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:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT03610256
Eligibility Criteria:
Inclusion Criteria:
* Patient aged between 18 and 65 years old,
* Morbid obesity with BMI ≥40 kg/m2 or BMI ≥35 kg/m2 associated with one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis)
* Patient who has benefited from an upper GI endoscopy with biopsies to look for Helicobacter pylori , within the 12 months before surgery,
* Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for SADI-S or RYGB as a primary surgery or after failure of sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (EWL% \<50), or as weight regain (+ 20%)).
* Patient who understands and accepts the need for a long term follow-up,
* Patient who agrees to be included in the study and who signs the informed consent form,
* Patient affiliated with a healthcare insurance plan.
Exclusion Criteria:
* History of previous bariatric surgery, other than a sleeve gastrectomy,
* Presence of a severe and evolutive life threatening pathology, unrelated to obesity,
* History of type 1 diabete,
* History of chronic inflammatory bowel disease,
* Pregnancy or desire to be pregnant during the study,
* Presence of Helicobacter pylori resistant to medical treatment,
* Presence of a unhealed gastro-duodenal ulcer or diagnosed less than 2 months previously,
* Mentally unbalanced patients, under supervision or guardianship,
* Patient who does not understand French/ is unable to give consent,
* Patient not affiliated to a French or European healthcare insurance,
* Patient who has already been included in a trial which has a conflict of interests with the present study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03610256
Study Brief:
Protocol Section:
NCT03610256