Adolescents Bariatric Surgery Cohort Survey

NCT ID: NCT04766801

Last Updated: 2021-02-23

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

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Since 2008, in France, certain university hospitals have been eligible to perform bariatric surgery for adolescents. It was therfore possible to define its feasibility, potential complications and specific indications.

This led to recommandations published by Health Authorities (HAS) in 2016. However, it seems imperative to continue monitoring these patients in order to improve their management, especially as the use of these surgical techniques becomes increasingly widespread.

The Angers University Hospital is one of the leading hospitals when it comes bariatric surgery for adolescents through its use of gastric bands.

The aim of this protocol is to update data on how effective this surgery is on weight loss and obesity-associated comorbidities, and to monitor medical, psychological and surgical complications associated with this treatment.

Conditions

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Bariatric Surgery Candidate Obesity, Morbid Obesity, Adolescent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Laparoscopic adjustable gastric banding

Weight-loss surgery, with the use of gastric banding

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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...)

Exclusion Criteria

* 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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Françoise Schmitt, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Angers

Locations

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University Hospital of Angers

Angers, Maine Et Loire, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Françoise Schmitt, MD-PhD

Role: CONTACT

0241354290 ext. +33

Régis Coutant, MD-PhD

Role: CONTACT

0241355655 ext. +33

Facility Contacts

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Françoise Schmitt, MD-PhD

Role: primary

0241354290 ext. +33

Régis Coutant, MD-PhD

Role: backup

0241355655 ext. +33

Other Identifiers

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2007-06

Identifier Type: -

Identifier Source: org_study_id

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