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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. (CHADO)

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

October 2, 2012
October 2, 2012
November 2012
November 2015   (final data collection date for primary outcome measure)
BMIZ-score evolution in 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • Procedure: gastric ring surgery
  • Other: nutritional help
  • Experimental: gastric ring surgery
    in this group a gastric ring will be put by surgery.
    Intervention: Procedure: gastric ring surgery
  • Active Comparator: nutritional help
    the usual treatment of obesity in France with nutritional care will be dispensed for this arm
    Intervention: Other: nutritional help
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
12 Years to 16 Years
No
Contact: REGIS COUTANT recoutant@chu-angers.fr
France
 
NCT01700738
2012 - A00555-38
No
University Hospital, Angers
University Hospital, Angers
Not Provided
Principal Investigator: REGIS COUTANT UNIVERSITY HOSPITAL OF ANGERS
University Hospital, Angers
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP