Laparoscopic Sleeve Gastrectomy in Severely Obese Adolescents: Effects on Metabolism

NCT ID: NCT02594514

Last Updated: 2015-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2014-12-31

Brief Summary

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Severe obesity (SO), defined as BMI≥95th percentile, has increased worldwide among adolescents. American studies estimated that 1.3-2.8% of 12-19-year-old individuals have a BMI \>40 kg/m2 or a BMI \>35 kg/m2 with at least one serious co-morbidity. The immediate and long-term risks associated with SO in adolescents include cardiovascular and metabolic diseases, obstructive sleep apnoea and nonalcoholic fatty liver disease. However, the results of sleeve gastrectomy in adolescents are still uncertain.

Objective and hypotheses: Investigators aimed to assess the long-term safety, efficacy, and cardiovascular risk changes of laparoscopic sleeve gastrectomy in adolescents with SO.

Method: Longitudinal retrospective study of 22 adolescents with SO who underwent laparoscopic sleeve gastrectomy. Clinical and metabolic variables immediately before surgery and after 6, 12, 18 and 24 months were assessed.

Detailed Description

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Conditions

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Obesity Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ages of 14 and 19
* submitted to LSG between 2007 and 2014.
* attended the child obesity clinic of the pediatric endocrinology department of the Instituto da Criança da Universidade de São Paulo (Children's Institute of University of São Paulo).
* received clinical and pharmacological treatment for at least 6 months before surgery and were followed by a multidisciplinary team including a pediatric endocrinologist, a nutritionist, a psychologist and a physical educator.
* BMI \> 40 kg/m2 or BMI \> 35 kg/m2 with comorbidities and failed to achieve significant weight loss (10% of initial weight at 6 months) through clinical treatment.
* Both the patients and their guardians were informed about the risks and benefits of surgery and provided informed consent.

Exclusion Criteria

* it was a retrospective study
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ruth Rocha Franco

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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HCFUMSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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USaoPauloLSG

Identifier Type: -

Identifier Source: org_study_id

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