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)

This study is not yet open for participant recruitment.
Verified October 2012 by University Hospital, Angers
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01700738
First received: October 2, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Obesity
Procedure: gastric ring surgery
Other: nutritional help
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • BMIZ-score evolution in 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evolution of quality of life scales [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
  • Evaluation of des alimentary attitudinal troubles and psychiatrical troubles [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Evolution of BMIZ-score [ Time Frame: 1, 5 and 10 years ] [ Designated as safety issue: No ]
  • Evolution of round-waist [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
  • Evolution of bodily composition. [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
  • Evolution of metabolic syndrome parameters. [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: Yes ]
  • Evolution of respiratory parameters: polysomnography [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Determination of success factors of the ring. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Study of tolerance of the gastric ring. [ Time Frame: 1, 2, 5 and 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gastric ring surgery
in this group a gastric ring will be put by surgery.
Procedure: gastric ring surgery
Active Comparator: nutritional help
the usual treatment of obesity in France with nutritional care will be dispensed for this arm
Other: nutritional help

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700738

Contacts
Contact: REGIS COUTANT recoutant@chu-angers.fr

Locations
France
University Hospital of Angers Not yet recruiting
Angers, France, 49000
Principal Investigator: REGIS COUTANT         
Sub-Investigator: FRANCOISE SCHMITT         
Principal Investigator: GUILLAUME PODEVIN         
Sub-Investigator: JEAN-LOUIS GINIES         
Sub-Investigator: AGNES SALLE         
University Hospital of Caen Not yet recruiting
Caen, France, 14033
Contact: DOMINIQUE BOUGLE    0231515161      
Principal Investigator: DOMINIQUE BOUGLE         
Sub-Investigator: JULIEN ROD         
Sub-Investigator: MURIEL LAURANS         
Principal Investigator: YANNICK LE ROUX         
Sub-Investigator: MARIE-ASTRID PIQUET         
University hospital Bicêtre Not yet recruiting
Le Kremlin Bicetre, France, 94275
Contact: PIERRE BOUGNIERES    0145217832      
Principal Investigator: PIERRE BOUGNIERE         
Sub-Investigator: GIANPAOLO DE FILIPPO         
Sub-Investigator: CATHERINE PIQUARD         
University Hospital of Lille Not yet recruiting
Lille, France, 59037
Contact: IVA GUEORGUIEVA    0320446885      
Principal Investigator: IVA GUEORGUIEVA         
Sub-Investigator: JACQUES WEILL         
Principal Investigator: ESTELLE AUBRY         
Sub-Investigator: FRANCOIS PATTOU         
Sub-Investigator: MARIE PIGEYRE         
University Hospital of Necker Not yet recruiting
Paris, France, 75743
Contact: OLIVIER GOULET    0144492501      
Principal Investigator: OLIVIER GOULET         
Sub-Investigator: MYRIAM TYAN-DABBAS         
Principal Investigator: NAZIHA KHEN-DUNLOP         
University Hospital of Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: MAITHE TAUBER    0534558555      
Principal Investigator: MAITHE TAUBER         
Sub-Investigator: GWENAELLE DIENE         
Sub-Investigator: BEATRICE JOURET         
Sub-Investigator: PATRICK RITZ         
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: REGIS COUTANT UNIVERSITY HOSPITAL OF ANGERS
  More Information

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01700738     History of Changes
Other Study ID Numbers: 2012 - A00555-38
Study First Received: October 2, 2012
Last Updated: October 2, 2012
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014