Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
Study NCT ID:
NCT04136704
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2019-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Outcomes of LSG in Pediatric Patients
Sponsor:
King Saud University
Organization:
Study Overview
Official Title:
Long-Term Outcomes of Sleeve Gastrectomy in Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: