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)
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|ClinicalTrials.gov Identifier: NCT01700738|
Recruitment Status : Unknown
Verified October 2012 by University Hospital, Angers.
Recruitment status was: Not yet recruiting
First Posted : October 4, 2012
Last Update Posted : October 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Procedure: gastric ring surgery Other: nutritional help||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||November 2015|
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
- BMIZ-score evolution in 2 years. [ Time Frame: 2 years ]
- Evolution of quality of life scales [ Time Frame: 1, 2, 5 and 10 years ]
- Evaluation of des alimentary attitudinal troubles and psychiatrical troubles [ Time Frame: 1 year ]
- Evolution of BMIZ-score [ Time Frame: 1, 5 and 10 years ]
- Evolution of round-waist [ Time Frame: 1, 2, 5 and 10 years ]
- Evolution of bodily composition. [ Time Frame: 1, 2, 5 and 10 years ]
- Evolution of metabolic syndrome parameters. [ Time Frame: 1, 2, 5 and 10 years ]
- Evolution of respiratory parameters: polysomnography [ Time Frame: 2 years ]
- Determination of success factors of the ring. [ Time Frame: 2 years ]
- Study of tolerance of the gastric ring. [ Time Frame: 1, 2, 5 and 10 years ]
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 ClinicalTrials.gov identifier (NCT number): NCT01700738
|Contact: REGIS COUTANTfirstname.lastname@example.org|
|University Hospital of Angers|
|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|
|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|
|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|
|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|
|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|
|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|