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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT03606603
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients after elective major abdominal gastrointestinal surgery \[i.e. elective major GI resections, partial or total, especially for cancer, including: esophagectomy, gastrectomy, enterectomy (small bowel resection), colectomy, hepatectomy, pancreatectomy, resections for gall bladder or bile duct cancer (cholangiocarcinoma)\] with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications\*, with indications for nutritional support
2. Hospitalization on SICU or major surgical ward on the NID
3. Use of EN (nutritional intake provided via tube feeding) and/or PN for at least one day before the NID
4. If patient received oral nutrition (ON) or oral nutrition supplements (ONS) during the observational phase from day -5 to day -2, complete and reliable data of daily caloric and protein intake is available
5. Latest surgical intervention ≤ 10 days before NID
Exclusion Criteria:
1. Patients with burn injuries
2. Patients requiring postsurgical mechanical ventilation and sedation on the NID
3. Patients receiving ON and/or ONS at any quantity on the day before the NID
4. Patients requiring emergency procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03606603
Study Brief:
Protocol Section:
NCT03606603