Evaluation of the Effects of Laying Early a Gastric Band on the Prevention of Morbid Obesity Randomized Checked Against Standard Management of Obesity in This Population. (CHADO)
Recruitment status was: Not yet recruiting
MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with "conventional" treatment of obesity.
- Compare the effects of the placement of a gastric band with "conventional" treatment of obesity on quality of life, body composition and parameters of the metabolic syndrome.
- Identify predictors of "good answer to the ring" to determine the best future indications.
- Study of the gastric tolerance.
- Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is greater than IMCZ-score > 4 DP> 8 kg
- Obesity "common" non-syndromic.
- Medical decision of surgical placement of laparoscopic gastric banding.
- Adolescent and family who understand and accept the need for medical and surgical follow long term.
- Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up.
- Obtention of oral and written consent of the adolescent and the parents.
- Parents and adolescents affiliated with the social security system.
- Intellectual Deficit.
- psychiatrics contraindication of surgical placement of laparoscopic gastric banding.
- Obesity with severe binge eating.
- Pregnancy or wishes of pregnancy in the following year.
- Non accession adolescent and / or family in the process of medical care before inclusion.
- Predictable post surgical monitoring difficulties.
- Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.
- Participation in a clinical study evaluating a treatment during the 2 years of the study.
- Anesthetic contre indication for placement of a gastric laparoscopic.
- IMC> 50 kg/m2 the day of inclusion.
STRATEGIES / PROCEDURES During a routine visit, the study will be presented to the patient and his family. Patients will then be enrolled and randomized. Patients in group A (surgery group) will follow the usual multidisciplinary bariatric surgery in adolescents. Patients in group B start conventional monitoring dietary medical and physical. For both groups follow-up visits will occur every 3 months for 2 years.
Procedure: gastric ring surgery
Other: nutritional help
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Effects of Laying Early (Between 12 and 16) a Gastric Band on the Prevention of Morbid Obesity in Late Adolescence. Randomized Checked Against Standard Management of Obesity in This Population.|
- BMIZ-score evolution in 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Evolution of quality of life scales [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
- Evaluation of des alimentary attitudinal troubles and psychiatrical troubles [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Evolution of BMIZ-score [ Time Frame: 1, 5 and 10 years ] [ Designated as safety issue: No ]
- Evolution of round-waist [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
- Evolution of bodily composition. [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
- Evolution of metabolic syndrome parameters. [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: Yes ]
- Evolution of respiratory parameters: polysomnography [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Determination of success factors of the ring. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Study of tolerance of the gastric ring. [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: gastric ring surgery
in this group a gastric ring will be put by surgery.
|Procedure: gastric ring surgery|
Active Comparator: nutritional help
the usual treatment of obesity in France with nutritional care will be dispensed for this arm
|Other: nutritional help|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700738
|University Hospital of Angers|
|Angers, France, 49000|
|University Hospital of Caen|
|Caen, France, 14033|
|University hospital Bicêtre|
|Le Kremlin Bicetre, France, 94275|
|University Hospital of Lille|
|Lille, France, 59037|
|University Hospital of Necker|
|Paris, France, 75743|
|University Hospital of Toulouse|
|Toulouse, France, 31059|
|Principal Investigator:||REGIS COUTANT||UNIVERSITY HOSPITAL OF ANGERS|