Obesity
Conditions
Brief summary
MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with conventional treatment of obesity. SECONDARY OBJECTIVES * 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. INCLUSION CRITERIA 1. 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 2. Obesity common non-syndromic. 3. Medical decision of surgical placement of laparoscopic gastric banding. 4. Adolescent and family who understand and accept the need for medical and surgical follow long term. 5. Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up. 6. Obtention of oral and written consent of the adolescent and the parents. 7. Parents and adolescents affiliated with the social security system. NONINCLUSION CRITERIA 1. Intellectual Deficit. 2. psychiatrics contraindication of surgical placement of laparoscopic gastric banding. 3. Obesity with severe binge eating. 4. Pregnancy or wishes of pregnancy in the following year. 5. Non accession adolescent and / or family in the process of medical care before inclusion. 6. Predictable post surgical monitoring difficulties. 7. Suspicion of physical abuse, verbal or negligence / deficiency in care of the family. 8. Participation in a clinical study evaluating a treatment during the 2 years of the study. EXCLUSION CRITERIA 1. Anesthetic contre indication for placement of a gastric laparoscopic. 2. 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.
Interventions
PROCEDUREgastric ring surgery
OTHERnutritional help
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Obesity common non-syndromic. 3. Medical decision of surgical placement of laparoscopic gastric banding. 4. Adolescent and family who understand and accept the need for medical and surgical follow long term. 5. Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up. 6. Obtention of oral and written consent of the adolescent and the parents. 7. Parents and adolescents affiliated with the social security system.
Exclusion criteria
1. Intellectual Deficit. 2. psychiatrics contraindication of surgical placement of laparoscopic gastric banding. 3. Obesity with severe binge eating. 4. Pregnancy or wishes of pregnancy in the following year. 5. Non accession adolescent and / or family in the process of medical care before inclusion. 6. Predictable post surgical monitoring difficulties. 7. Suspicion of physical abuse, verbal or negligence / deficiency in care of the family. 8. Participation in a clinical study evaluating a treatment during the 2 years of the study. 9. Anesthetic contre indication for placement of a gastric laparoscopic. 10. IMC\> 50 kg/m2 the day of inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMIZ-score evolution in 2 years. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of des alimentary attitudinal troubles and psychiatrical troubles | 1 year |
| Evolution of BMIZ-score | 1, 5 and 10 years |
| Evolution of round-waist | 1, 2, 5 and 10 years |
| Evolution of bodily composition. | 1, 2, 5 and 10 years |
| Evolution of quality of life scales | 1, 2, 5 and 10 years |
| Evolution of respiratory parameters: polysomnography | 2 years |
| Determination of success factors of the ring. | 2 years |
| Study of tolerance of the gastric ring. | 1, 2, 5 and 10 years |
| Evolution of metabolic syndrome parameters. | 1, 2, 5 and 10 years |
Countries
France
Contacts
Primary ContactREGIS COUTANT
Outcome results
None listed