An observational study in Stoma Ileostomy, Ileostomy - Stoma and Colostomy - Stoma, sponsored by WiGeV Klinik Ottakring. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by WiGeV Klinik Ottakring · Observational
Peroral administration is the preferred way of taking medication. However, the special absorption conditions in ostomy patients are generally not addressed in approval studies and there is also little other literature on this topic. These are usually case reports or studies on individual patients or very small patient collectives.
For medications with measurable clinical parameters, e.g. blood pressure, blood sugar, etc: Blood pressure, blood sugar, etc., these can be used to draw conclusions about any absorption problems. For medications without the possibility of a direct and objective assessment, the assessment is difficult due to the very low level of evidence. Drug groups without a direct physiological measure are e.g: Psy-chotropic drugs (antipsychotics, antidepressants, anxiolytics) and also the novel oral anticoagulants (NOACs).
The clinical trial´s results will answer the following questions:
Recorded and evaluated:
This is the only study on the registry with WiGeV Klinik Ottakring as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Ileostomy and colostomy patients undergoing inpatient/outpatient treatment at Klinik Ottakring
Planned inclusion criteria:
Taking ≥1 of the following active substances since ≥7d:
Exclusion Criteria:
Insurmountable language barrier
Monitoring
Achieved therapeutic serum levels in ostomy patients compared with the therapeutic ranges of the respective pivotal study
During a routine blood draw, an additional 2ml (Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine)or 3.5 ml (NOACs: edoxaban, rivaroxban, apixaban)of blood is taken. In this sample, the drug levels are determined using a validated method ( LC-MS/MS (Psychotropic drugs) or chromogenic test (NOACs)). The drug level \[µg/ml\] determined in this way is compared with the therapeutic target range specified in the respective approval studies.
Time frame: 18 month
Plan to share: No
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