Long-Term Outcomes of LSG in Pediatric Patients

October 22, 2019 updated by: Aayed Alqahtani, King Saud University

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.

Study Overview

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

Observational

Enrollment (Actual)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Vertical Sleeve Gastrectomy
Sleeve Gastrectomy in Adult Patients
This comparison group will be composed of adult patients who undergo sleeve gastrectomy
Laparoscopic sleeve gastrectomy
Other Names:
  • Vertical Sleeve Gastrectomy

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Aayed R Alqahtani, MD, King Saud University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 22, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • LSGKids10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

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