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.

Phase 4

• Conditions: Obesity
• Interventions: Procedure: gastric ring surgery; Other: nutritional help

• Registration Number: NCT01700738
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-10
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Last Update Submitted: 2012-10-02
• Study First Posted: 2012-10-04
• Last Update Posted: 2012-10-04
• Study Start: 2012-11
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gastric ring surgery	gastric ring surgery	in this group a gastric ring will be put by surgery.
nutritional help	nutritional help	the usual treatment of obesity in France with nutritional care will be dispensed for this arm

Primary Outcome Measures

Name	Time	Method
BMIZ-score evolution in 2 years.	2 years

Secondary Outcome Measures

Name	Time	Method
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 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	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

Trial Locations

Locations (6)

University Hospital of Lille; 🇫🇷 Lille, France

University Hospital of Caen; 🇫🇷 Caen, France

University hospital Bicêtre; 🇫🇷 Le Kremlin Bicetre, France

University Hospital of Toulouse; 🇫🇷 Toulouse, France

University Hospital of Angers; 🇫🇷 Angers, France

University Hospital of Necker; 🇫🇷 Paris, France