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 @ 12:23 PM
Ignite Modification Date:
2025-12-24 @ 12:23 PM
NCT ID:
NCT03114761
Eligibility Criteria:
Inclusion Criteria:
* The patient should have underwent laparoscopic RYGB surgery (standard procedure with closing of mesenteric openings) at least half a year earlier;
* The patient should have abdominal pain, at least three days in a row;
* The patient should be highly suspected for internal herniation by their doctor (based on weight loss, location of pain, intervals between pain, relation to food intake).
Exclusion Criteria:
* The patient has an age below 18;
* The patient is incompetent to decide;
* The patient is pregnant or gives breast feeding;
* The patient is in emergency setting and requires imminent surgery;
* The patient has other known abdominal pathology or prior large abdominal surgery;
* The patient has had surgery for internal herniation previously;
* The patient has had earlier surgery involving the RYGB, such as distalisation;
* One or both scans have insufficient scan quality;
* The patient will not be subjected to diagnostic laparoscopic surgery (e.g. pain-free patients);
* The patient has a contra-indication for the administration of oral or IV contrast (Xenetide 300mg/ml).:
* Thyrotoxicose
* Overgevoeligheid/allergisch voor Xenetix of in het verleden een allergische reactie op jodiumhoudend contrast
* Treatment with NSAID's, diuretica or aminoglycosiden that cannot be stopped 24 hours before and after the CT
* Treatment with cisplatina less than six weeks before CT
* M.Kahler or M. Waldenstrom
* Kidneyfunction (GFS) \< 60
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03114761
Study Brief:
Protocol Section:
NCT03114761