Status:
COMPLETED
Long-Term Outcomes of LSG in Pediatric Patients
Lead Sponsor:
King Saud University
Collaborating Sponsors:
New You Medical Center
Conditions:
Obesity, Childhood
Bariatric Surgery Candidate
Eligibility:
All Genders
5-21 years
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 hig...
Eligibility Criteria
Inclusion
- 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
- Cardiac failure
- Respiratory failure
- Immune deficiency
- GI disease
- Age greater than 21 years
- Inability to sign informed consent / assent
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT04136704
Start Date
January 1 2008
End Date
August 1 2019
Last Update
October 23 2019
Active Locations (1)
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1
King Saud University
Riyadh, Saudi Arabia