Long-Term Outcomes of LSG in Pediatric Patients

Study Overview
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Brief Summary
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This project aims to assess the short- and long-term safety and efficacy of bariatric surgery in children and adolescents compared to adults.

Detailed Description
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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.

Official Title
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Long-Term Outcomes of Sleeve Gastrectomy in Children and Adolescents

Conditions
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Obesity, Childhood, Bariatric Surgery Candidate, Cardiovascular Risk Factor

Intervention / Treatment
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* Procedure: Sleeve gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Cardiac failure Respiratory failure Immune deficiency GI disease Age greater than 21 years Inability to sign informed consent / assent

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sleeve Gastrectomy in Pediatric Patients<br>Laparoscopic Sleeve Gastrectomy will be offered as an adjuvant to a multidisciplinary family-based program that focuses on nutrition, physical activity, and behavioral counseling. | Procedure: Sleeve gastrectomy<br>* Laparoscopic sleeve gastrectomy<br>* Other names: Vertical Sleeve Gastrectomy;|
| Sleeve Gastrectomy in Adult Patients<br>This comparison group will be composed of adult patients who undergo sleeve gastrectomy | Procedure: Sleeve gastrectomy<br>* Laparoscopic sleeve gastrectomy<br>* Other names: Vertical Sleeve Gastrectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change | Weight change according to %excess weight loss (%EWL), %BMI change, % total weight loss (%TWL), BMI change, BMI z-score change | Calculated at each follow-up milestone up to 10 years | 
| Growth | Measurement of change in growth velocity (height z-score change) | Calculated at each follow-up milestone up to 10 years | 
| Remission of Type 2 Diabetes | Remission of type 2 diabetes is assessed in accordance with the American Society for Metabolic and Bariatric Surgery (ASMBS) Outcomes Reporting Standards | 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 | 
| % Change in Framingham 30-Year Cardiovascular Disease (CVD) Risk | 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 | 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 participants reporting adverse events | Number of participants with grade 2 or higher complication according to Clavien-Dindo Classification | 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 undergoing a reoperative or revisional surgical or endoscopic intervention | 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 | 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 |