Adolescents Bariatric Surgery Cohort Survey
BariAdo
Evaluation of the Efficiency and Complications Associated With the Surgical Treatment of Obesity by Laparoscopic Adjustable Gastric Banding in an Adolescent Population.
1 other identifier
observational
100
1 country
1
Brief Summary
Obesity affects 3%-4% of the pediatric population and leads to cardiac mortality during adult life. Bariatric surgery is the best treatment for weight loss and preventing obesity associated comorbidities in adults, but its applications and safety are yet to be defined for adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 27, 2020
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
ExpectedFebruary 23, 2021
February 1, 2021
13.8 years
November 27, 2020
February 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of weight parameters at 2 years compared to preoperative baseline
Evaluation of weight loss by weight (Kg), body mass index (BMI, Kg.m-2) and excess body weight (EBWL, %) changes
2 years
Secondary Outcomes (8)
Changes of insulin resistance at 2 years
2 years
Evaluation of dyslipidemia
2 years
Evaluation of liver steatosis
2 years
Resolution of comorbidities associated with obesity
2 years
Monitoring of psychiatric profile
2 years
- +3 more secondary outcomes
Interventions
Weight-loss surgery, with the use of gastric banding
Eligibility Criteria
Pediatric patients treated in our hospital for morbid obesity (BMI \>= 35 Kg.M-2) through different programs with lifestyle and nutritional interventions and, for those who requested it, the possibility of bariatric surgery.
You may qualify if:
- Patients aged 14-20 years of age and asking for bariatric surgery
- BMI \>= 40 Kg.m-2 or \>= 35 Kg.m-2 with major obesity-related comorbidities (hypertension, diabetes, sleep apnea, etc...)
You may not qualify if:
- An unstable psychiatric disorder
- Bariatric surgery anesthesic contraindications
- Having not completed a minimum of six months of the pre operative program
- Lack of consent from the patient or the patient's relatives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Angers
Angers, Maine Et Loire, 49933, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Françoise Schmitt, MD-PhD
University Hospital of Angers
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2020
First Posted
February 23, 2021
Study Start
January 1, 2008
Primary Completion
October 31, 2021
Study Completion (Estimated)
December 31, 2030
Last Updated
February 23, 2021
Record last verified: 2021-02