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)

University Hospital, Angers

Status and phase: Unknown; Phase 4

Conditions: Obesity

Treatments: Other: nutritional help; Procedure: gastric ring surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01700738

2012 - A00555-38

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

gastric ring surgery

Experimental group

Description:

in this group a gastric ring will be put by surgery.

Treatment:

Procedure: gastric ring surgery

nutritional help

Active Comparator group

Description:

the usual treatment of obesity in France with nutritional care will be dispensed for this arm

Treatment:

Other: nutritional help