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
1 other identifier
interventional
200
1 country
6
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
- 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
- Obesity "common" non-syndromic.
- Medical decision of surgical placement of laparoscopic gastric banding.
- Adolescent and family who understand and accept the need for medical and surgical follow long term.
- Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up.
- Obtention of oral and written consent of the adolescent and the parents.
- Parents and adolescents affiliated with the social security system.
- Intellectual Deficit.
- psychiatrics contraindication of surgical placement of laparoscopic gastric banding.
- Obesity with severe binge eating.
- Pregnancy or wishes of pregnancy in the following year.
- Non accession adolescent and / or family in the process of medical care before inclusion.
- Predictable post surgical monitoring difficulties.
- Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.
- Participation in a clinical study evaluating a treatment during the 2 years of the study.
- Anesthetic contre indication for placement of a gastric laparoscopic.
- IMC\> 50 kg/m2 the day of inclusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 obesity
Started Nov 2012
Typical duration for phase_4 obesity
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedOctober 4, 2012
October 1, 2012
3 years
October 2, 2012
October 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
BMIZ-score evolution in 2 years.
2 years
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
gastric ring surgery
EXPERIMENTALin this group a gastric ring will be put by surgery.
nutritional help
ACTIVE COMPARATORthe usual treatment of obesity in France with nutritional care will be dispensed for this arm
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Obesity "common" non-syndromic.
- Medical decision of surgical placement of laparoscopic gastric banding.
- Adolescent and family who understand and accept the need for medical and surgical follow long term.
- Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up.
- Obtention of oral and written consent of the adolescent and the parents.
- Parents and adolescents affiliated with the social security system.
You may not qualify if:
- Intellectual Deficit.
- psychiatrics contraindication of surgical placement of laparoscopic gastric banding.
- Obesity with severe binge eating.
- Pregnancy or wishes of pregnancy in the following year.
- Predictable post surgical monitoring difficulties.
- Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.
- Participation in a clinical study evaluating a treatment during the 2 years of the study.
- Anesthetic contre indication for placement of a gastric laparoscopic.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University Hospital of Angers
Angers, France, 49000, France
University Hospital of Caen
Caen, 14033, France
University hospital Bicêtre
Le Kremlin-Bicêtre, 94275, France
University Hospital of Lille
Lille, 59037, France
University Hospital of Necker
Paris, 75743, France
University Hospital of Toulouse
Toulouse, 31059, France
Related Publications (1)
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.
PMID: 25393047DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
REGIS COUTANT
UNIVERSITY HOSPITAL OF ANGERS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2012
First Posted
October 4, 2012
Study Start
November 1, 2012
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
October 4, 2012
Record last verified: 2012-10