Bariatric Surgery CandidateBariAdoNCT04766801
Adolescents Bariatric Surgery Cohort Survey
An observational study of Bariatric Surgery Candidate and Obesity, Morbid, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, Morbid, Obesity, Adolescent
- What is being tested?
- Laparoscopic adjustable gastric banding
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2008to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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...)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Angers
Angers, Maine Et Loire, 49933
Françoise Schmitt, MD-PhD, 0241354290 ext. +33, FrSchmitt@chu-angers.fr
Régis Coutant, MD-PhD, 0241355655 ext. +33, ReCoutant@chu-angers.fr
About this study
Official title: Evaluation of the Efficiency and Complications Associated With the Surgical Treatment of Obesity by Laparoscopic Adjustable Gastric Banding in an Adolescent Population.
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.
Read the detailed description
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.
- Being tested
- Laparoscopic adjustable gastric banding
- Keywords
- gastric banding, complications, weight loss
- Medical subject headings
- Obesity, Morbid, Pediatric Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic adjustable gastric bandingProcedure or surgery
Weight-loss surgery, with the use of gastric banding
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (8)
Changes of insulin resistance at 2 years
Evaluation of insulin resistance by measure of the HOMA index
Measured: 2 years
Evaluation of dyslipidemia
Evaluation of lipid profile (cholesterol, triglycerides)
Measured: 2 years
Evaluation of liver steatosis
Evaluation of liver steatosis and NAFLD on US exam and liver elastometry
Measured: 2 years
Resolution of comorbidities associated with obesity
Clinical evaluation of the presence/absence of hypertension, sleep apnea, orthopedic disorders and polycystic ovary at two years, compared to Baseline characteristics
Measured: 2 years
Monitoring of psychiatric profile
Clinical evaluation of the presence/absence of psychiatric disorders such as binge eating, depression, etc...
Measured: 2 years
Evaluation of quality of life
Evaluation of obesity-related QOL by the use of the PedsQL scale
Measured: 2 years
Evaluation of cosmetic satisfaction
Evaluation of the patient's level of satisfaction with regards to their surgical scar using the POSAS scale
Measured: 12 months postoperative
Surgical complications
Monitoring of the occurrence of surgical complications and their severity thanks to the Clavien-Dindo scale at each medical consultation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jan 2008
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Françoise Schmitt, MD-PhD, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766801
- Sponsor's protocol ID
- 2007-06
- Acronym
- BariAdo
- Status last verified
- Feb 2021
- First submitted
- 27 Nov 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency and Complications Associated With the Surgical Treatment of Obesity by Laparoscopic Adjustable Gastric Banding in an Adolescent Population.
- ClinicalTrials.gov ID
- NCT04766801
- Acronym / sponsor ID
- BariAdo / 2007-06
- Keywords
- gastric banding, complications, weight loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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...)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic adjustable gastric bandingWeight-loss surgery, with the use of gastric banding | Procedure or surgery | – |
Primary outcome
Change of weight parameters at 2 years compared to preoperative baseline
Time frame: 2 years
Evaluation of weight loss by weight (Kg), body mass index (BMI, Kg.m-2) and excess body weight (EBWL, %) changes
8 secondary outcomes
Changes of insulin resistance at 2 years
Time frame: 2 years
Evaluation of dyslipidemia
Time frame: 2 years
Evaluation of liver steatosis
Time frame: 2 years
Resolution of comorbidities associated with obesity
Time frame: 2 years
Monitoring of psychiatric profile
Time frame: 2 years
Evaluation of quality of life
Time frame: 2 years
Evaluation of cosmetic satisfaction
Time frame: 12 months postoperative
Surgical complications
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Françoise Schmitt, MD-PhD principal investigator
University Hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Obesity, Morbid, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Françoise Schmitt, MD-PhD (0241354290 ext. +33, FrSchmitt@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of weight parameters at 2 years compared to preoperative baseline (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.