Massive Obesity and Surgery: Referral Centre Cohort for Medical and Surgical Inpatient Treatment for Massive Obesity
FRESH-PEF60103-en
Arnaud BASDEVANT
Massive Obesity and Surgery: Referral Centre Cohort for Medical and Surgical Inpatient Treatment for Massive Obesity
OBEMASCH
FRESH-PEF60103-en
60103
FRESH-PEF60103
Arnaud BASDEVANT
Karine CLEMENT
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)
Epidemiology France Portal (PEF)
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Karine;CLEMENT
medical assessment
determinants
somatic
biological
psychological
metabolic
social
consequences
cardiovascular
respiratory
complications
deficiencies
oral dental condition
nutritional assessment
evaluation
health events
Endocrinology
Behavioral determinants: Eating habits
Biological determinants: Genetic predisposition
Healthcare system determinants: Use of care
Behavioral determinants
Biological determinants
Healthcare system determinants
General objective: to monitor variations in weight and body composition as well as metabolic, cardiovascular and pulmonary comorbidities introduced by surgery for obesity. Secondary objective: to study tissue, vitamin, cellular and systemic physiopathological changes (metabolic and inflammatory phenomena, insulin resistance) induced by bariatric surgery.
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France
Ile-de-France
Individuals
Patients population
Male
Female
Young Adult (19 to 24 years)
Adult (25 to 44 years)
Middle Aged (45 to 64 years)
Patients diagnosed as massively obese (BMI greater than 40 kg/m²) or severely obese (BMI between 35-40 kg/m²) with comorbidities (diabetes, sleep apnoea syndrome, arterial hypertension etc.) and whose weight is stable or has increased over a 3 month period (weight change of at least 2 kg) preceding gastric surgery (bypass, sleeves, ring), after a decision made by a multi-disciplinary team and medical follow-up for at least one year. Between 18 and 55 years of age.
Clinical data
Participant-reported health data
Biological data
Paraclinical data (non-biological) : Imaging
Request for consistency after data is processed electronically. Missing data is managed by returning to source record or third party. Physicians contacted again for follow-up visits Subjects contacted again for follow-up visits Internal quality audits carried out once per month as part of the CRC An APHP audit was carried out in 2007 on the database from 2005 Other quality procedure(s): a systematic return and verification of source data is carried out by the researcher with contact from physician collecting the clinical and laboratory data during data analysis as part of the studies conducted by the INSERM team. Aberrant laboratory values are verified from source data Patients are informed of the use of their data
Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception
Other
Through organizations (health services or institutions
schools
businesses
etc.)
< 500 individuals
Self-administered questionnaire
Interview with the participant (including clinical)
Observational Study
Observational Study
Cohort study
479 (depuis/since 2002)
Unknown
Restricted access
Data may be used by academic teams. Data may be used by industrial teams.
Access conditions for academic teams: several hospitals and research teams are interested in kinetic evolution of comorbidities using the bypass model; many specialities are involved and several collaborations are taking place, such as: - Bone characteristics study (bone remodelling factors) Dr. Richette's rheumatology department hospital team, Lariboisiere - post- and pre-operative masticatory characteristics study (Bretonneau hospital, Dr. Miller) - intestinal flora study (Dr. Joel Dore and Dr. Corthier) or within the European programme framework (ADAPT, HEPADIP) All studies are subject to CPP (Ethics Committee) review and specific funding. Bioresource usage is subject to MTA (material transfer agreement) with APHP. Access conditions for industrial teams : Specific APHP or INSERM industry contracts A contract was established in 2006 with Berlin Metabomics to investigate metabolic evolution
Access on specific project only