Clinical trial
Comparison Between Gastric Band, Laparoscopic Sleeve Gastrectomy, Gastric Bypass Surgeries
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02004561
Active, not recruitingNot applicableObservational
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age14 Years to 19 Years
SexAll
Healthy volunteersNot accepted
ConditionObese Adolescents
Full registry criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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
Treatments and study arms
The registry does not list a named intervention.
Primary outcomes
Change in Glucose Tolerancebaseline, 2 month, 3 month, 12 month
Glucose tolerance changes measured by 3 hour oral glucose tolerance test.
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Yale Pediatric Endocrinology Clinic🇺🇸 New Haven, Connecticut, United States