Study Calendar Enterostomy Screening Pre Treatment Phase Treatment Phase Sample Clauses

Study Calendar Enterostomy Screening Pre Treatment Phase Treatment Phase. (Refeeding or Control) End of Treatment (Enterostomy Closure) Post Treatment Phase FU 1 3 months 3 months after Entero- stomy Closure) FU 2 6 months 6 months after Entero- stomy Closure) (FU 3 12 months)* 12 months after Entero- stomy Closure) at least 1 week up to 6 weeks at least 3 weeks up to 8 weeks approx. 6 weeks after Enterostomy Creation at least 2 weeks up to 8 weeks Data Assessment daily daily daily Outpatient clinic Outpatient clinic Outpatient clinic Randomization x Demographic data x Informed consent x In-/ Exclusion criteria x Operation protocol x x Body weight x x x x ** x x x Laboratory x *** x *** x *** Refeeding protocol x Nutrition protocol x x Medical history x Adverse events x x x x x x x Time to first bowel movement after enterostomy closure [hours] x *only applicable for patients that are recruited early enough to complete the 12-month follow-up within the 48 months of overall study duration **weight is measured during the subsequent 5 days after reaching the primary endpoint ***every 2 weeks starting at randomization and in cases of pathologic clinical signs (jaundice, acholic stools); Laboratory analysis: During routine blood withdrawal, laboratory analysis for the blood parameters of GGT, ALT, AST, hemoglobin and conjugated bilirubin will be performed every 2 weeks starting from randomization until enterostomy closure. Additionally, in urine, sodium concentration is determined in the same time interval. No additional sample volume is necessary for this study.
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