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Completed

NCT Number: NCT04136704

Long-Term Outcomes of LSG in Pediatric Patients

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

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Key information

Conditions

Obesity, Childhood Bariatric Surgery Candidate Body Weight Cardiovascular Risk Factor Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

King Saud University

Riyadh, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleeve gastrectomy

Procedure

Laparoscopic sleeve gastrectomy

Other names: Vertical Sleeve Gastrectomy

Primary outcomes

  1. 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

  2. Growth

    Time frame: Calculated at each follow-up milestone up to 10 years

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

  3. 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

  4. % 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Collaborators

  • New You Medical Center

Registry information

Official study title

Long-Term Outcomes of Sleeve Gastrectomy in Children and Adolescents

Important dates

Study start
2008
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2019
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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