Long-Term Outcomes of LSG in Pediatric Patients

Bariatric Surgery Candidate Clinical Trial

Official title:

Long-Term Outcomes of Sleeve Gastrectomy in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04136704
• Other study ID #: LSGKids10
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2019
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: August 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Cardiovascular Risk Factor
• Obesity, Childhood
• Pediatric Obesity

Intervention

Procedure:
• Sleeve gastrectomy
Laparoscopic sleeve gastrectomy

Locations

Country	Name	City	State
Saudi Arabia	King Saud University	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Saud University	New You Medical Center

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (8)

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. — View 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 — View 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. — View 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. — View 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. Review. — View 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 — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change	Weight change according to %excess weight loss (%EWL), %BMI change, % total weight loss (%TWL), BMI change, BMI z-score change	Calculated at each follow-up milestone up to 10 years
Primary	Growth	Measurement of change in growth velocity (height z-score change)	Calculated at each follow-up milestone up to 10 years
Primary	Remission of Type 2 Diabetes	Remission of type 2 diabetes is assessed in accordance with the American Society for Metabolic and Bariatric Surgery (ASMBS) Outcomes Reporting Standards	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
Primary	% Change in Framingham 30-Year Cardiovascular Disease (CVD) Risk	Proportion of patients at risk for a full CVD event according to the Framingham 30-year risk score for CVD at baseline and follow-up	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
Primary	Proportion of participants reporting adverse events	Number of participants with grade 2 or higher complication according to Clavien-Dindo Classification	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
Primary	Number of participants undergoing a reoperative or revisional surgical or endoscopic intervention	Number of participants who underwent reoperation, defined as undergoing subsequent abdominal surgery for sleeve gastrectomy related complications, and revision, defined as undergoing a subsequent bariatric or endobariatric procedure to re-induce weight loss	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