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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03729505
Eligibility Criteria:
Inclusion Criteria:
* Patients that aged between18 and 65 years.
* American Society of Anesthesiologists (ASA) class I - III.
* Morbidly-obese patients who failed to achieve and maintain a clinically significant weight loss through supervised non-surgical methods for at least 6 months.
* Surgery was conducted as the first line of treatment in case of patients with BMI ≥ 50 kg/m2 (super obese).
Exclusion Criteria:
* Obesity secondary to endocrine disorders.
* History of any previous bariatric procedure.
* Impaired intellectual capacity or major psyciatric disorder.
* Sweet eaters who would not adopt a change of postoperative eating habits.
* Lack of willingness and motivation to embrace postoperative lifestyle changes.
* Substance abuse.
* Pregnancy or expected pregnancy in the following 12 to 18 months.
* Severe gastroesophageal reflux disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03729505
Study Brief:
Protocol Section:
NCT03729505