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
|Contact: REGIS COUTANTemail@example.com|
|University Hospital of Angers||Not yet recruiting|
|Angers, France, 49000|
|Principal Investigator: REGIS COUTANT|
|Sub-Investigator: FRANCOISE SCHMITT|
|Principal Investigator: GUILLAUME PODEVIN|
|Sub-Investigator: JEAN-LOUIS GINIES|
|Sub-Investigator: AGNES SALLE|
|University Hospital of Caen||Not yet recruiting|
|Caen, France, 14033|
|Contact: DOMINIQUE BOUGLE 0231515161|
|Principal Investigator: DOMINIQUE BOUGLE|
|Sub-Investigator: JULIEN ROD|
|Sub-Investigator: MURIEL LAURANS|
|Principal Investigator: YANNICK LE ROUX|
|Sub-Investigator: MARIE-ASTRID PIQUET|
|University hospital Bicêtre||Not yet recruiting|
|Le Kremlin Bicetre, France, 94275|
|Contact: PIERRE BOUGNIERES 0145217832|
|Principal Investigator: PIERRE BOUGNIERE|
|Sub-Investigator: GIANPAOLO DE FILIPPO|
|Sub-Investigator: CATHERINE PIQUARD|
|University Hospital of Lille||Not yet recruiting|
|Lille, France, 59037|
|Contact: IVA GUEORGUIEVA 0320446885|
|Principal Investigator: IVA GUEORGUIEVA|
|Sub-Investigator: JACQUES WEILL|
|Principal Investigator: ESTELLE AUBRY|
|Sub-Investigator: FRANCOIS PATTOU|
|Sub-Investigator: MARIE PIGEYRE|
|University Hospital of Necker||Not yet recruiting|
|Paris, France, 75743|
|Contact: OLIVIER GOULET 0144492501|
|Principal Investigator: OLIVIER GOULET|
|Sub-Investigator: MYRIAM TYAN-DABBAS|
|Principal Investigator: NAZIHA KHEN-DUNLOP|
|University Hospital of Toulouse||Not yet recruiting|
|Toulouse, France, 31059|
|Contact: MAITHE TAUBER 0534558555|
|Principal Investigator: MAITHE TAUBER|
|Sub-Investigator: GWENAELLE DIENE|
|Sub-Investigator: BEATRICE JOURET|
|Sub-Investigator: PATRICK RITZ|
|Principal Investigator:||REGIS COUTANT||UNIVERSITY HOSPITAL OF ANGERS|