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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.

NCT01700738 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-10-04

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

gastric ring surgery

OTHER

nutritional help

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • REGIS COUTANT · UNIVERSITY HOSPITAL OF ANGERS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01700738 on ClinicalTrials.gov