Long-Term Outcomes of Sleeve Gastrectomy in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Weight Change
研究概览
简要总结
This project aims to assess the short- and long-term safety and efficacy of bariatric surgery in children and adolescents compared to adults.
详细描述
Obesity affects children and adults across all age groups. More than 30% of children and adolescents in the United States are currently overweight or obese, whereas the prevalence of obesity is as high as 21.4% in young children.This increase in prevalence is associated with significant short- and long-term health implications and necessitates effective interventions that induce significant weight loss and ameliorate associated conditions.
The results of weight loss surgery in children and adolescents are still scarce, despite recent studies suggesting favorable short- and intermediate-term outcomes that are comparable to those in adults. Although evidence continues to emerge, this solution is still denied to young children.
Bariatric surgery has proven safety and efficacy in inducing significant weight loss and co-morbidity resolution in children and adolescents. However, long-term evidence in this age group is yet to be reported. This project aims to study long-term weight loss, cardiovascular risk factors, growth and morbidity in severely obese children and adolescents (aged 5-21 years) who undergo laparoscopic sleeve gastrectomy (LSG).
This study aims to narrow the current evidence gap by studying the long-term effects of bariatric surgery in children and adolescents with severe obesity.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 5 to 21 years
- •BMI higher than the 140% of the 95th percentile for age and gender
- •failure to lose satisfactory weight during a period of at least 6 months
- •Supportive psychological evaluation
- •Presence of a dedicated caretaker from the patient's family
- •Motivation, realistic expectations
- •Informed consent or assent with concomitant parental consent for patients aged < 17 years
- •Absence of medical and surgical contraindications
排除标准
- •Cardiac failure
- •Respiratory failure
- •Immune deficiency
- •GI disease
- •Age greater than 21 years
- •Inability to sign informed consent / assent
结局指标
主要结局
Weight Change
时间窗: Calculated at each follow-up milestone up to 10 years
Weight change according to %excess weight loss (%EWL), %BMI change, % total weight loss (%TWL), BMI change, BMI z-score change
Proportion of participants reporting adverse events
时间窗: 30-day morbidity and mortality, and events reported during predetermined follow-up intervals up to 10 years, i.e. short-term: 1-3 years; medium-term: 4-6 years; long-term: 7-10 years
Number of participants with grade 2 or higher complication according to Clavien-Dindo Classification
Remission of Type 2 Diabetes
时间窗: Predetermined follow-up intervals up to 10 years, i.e. short-term: 1-3 years; medium-term: 4-6 years; long-term: 7-10 years
Remission of type 2 diabetes is assessed in accordance with the American Society for Metabolic and Bariatric Surgery (ASMBS) Outcomes Reporting Standards
Growth
时间窗: Calculated at each follow-up milestone up to 10 years
Measurement of change in growth velocity (height z-score change)
% Change in Framingham 30-Year Cardiovascular Disease (CVD) Risk
时间窗: Predetermined follow-up intervals up to 10 years, i.e. short-term: 1-3 years; medium-term: 4-6 years; long-term: 7-10 years
Proportion of patients at risk for a full CVD event according to the Framingham 30-year risk score for CVD at baseline and follow-up
Number of participants undergoing a reoperative or revisional surgical or endoscopic intervention
时间窗: Predetermined follow-up intervals up to 10 years, i.e. short-term: 1-3 years; medium-term: 4-6 years; long-term: 7-10 years
Number of participants who underwent reoperation, defined as undergoing subsequent abdominal surgery for sleeve gastrectomy related complications, and revision, defined as undergoing a subsequent bariatric or endobariatric procedure to re-induce weight loss
次要结局
未报告次要终点
研究者
Aayed Alqahtani
Professor of Surgery
King Saud University