search
Back to results

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)

Primary Purpose

Obesity

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
gastric ring surgery
nutritional help
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Angers
  • University Hospital of Caen
  • University hospital Bicêtre
  • University Hospital of Lille
  • University Hospital of Necker
  • University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gastric ring surgery

nutritional help

Arm Description

in this group a gastric ring will be put by surgery.

the usual treatment of obesity in France with nutritional care will be dispensed for this arm

Outcomes

Primary Outcome Measures

BMIZ-score evolution in 2 years.

Secondary Outcome Measures

Evolution of quality of life scales
Evaluation of des alimentary attitudinal troubles and psychiatrical troubles
Evolution of BMIZ-score
Evolution of round-waist
Evolution of bodily composition.
Evolution of metabolic syndrome parameters.
Evolution of respiratory parameters: polysomnography
Determination of success factors of the ring.
Study of tolerance of the gastric ring.

Full Information

First Posted
October 2, 2012
Last Updated
October 2, 2012
Sponsor
University Hospital, Angers
search

1. Study Identification

Unique Protocol Identification Number
NCT01700738
Brief Title
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.
Acronym
CHADO
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. NONINCLUSION CRITERIA 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. EXCLUSION CRITERIA Anesthetic contre indication for placement of a gastric laparoscopic. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gastric ring surgery
Arm Type
Experimental
Arm Description
in this group a gastric ring will be put by surgery.
Arm Title
nutritional help
Arm Type
Active Comparator
Arm Description
the usual treatment of obesity in France with nutritional care will be dispensed for this arm
Intervention Type
Procedure
Intervention Name(s)
gastric ring surgery
Intervention Type
Other
Intervention Name(s)
nutritional help
Primary Outcome Measure Information:
Title
BMIZ-score evolution in 2 years.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Evolution of quality of life scales
Time Frame
1, 2, 5 and 10 years
Title
Evaluation of des alimentary attitudinal troubles and psychiatrical troubles
Time Frame
1 year
Title
Evolution of BMIZ-score
Time Frame
1, 5 and 10 years
Title
Evolution of round-waist
Time Frame
1, 2, 5 and 10 years
Title
Evolution of bodily composition.
Time Frame
1, 2, 5 and 10 years
Title
Evolution of metabolic syndrome parameters.
Time Frame
1, 2, 5 and 10 years
Title
Evolution of respiratory parameters: polysomnography
Time Frame
2 years
Title
Determination of success factors of the ring.
Time Frame
2 years
Title
Study of tolerance of the gastric ring.
Time Frame
1, 2, 5 and 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. EXCLUSION CRITERIA 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
REGIS COUTANT
Email
recoutant@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
REGIS COUTANT
Organizational Affiliation
UNIVERSITY HOSPITAL OF ANGERS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
REGIS COUTANT
First Name & Middle Initial & Last Name & Degree
FRANCOISE SCHMITT
First Name & Middle Initial & Last Name & Degree
GUILLAUME PODEVIN
First Name & Middle Initial & Last Name & Degree
JEAN-LOUIS GINIES
First Name & Middle Initial & Last Name & Degree
AGNES SALLE
Facility Name
University Hospital of Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DOMINIQUE BOUGLE
Phone
0231515161
First Name & Middle Initial & Last Name & Degree
DOMINIQUE BOUGLE
First Name & Middle Initial & Last Name & Degree
JULIEN ROD
First Name & Middle Initial & Last Name & Degree
MURIEL LAURANS
First Name & Middle Initial & Last Name & Degree
YANNICK LE ROUX
First Name & Middle Initial & Last Name & Degree
MARIE-ASTRID PIQUET
Facility Name
University hospital Bicêtre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PIERRE BOUGNIERES
Phone
0145217832
First Name & Middle Initial & Last Name & Degree
PIERRE BOUGNIERE
First Name & Middle Initial & Last Name & Degree
GIANPAOLO DE FILIPPO
First Name & Middle Initial & Last Name & Degree
CATHERINE PIQUARD
Facility Name
University Hospital of Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IVA GUEORGUIEVA
Phone
0320446885
First Name & Middle Initial & Last Name & Degree
IVA GUEORGUIEVA
First Name & Middle Initial & Last Name & Degree
JACQUES WEILL
First Name & Middle Initial & Last Name & Degree
ESTELLE AUBRY
First Name & Middle Initial & Last Name & Degree
FRANCOIS PATTOU
First Name & Middle Initial & Last Name & Degree
MARIE PIGEYRE
Facility Name
University Hospital of Necker
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
OLIVIER GOULET
Phone
0144492501
First Name & Middle Initial & Last Name & Degree
OLIVIER GOULET
First Name & Middle Initial & Last Name & Degree
MYRIAM TYAN-DABBAS
First Name & Middle Initial & Last Name & Degree
NAZIHA KHEN-DUNLOP
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MAITHE TAUBER
Phone
0534558555
First Name & Middle Initial & Last Name & Degree
MAITHE TAUBER
First Name & Middle Initial & Last Name & Degree
GWENAELLE DIENE
First Name & Middle Initial & Last Name & Degree
BEATRICE JOURET
First Name & Middle Initial & Last Name & Degree
PATRICK RITZ

12. IPD Sharing Statement

Citations:
PubMed Identifier
25393047
Citation
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.
Results Reference
derived

Learn more about this trial

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.

We'll reach out to this number within 24 hrs