Common use of Outcome Measures Clause in Contracts

Outcome Measures. Time to full enteral feeds after enterostomy closure (hours) was chosen as the primary outcome parameter because of its clinical relevance representing the influence of MFR on the intestinal autonomy in the course of the disease. The endpoint is highly objective due to the strict and well-defined feeding protocol (see 3.1). In most of the referenced publications postoperative weight gain early after surgery was chosen as the primary outcome parameter. However, body weight is always affected by the shift of body fluids into the third space. Therefore postoperative weight does not always correlate with enteral/ parenteral caloric supplementation as a sign of enteral resorption. For this reason it was not selected as the primary outcome parameter but will be assessed as secondary outcome measure. Secondary outcome measures further include the number of days of postoperative total parenteral nutrition (TPN) and the cholestasis parameters (conjugated bilirubin, GGT, ALT, AST) as indicators for hepatotoxicity of parenteral nutrition. The “time to first bowel movement” (hours) which correlates to the postoperative transanastomotic passage of stool, will be another secondary outcome parameter. A bowel movement consisting of only mucous rather than stool is also considered a bowel movement. Finally, all outcome parameters including possible complications will be assessed during the follow-up 3, 6 and 12 months (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration) after enterostomy closure.