Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02290418
Eligibility Criteria:
Inclusion Criteria:
* Severe Obesity: BMI ≥ 40 and ≤ 50 or (BMI ≥ 35 and \< 40 and type 2 diabetes or metabolic syndrome)
* Inadequate results of Attempts to loose weight by Conservative means
* Ability to understand the nature of the procedure and willing to follow postoperative routine lifestyle and checkups
* no contraindication for bariatric surgery on psychological assessment
* no contraindication for general anesthesia
* consent for both variants of gastric bypass surgery
* consent to participate in a study with randomized design
Exclusion Criteria:
* prior bariatric surgery of any kind
* gravidity or recent (\<1 year) labour
* drug or alcohol abuse
* symptomatic Gastro Esophageal Reflux Disease (GERD)
* hiatal hernia, \> 3cm
* esophagitis, ≥ 2. grade
* active smoker
* chronic renal disease, stage ≥ 3
* patient immobility
* surgery not covered by universal insurance in Czech rep. (i.e. international patients)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02290418
Study Brief:
Protocol Section:
NCT02290418