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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT01176695
Eligibility Criteria:
Inclusion Criteria:
* Patients considered for open abdominal surgery of moderate severity, e.g.. radical operation for stomach cancer or pancreaticoduodenal surgery
* Male and female patients ≥18 and \<85 years of age
* Indication for total parenteral nutrition therapy: for at least 5 consecutive days after operation
* Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study.
Exclusion Criteria:
* General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid intake and output, inadequate cellular oxygen supply)
* General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency
* Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
* Other
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01176695
Study Brief:
Protocol Section:
NCT01176695