Clinical trial NCT01700738: 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.
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2012-10-04
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: BMIZ-score evolution in 2 years.
timeFrame: 2 years
Secondary outcomes:
measure: Evolution of quality of life scales
timeFrame: 1, 2, 5 and 10 years
measure: Evaluation of des alimentary attitudinal troubles and psychiatrical troubles
timeFrame: 1 year
measure: Evolution of BMIZ-score
timeFrame: 1, 5 and 10 years
measure: Evolution of round-waist
timeFrame: 1, 2, 5 and 10 years
measure: Evolution of bodily composition.
timeFrame: 1, 2, 5 and 10 years
measure: Evolution of metabolic syndrome parameters.
timeFrame: 1, 2, 5 and 10 years
measure: Evolution of respiratory parameters: polysomnography
timeFrame: 2 years
measure: Determination of success factors of the ring.
timeFrame: 2 years
measure: Study of tolerance of the gastric ring.
timeFrame: 1, 2, 5 and 10 years
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
city: Caen
country: France
facility: University Hospital of Caen
city: Le Kremlin Bicetre
country: France
facility: University hospital Bicêtre
city: Lille
country: France
facility: University Hospital of Lille
city: Paris
country: France
facility: University Hospital of Necker
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: UNIVERSITY HOSPITAL OF ANGERS
name: REGIS COUTANT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.