Long-Term Outcomes of LSG in Pediatric Patients

King Saud University

Status: Completed

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

Treatments: Procedure: Sleeve gastrectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04136704

LSGKids10

Details and patient eligibility

About

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

Full 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.

Enrollment: 10,000 patients

Sex: All

Ages: 5 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

10,000 participants in 2 patient groups

Sleeve Gastrectomy in Pediatric Patients

Description:

Laparoscopic Sleeve Gastrectomy will be offered as an adjuvant to a multidisciplinary family-based program that focuses on nutrition, physical activity, and behavioral counseling.

Treatment:

Procedure: Sleeve gastrectomy

Sleeve Gastrectomy in Adult Patients

Description:

This comparison group will be composed of adult patients who undergo sleeve gastrectomy

Treatment:

Procedure: Sleeve gastrectomy