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MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with "conventional" treatment of obesity.
SECONDARY OBJECTIVES
INCLUSION CRITERIA
NONINCLUSION CRITERIA
EXCLUSION CRITERIA
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gastric ring surgery | Experimental | in this group a gastric ring will be put by surgery. |
|
| nutritional help | Active Comparator | the usual treatment of obesity in France with nutritional care will be dispensed for this arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gastric ring surgery | Procedure |
| ||
| nutritional help |
| Measure | Description | Time Frame |
|---|---|---|
| BMIZ-score evolution in 2 years. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of quality of life scales | 1, 2, 5 and 10 years | |
| Evaluation of des alimentary attitudinal troubles and psychiatrical troubles | 1 year | |
| Evolution of BMIZ-score |
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Inclusion Criteria:
EXCLUSION CRITERIA
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| REGIS COUTANT | Contact | recoutant@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| REGIS COUTANT | UNIVERSITY HOSPITAL OF ANGERS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Angers | Angers | France | 49000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25393047 | Derived | Pourcher G, De Filippo G, Ferretti S, Piquard C, Dagher I, Bougneres P. Short-term results of single-port sleeve gastrectomy in adolescents with severe obesity. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):65-9. doi: 10.1016/j.soard.2014.05.029. Epub 2014 Jun 3. |
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|
| 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 metabolic syndrome parameters. | 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 |
| University Hospital of Caen | Caen | 14033 | France |
|
| University hospital BicĂȘtre | Le Kremlin-BicĂȘtre | 94275 | France |
|
| University Hospital of Lille | Lille | 59037 | France |
|
| University Hospital of Necker | Paris | 75743 | France |
|
| University Hospital of Toulouse | Toulouse | 31059 | France |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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