- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04136704
Long-Term Outcomes of LSG in Pediatric Patients
Long-Term Outcomes of Sleeve Gastrectomy in Children and Adolescents
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Riyadh, Saudi Arabia
- King Saud University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Laparoscopic sleeve gastrectomy
Other Names:
|
Sleeve Gastrectomy in Adult Patients
This comparison group will be composed of adult patients who undergo sleeve gastrectomy
|
Laparoscopic sleeve gastrectomy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Change
Time Frame: Calculated at each follow-up milestone up to 10 years
|
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
Time Frame: Calculated at each follow-up milestone up to 10 years
|
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
Time Frame: 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
|
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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Aayed R Alqahtani, MD, King Saud University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSGKids10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bariatric Surgery Candidate
-
Unidad Internacional de Cirugia Bariatrica y MetabolicaRecruitingGERD | Bariatric Surgery Candidate | Revisional Bariatric SurgeryVenezuela
-
Unidad Internacional de Cirugia Bariatrica y MetabolicaRecruiting
-
L. van HogezandRijnstate HospitalNot yet recruitingBariatric Surgery Candidate
-
University Hospital, Clermont-FerrandRecruitingBariatric Surgery CandidateFrance
-
Tanta UniversityNot yet recruitingBariatric Surgery Candidate
-
Intuitive SurgicalActive, not recruiting
-
ElsanCemka-EvalWithdrawnBariatric Surgery CandidateFrance
-
Intuitive SurgicalCompletedBariatric Surgery CandidateUnited States
-
University Hospital Inselspital, BerneTerminatedBariatric Surgery CandidateSwitzerland
-
King Saud UniversityUnknownBariatric Surgery CandidateSaudi Arabia
Clinical Trials on Sleeve gastrectomy
-
Hartford HospitalNational Institutes of Health (NIH)Recruiting
-
Centre Hospitalier Departemental VendeeRecruiting
-
Helse FordeNot yet recruitingGastroesophageal RefluxNorway
-
King Saud UniversityNew You Medical CenterCompleted
-
Assistance Publique - Hôpitaux de ParisUnknown
-
GEM Hospital & Research CenterUnknown
-
Umraniye Education and Research HospitalCompletedPostoperative Complications | Bleeding | Postoperative Nausea and VomitingTurkey
-
Laval UniversityUniversité de SherbrookeNot yet recruitingGastroesophageal Reflux | Sleeve Gastrectomy | Bariatric Surgery Complication
-
University Hospital Center of MartiniqueRecruitingObesity-Associated Insulin Resistance | Obesity MorbidMartinique