drugset / Trial / NCT00558155
The Impact of Immunostimulating Nutrition on the Outcome of Surgery
RandomizedCrossoverOpen-labelTreatment
Summary
The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205 subjects were randomly assigned into four study groups, standard and immunostimulating, enteral and parenteral. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery.
Timeline
- Start
- 2001-06
- Primary completion
- —
- Completion
- 2005-12
Publications
- Klek S, Sierzega M, Szybinski P, Szczepanek K, Scislo L, Walewska E, Kulig J. Perioperative nutrition in malnourished surgical cancer patients - a prospective, randomized, controlled clinical trial. Clin Nutr. 2011 Dec;30(6):708-13. doi: 10.1016/j.clnu.2011.07.007. Epub 2011 Aug 5.
- Klek S, Kulig J, Sierzega M, Szybinski P, Szczepanek K, Kubisz A, Kowalczyk T, Gach T, Pach R, Szczepanik AM. The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial. Ann Surg. 2008 Aug;248(2):212-20. doi: 10.1097/SLA.0b013e318180a3c1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BUNITROLOL | Small molecule | — | Other |
| Subject | Dipeptiven | Peptide | — | Intravenous |
| Subject | Omegaven | Other / unclassified | — | Intravenous |
| Subject | peptisorb | Unknown | — | Other |
| Background | Addamel | Unknown | — | Intravenous |
| Background | Aminoplasmal | Unknown | — | Intravenous |
| Background | Glucose | Unknown | — | Intravenous |
| Background | Lipofundin MCT/ LCT | Unknown | — | Intravenous |
| Background | Tracutil | Unknown | — | Intravenous |