Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effective for Resolution of Cardiovascular Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Percent of loss of excess weight following laparoscopic sleeve gastrectomy in severely obese adolescents
研究概览
简要总结
Severe obesity (SO), defined as BMI≥95th percentile, has increased worldwide among adolescents. American studies estimated that 1.3-2.8% of 12-19-year-old individuals have a BMI >40 kg/m2 or a BMI >35 kg/m2 with at least one serious co-morbidity. The immediate and long-term risks associated with SO in adolescents include cardiovascular and metabolic diseases, obstructive sleep apnoea and nonalcoholic fatty liver disease. However, the results of sleeve gastrectomy in adolescents are still uncertain.
Objective and hypotheses: Investigators aimed to assess the long-term safety, efficacy, and cardiovascular risk changes of laparoscopic sleeve gastrectomy in adolescents with SO.
Method: Longitudinal retrospective study of 22 adolescents with SO who underwent laparoscopic sleeve gastrectomy. Clinical and metabolic variables immediately before surgery and after 6, 12, 18 and 24 months were assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages of 14 and 19
- •submitted to LSG between 2007 and
- •attended the child obesity clinic of the pediatric endocrinology department of the Instituto da Criança da Universidade de São Paulo (Children's Institute of University of São Paulo).
- •received clinical and pharmacological treatment for at least 6 months before surgery and were followed by a multidisciplinary team including a pediatric endocrinologist, a nutritionist, a psychologist and a physical educator.
- •BMI > 40 kg/m2 or BMI > 35 kg/m2 with comorbidities and failed to achieve significant weight loss (10% of initial weight at 6 months) through clinical treatment.
- •Both the patients and their guardians were informed about the risks and benefits of surgery and provided informed consent.
排除标准
- •it was a retrospective study
结局指标
主要结局
Percent of loss of excess weight following laparoscopic sleeve gastrectomy in severely obese adolescents
时间窗: up to 24 months
weight
percent of reduction in body mass index following laparoscopic sleeve gastrectomy in severely obese adolescents
时间窗: up to 24 months
weight and stature
次要结局
- Changes in insulin resistance following laparoscopic sleeve gastrectomy in severely obese adolescents(up to 24 months)
- Changes in total cholesterol and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents(up to 24 months)
- Changes in abdominal ultrasonography ( steatosis )following laparoscopic sleeve gastrectomy in severely obese adolescents(up to 24 months)
- Changes in echocardiogram ( concentric hypertrophy of left ventricle )following laparoscopic sleeve gastrectomy in severely obese adolescents(up to 24 months)
- Changes in glucose and and fractions following laparoscopic sleeve gastrectomy in severely obese adolescents(up to 24 months)
- Changes in triglycerides following laparoscopic sleeve gastrectomy in severely obese adolescents(up to 24 months)
- Changes in transaminases following laparoscopic sleeve gastrectomy in severely obese adolescents(up to 24 months)
- Changes in uric acid following laparoscopic sleeve gastrectomy in severely obese adolescents(up to 24 months)
研究者
Ruth Rocha Franco
MD
University of Sao Paulo General Hospital