Cohort study on severe obesity and bariatric surgery outcomes
Cohorte Obésité Bichat LOuis Mourier
Assistance Publique - Hôpitaux de Paris · NCT03538210
This study is trying to understand how bariatric surgery affects severely obese patients by collecting samples from their bodies to find better ways to manage obesity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Colombes, Ile De France) |
| Trial ID | NCT03538210 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to collect and preserve biological samples from severely obese patients undergoing bariatric surgery at the University Hospital. The study focuses on understanding the physiological and pathological consequences of obesity and the effects of bariatric procedures on the gastrointestinal tract. By analyzing samples such as blood, stomach, liver, intestine, and adipose tissue, researchers hope to identify new markers for treatment responses and improve obesity management strategies. The study addresses the need for better therapeutic alternatives to bariatric surgery, which, despite its efficacy, carries risks and complications.
Who should consider this trial
Good fit: Ideal candidates are severely obese individuals with a BMI over 35 kg/m2 who are 18 years or older and are candidates for bariatric surgery.
Not a fit: Patients with psychiatric disorders, organ failure, or chronic life-threatening illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and better management of severe obesity and its complications.
How similar studies have performed: Other studies have shown success in understanding obesity and bariatric surgery outcomes, but this cohort approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * severe obese subject with BMI above35 kg/m2, age above 18 ans who accept to participate * candidate for bariatric surgery according to HAS criteria * who will undergo either sleeve gastrectomy or gastric bypass * or who undergoesa revisional surgery for a complication of bariatric surgery * or who undergoes arevisional sugery fir insufficient weight loss * covered by an health insurance Exclusion Criteria: * psychiatric disease or undertanding disorder * alchool abuse or other addiction * organ failure (including liver, heart or kidney) * chronic life-threatening illness * inflamatory disease or immunosuppressive treatment
Where this trial is running
Colombes, Ile De France
- Hôpital Lousi Mourier (HUPNVS) — Colombes, Ile De France, France (RECRUITING)
Study contacts
- Study coordinator: Séverine LEDOUX, Md, PhD
- Email: severine.ledoux@aphp.fr
- Phone: 147606256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Severe Obesity, Bariatric Surgery, Surgical Failure, obesity, bariatric surgery, gastrointestinal functions, adipose tissu, steatohepatitis