The Effect of the EndoBarrier Device: A 3-year follow-up of a randomized clinical trial.
Completed
- Conditions
- Obesity1000301810017998
- Registration Number
- NL-OMON41836
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 29
Inclusion Criteria
1) Patients who were previously enrolled in the randomized clinical EndoBarrier procedure trial at the MUMC or the Atrium Medical Centre Heerlen regardless of their excess weight loss
2) Patients who have a follow up of at least 3 years.
3) Signed informed consent
Exclusion Criteria
1) Post-EndoBarrier conventional bariatric surgery
2) Patients who were lost to follow-up during the previous conducted Endobarrier clinical trial
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The percentage of Excessive weight loss to assess the impact of the EndoBarrier<br /><br>on body weight three years after explantation</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the Effectiveness of the EndoBarrier device three years after<br /><br>explantation on lowering risk factors associated with morbid obesity.<br /><br>- To assess long-term patient satisfaction after the EndoBarrier device.<br /><br>- To assess long-term quality of life in patients after the EndoBarrier device.<br /><br>- To assess the concentration of fibroblast growth factor 19 (FGF19), total<br /><br>bile salts and bile salts composition in human plasma samples measured using<br /><br>immunological (ELISA) and enzymatic assays, respectively. </p><br>