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.
NCT ID: NCT01700738
Last Updated: 2012-10-04
Study Results
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Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2012-11-30
2015-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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gastric ring surgery
in this group a gastric ring will be put by surgery.
gastric ring surgery
nutritional help
the usual treatment of obesity in France with nutritional care will be dispensed for this arm
nutritional help
Interventions
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gastric ring surgery
nutritional help
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
16 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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REGIS COUTANT
Role: PRINCIPAL_INVESTIGATOR
UNIVERSITY HOSPITAL OF ANGERS
Locations
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University Hospital of Angers
Angers, France, France
University Hospital of Caen
Caen, , France
University hospital Bicêtre
Le Kremlin-Bicêtre, , France
University Hospital of Lille
Lille, , France
University Hospital of Necker
Paris, , France
University Hospital of Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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DOMINIQUE BOUGLE
Role: primary
PIERRE BOUGNIERES
Role: primary
IVA GUEORGUIEVA
Role: primary
OLIVIER GOULET
Role: primary
MAITHE TAUBER
Role: primary
References
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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.
Other Identifiers
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2012 - A00555-38
Identifier Type: -
Identifier Source: org_study_id