Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass
NCT ID: NCT00504036
Last Updated: 2011-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
314 participants
INTERVENTIONAL
2007-10-31
2011-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intra-gastric balloon
Patients will receive either an air-filled or water-filled intra-gastric balloon.
inflatable intra-gastric balloon
inflatable intra-gastric balloon
Usual care
Usual care will be given to the patients.
No interventions assigned to this group
Interventions
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inflatable intra-gastric balloon
inflatable intra-gastric balloon
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Benoit Coffin, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hopital Louis Mourier
Colombes, , France
Countries
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References
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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;2007(1):CD004931. doi: 10.1002/14651858.CD004931.pub2.
Other Identifiers
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P060408
Identifier Type: -
Identifier Source: org_study_id