Bariatric Surgery Candidate, Cardiovascular Risk Factor, Obesity, Childhood
Conditions
Brief summary
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
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.
Interventions
PROCEDURESleeve gastrectomy
Laparoscopic sleeve gastrectomy
Sponsors
New You Medical Center
King Saud University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | 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 |
| Growth | Calculated at each follow-up milestone up to 10 years | Measurement of change in growth velocity (height z-score change) |
| Remission of Type 2 Diabetes | 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 |
| % Change in Framingham 30-Year Cardiovascular Disease (CVD) Risk | 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 |
| Proportion of participants reporting adverse events | 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 |
| Number of participants undergoing a reoperative or revisional surgical or endoscopic intervention | 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 |
Countries
Saudi Arabia
Outcome results
None listed