Long-Term Outcomes of LSG in Pediatric Patients

NCT04136704 | Completed DMC

• 1 other identifier: LSGKids10
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood; Bariatric Surgery Candidate; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (6)

• 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

• Growth

  Measurement of change in growth velocity (height z-score change)

  Calculated at each follow-up milestone up to 10 years

• 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

• % 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

• 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

• 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

Study Arms (2)

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.

Procedure: Sleeve gastrectomy

Sleeve Gastrectomy in Adult Patients

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

Procedure: Sleeve gastrectomy

Interventions

Sleeve gastrectomy PROCEDURE

Laparoscopic sleeve gastrectomy

Also known as: Vertical Sleeve Gastrectomy

Sleeve Gastrectomy in Adult Patients; Sleeve Gastrectomy in Pediatric Patients

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Cardiac failure
• Respiratory failure
• Immune deficiency
• GI disease
• Age greater than 21 years
• Inability to sign informed consent / assent

Sponsors & Collaborators

• King Saud University: lead
• New You Medical Center: collaborator

Study Sites (1)

King Saud University

Riyadh, Saudi Arabia

Location

Related Publications (9)

• 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.

  PMID: 28755177 BACKGROUND

• 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.

  PMID: 24491367 BACKGROUND

• 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.

  PMID: 28600116 RESULT

• 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.

  PMID: 26496081 RESULT

• 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.

  PMID: 25739495 RESULT

• 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.

  PMID: 22648112 RESULT

• 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.

  PMID: 22504281 RESULT

• 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.

  PMID: 26431633 RESULT

• 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.

  PMID: 34563670 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, subcutaneous and visceral fat, and liver samples obtained from patients who consent to have sample storage in liquid nitrogen for research purposes.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aayed R Alqahtani, MD

  King Saud University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: January 1, 2008
• Primary Completion: January 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)