跳至主要内容
临床试验/NCT01700738
NCT01700738Unknown4 期

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.

University Hospital, Angers12 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年11月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
200
试验地点
12
主要终点
BMIZ-score evolution in 2 years.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

BMIZ-score evolution in 2 years.

时间窗: 2 years

次要结局

  • 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)
  • Evolution of metabolic syndrome parameters.(1, 2, 5 and 10 years)
  • Evolution of respiratory parameters: polysomnography(2 years)
  • Determination of success factors of the ring.(2 years)
  • Study of tolerance of the gastric ring.(1, 2, 5 and 10 years)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (12)

Loading locations...

相似试验