Clinical trial NCT04136704: Long-Term Outcomes of LSG in Pediatric Patients
Official title: Long-Term Outcomes of Sleeve Gastrectomy in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Childhood
Bariatric Surgery Candidate
Cardiovascular Risk Factor
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: New You Medical Center
First posted: 2019-10-23
Enrollment: 10000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents who meet the inclusion criteria, fail to lose weight under an intensive family-based nutrition and lifestyle program, who signed an informed consent to participate in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight Change
timeFrame: Calculated at each follow-up milestone up to 10 years
measure: Growth
timeFrame: Calculated at each follow-up milestone up to 10 years
measure: Remission of Type 2 Diabetes
timeFrame: 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
measure: % Change in Framingham 30-Year Cardiovascular Disease (CVD) Risk
timeFrame: 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
measure: Proportion of participants reporting adverse events
timeFrame: 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
measure: Number of participants undergoing a reoperative or revisional surgical or endoscopic intervention
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Aayed R Alqahtani, MD
role: STUDY_CHAIR
References:
citation: Elahmedi MO, Alqahtani AR. Evidence Base for Multidisciplinary Care of Pediatric/Adolescent Bariatric Surgery Patients. Curr Obes Rep. 2017 Sep;6(3):266-277. doi: 10.1007/s13679-017-0278-3.
citation: Alqahtani AR, Elahmedi M, Alqahtani YA. Bariatric surgery in monogenic and syndromic forms of obesity. Semin Pediatr Surg. 2014 Feb;23(1):37-42. doi: 10.1053/j.sempedsurg.2013.10.013. Epub 2013 Nov 15.
citation: Alqahtani A, Elahmedi M, Alswat K, Arafah M, Fagih M, Lee J. Features of nonalcoholic steatohepatitis in severely obese children and adolescents undergoing sleeve gastrectomy. Surg Obes Relat Dis. 2017 Sep;13(9):1599-1609. doi: 10.1016/j.soard.2017.04.005. Epub 2017 Apr 7.
citation: Alqahtani A, Elahmedi M, Qahtani AR. Laparoscopic Sleeve Gastrectomy in Children Younger Than 14 Years: Refuting the Concerns. Ann Surg. 2016 Feb;263(2):312-9. doi: 10.1097/SLA.0000000000001278.
citation: Alqahtani AR, Elahmedi MO. Pediatric bariatric surgery: the clinical pathway. Obes Surg. 2015 May;25(5):910-21. doi: 10.1007/s11695-015-1586-x.
citation: Alqahtani A, Alamri H, Elahmedi M, Mohammed R. Laparoscopic sleeve gastrectomy in adult and pediatric obese patients: a comparative study. Surg Endosc. 2012 Nov;26(11):3094-100. doi: 10.1007/s00464-012-2345-x. Epub 2012 May 31.
citation: Alqahtani AR, Antonisamy B, Alamri H, Elahmedi M, Zimmerman VA. Laparoscopic sleeve gastrectomy in 108 obese children and adolescents aged 5 to 21 years. Ann Surg. 2012 Aug;256(2):266-73. doi: 10.1097/SLA.0b013e318251e92b.
citation: Alqahtani AR, Elahmedi MO, Al Qahtani AR, Lee J, Butler MG. Laparoscopic sleeve gastrectomy in children and adolescents with Prader-Willi syndrome: a matched-control study. Surg Obes Relat Dis. 2016 Jan;12(1):100-10. doi: 10.1016/j.soard.2015.07.014. Epub 2015 Jul 22.
citation: Alqahtani AR, Elahmedi M, Abdurabu HY, Alqahtani S. Ten-Year Outcomes of Children and Adolescents Who Underwent Sleeve Gastrectomy: Weight Loss, Comorbidity Resolution, Adverse Events, and Growth Velocity. J Am Coll Surg. 2021 Dec;233(6):657-664. doi: 10.1016/j.jamcollsurg.2021.08.678. Epub 2021 Sep 23.