morbid obesity
Gastric balloon
Gastric by-pass
Morbid obesity with BMI > 45 kg/m²
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms