Outcomes Comparison Between Gastric Band, Laparoscopic Sleeve Gastrectomy, and Gastric Bypass Surgeries in Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Glucose Tolerance
研究概览
简要总结
Determine the short and long term safety and efficacy of the Gastric bypass , laparoscopic sleeve gastrectomy, and Gastric banding (LAGB) on severely obese adolescents. The procedure selection is made by the patient or patient and guardian. This is not a randomized trial.
详细描述
Twenty-six obese adolescents with plans to undergo bariatric surgery for clinical treatment will be recruited for research study during screening process at the Yale Adolescent Bariatric Surgery Clinic. After the appropriate discussion with surgeon, the choice of procedure will be made by subject and legal guardian.
Every bariatric patient must have completed the thorough six-month evaluation period established by the Yale's Adolescent Bariatric Clinic.
This standard of care pre-operative testing provides as a screening tool to ensure every adolescent bariatric patient is mentally and physically appropriate for this surgery.
- Monthly visits with clinician (Pediatric Obesity/Diabetology Expert) and dietician to discuss lifestyle change management and anthropometric measures.
- Psychiatrist or psychologist to screen for depression, uncontrollable psychosis, suicidal ideation, and hostile or unsupportive family environment.
- Bone age will be obtained to ensure subject has reached or near full growth potential.
- Pediatric Cardiology for echocardiogram to rule out left ventricular hypertrophy.
- Oral glucose tolerance test to assess glucose status and degree of insulin resistance.
- Blood work to assess hepatic and kidney function, nutritional deficiencies, hormonal profile, and hyperlipidemia.
- Pediatric Pulmonary for sleep study and Pulmonary Function Tests (PFTs) to rule out obstructive sleep apnea.
When a subject is approved for surgery, he or she will meet with Bariatric Surgeon to discuss benefits and risks of each bariatric surgery. After the appropriate discussion with surgeon, the choice of procedure will be made by subject and legal guardian. For research purposes, we seek to monitor the progress of the patients enrolled in Yale's Adolescent Bariatric Surgery Clinic. Collecting pre and post long term operative data will allow us to describe this efficacy and potential complications that arise with RYGB vs LAGB.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Youth 14-19yrs
- •6 months of attempts at weight management by primary care physician or Pediatric Endocrinologist
- •Approval by the Adolescent Bariatric Surgery clinic to undergo surgery
- •Physically or nearly physically mature
- •BMI >= 35kg/m2 with one obesity related comorbidities or BMI >= 40 kg/m2
- •Commitment to avoid pregnancy for at least 1 year postoperatively
- •Capability and willingness to adhere to nutritional guidelines postoperatively
- •Informed consent to surgical treatment
- •Demonstration of decisional capacity
- •Supportive family environment
排除标准
- •Inability to be approved by Yale Adolescent Bariatric Surgery clinic to undergo surgery
- •Uncontrolled psychosis
- •Uncontrolled depression
- •Drug or alcohol abuse
- •History of congenital or acquired anomalies of gastrointestinal tract
- •Esophageal anatomical abnormality or dysmotility
- •Inflammatory bowel disease
- •Severe cardiopulmonary disease
- •Severe coagulopathy
- •Hepatic insufficiency or cirrhosis
- •Presence of localized or systemic infection at time of surgery
- •Obesity related to central causes: Prader Willi and hypothalamic abnormalities
- •Non-compliance to nutrition plan, exercise, and behavioral counseling/treatment
- •Pregnant, breast-feeding or planning of becoming pregnant within 1-2 years of surgery
结局指标
主要结局
Change in Glucose Tolerance
时间窗: baseline, 2 month, 3 month, 12 month
Glucose tolerance changes measured by 3 hour oral glucose tolerance test.
次要结局
- Change in Anthropometric data(Baseline, 2 weeks, 2 mnths, 3 months, 6 months, 12 months, 24 months)
- Changes in nutritional health(Baseline, 2 weeks, 2 mnths, 3 months, 6 months, 12 months, 24 months)