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.

Obesity Clinical Trial

— CHADO  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01700738
• Other study ID #: 2012 - A00555-38
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 2, 2012
• Last updated: October 2, 2012
• Start date: November 2012
• Est. completion date: November 2015

Study information

• Verified date: October 2012
• Source: University Hospital, Angers
• Contact: REGIS COUTANT
• Email: recoutant[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Procedure:
• gastric ring surgery

Other:
• nutritional help

Locations

Country	Name	City	State
France	University Hospital of Angers	Angers
France	University Hospital of Caen	Caen
France	University hospital Bicêtre	Le Kremlin Bicetre
France	University Hospital of Lille	Lille
France	University Hospital of Necker	Paris
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMIZ-score evolution in 2 years.		2 years	No
Secondary	Evolution of quality of life scales		1, 2, 5 and 10 years	No
Secondary	Evaluation of des alimentary attitudinal troubles and psychiatrical troubles		1 year	Yes
Secondary	Evolution of BMIZ-score		1, 5 and 10 years	No
Secondary	Evolution of round-waist		1, 2, 5 and 10 years	No
Secondary	Evolution of bodily composition.		1, 2, 5 and 10 years	No
Secondary	Evolution of metabolic syndrome parameters.		1, 2, 5 and 10 years	Yes
Secondary	Evolution of respiratory parameters: polysomnography		2 years	Yes
Secondary	Determination of success factors of the ring.		2 years	No
Secondary	Study of tolerance of the gastric ring.		1, 2, 5 and 10 years	Yes