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Obesity, ChildhoodNCT04136704

Long-Term Outcomes of LSG in Pediatric Patients

An observational study of Obesity, Childhood and Bariatric Surgery Candidate, run by King Saud University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 21 years
What is being tested?
Sleeve gastrectomy
Type of treatment
Surgery or procedure
How many people
10,000 participants
Where
1 siteSaudi Arabia
Study dates
1 Jan 2008to 1 Aug 2019
How long will I take part?
10 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • King Saud University

    Riyadh

Other trials in Saudi Arabia

About this study

Official title: Long-Term Outcomes of Sleeve Gastrectomy in Children and Adolescents

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

Read the 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.

Being tested
Sleeve gastrectomy
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleeve gastrectomyProcedure or surgery

    Also called Vertical Sleeve Gastrectomy

    Laparoscopic sleeve gastrectomy

Study groups in NCT04136704
Study groupRoleWhat they receive
Sleeve Gastrectomy in Pediatric PatientsLaparoscopic Sleeve Gastrectomy will be offered as an adjuvant to a multidisciplinary family-based program that focuses on nutrition, physical activity, and behavioral counseling.
Receives: Procedure: Sleeve gastrectomy
Sleeve Gastrectomy in Adult PatientsThis comparison group will be composed of adult patients who undergo sleeve gastrectomy
Receives: Procedure: Sleeve gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Change

    Weight change according to %excess weight loss (%EWL), %BMI change, % total weight loss (%TWL), BMI change, BMI z-score change

    Measured: Calculated at each follow-up milestone up to 10 years

  2. Growth

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

    Measured: Calculated at each follow-up milestone up to 10 years

  3. 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

    Measured: 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

  4. % 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

    Measured: 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

  5. Proportion of participants reporting adverse events

    Number of participants with grade 2 or higher complication according to Clavien-Dindo Classification

    Measured: 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

  6. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start1 Jan 2008
  3. Primary completion1 Jan 2019
  4. Study completion1 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
10,000 participants (actual)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04136704
Sponsor's protocol ID
LSGKids10
Status last verified
Oct 2019
First submitted
21 Oct 2019
Last updated
23 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28755177

  • 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.

    PubMed 24491367

  • 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.

    PubMed 28600116

  • 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.

    PubMed 26496081

  • 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.

    PubMed 25739495

  • 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.

    PubMed 22648112

  • 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.

    PubMed 22504281

  • 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.

    PubMed 26431633

  • 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.

    PubMed 34563670

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Childhood and Bariatric Surgery Candidate, run by King Saud University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change (time frame: Calculated at each follow-up milestone up to 10 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04136704, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.

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