Long-Term Outcomes of LSG in Pediatric Patients

NCT ID: NCT04136704

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-01
• Study Completion Date: 2019-08-01

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.

Conditions

Obesity, Childhood; Bariatric Surgery Candidate; Cardiovascular Risk Factor

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Sleeve Gastrectomy in Pediatric Patients

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

Sleeve gastrectomy

Intervention Type: PROCEDURE

Laparoscopic sleeve gastrectomy

Sleeve Gastrectomy in Adult Patients

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

Sleeve gastrectomy

Intervention Type: PROCEDURE

Laparoscopic sleeve gastrectomy

Interventions

Sleeve gastrectomy

Laparoscopic sleeve gastrectomy

Intervention Type: PROCEDURE

Other Intervention Names

Vertical Sleeve Gastrectomy

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New You Medical Center

UNKNOWN

Sponsor Role: collaborator

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Aayed Alqahtani

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aayed R Alqahtani, MD

Role: STUDY_CHAIR

King Saud University

Locations

King Saud University

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

References

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.

Reference Type: BACKGROUND

PMID: 28755177 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24491367 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28600116 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26496081 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25739495 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22648112 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22504281 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26431633 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34563670 (View on PubMed)

Other Identifiers

LSGKids10

Identifier Type: -

Identifier Source: org_study_id