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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by University Hospital, Angers.
Recruitment status was:  Not yet recruiting
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.

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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700738

Locations
France
University Hospital of Angers
Angers, France, 49000
University Hospital of Caen
Caen, France, 14033
University hospital Bicêtre
Le Kremlin Bicetre, France, 94275
University Hospital of Lille
Lille, France, 59037
University Hospital of Necker
Paris, France, 75743
University Hospital of Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: REGIS COUTANT UNIVERSITY HOSPITAL OF ANGERS
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 December 07, 2016