The Impact of Immunostimulating Nutrition on the Outcome of Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer Pancreatic Cancer |
Drug: peptisorb Drug: Stresson Drug: Parenteral nutrition Drug: Omegaven, Dipeptiven |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Title: The Impact of Immunostimulating Nutrition on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial. |
- During the postoperative period, all patients were observed for both surgical and non-surgical complications [ Time Frame: 52 months ]
- The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay. [ Time Frame: 52 months ]
| Enrollment: | 214 |
| Study Start Date: | June 2001 |
| Study Completion Date: | December 2005 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SEN
standard enteral nutrition
|
Drug: peptisorb
standard isocaloric eteral diet (1 ml = 1 kcal)
|
|
Experimental: IMEN
immunostimulating enteral nutrition
|
Drug: Stresson
Oligopeptic, enteral diet (1 ml=1.25 kcal)
|
|
Experimental: SPN
standard parenteral nutrition
|
Drug: Parenteral nutrition
Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel
|
|
Experimental: IMPN
immunostimulating parenteral nutrition
|
Drug: Omegaven, Dipeptiven
Immunostimulating components: Omegaven (omega-3-fatty acids) and Dipeptiven (Glutamine Arginine) Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel
|
Detailed Description:
All patients qualified between June 2001 and December 2005 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. Additional eligibility criteria included: age between 18 and 80 years, Karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. Patients requiring preoperative nutritional support, as well as those with disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery. Therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay.
After completing tumor resection, patients who met the eligibility criteria were intraoperatively assigned to either of the treatment groups using sealed envelopes containing computer-generated allocation numbers. The following groups were generated: standard enteral nutrition (SEN), immunostimulating enteral nutrition (IMEN), standard parenteral nutrition (SPN), and immunostimulating parenteral nutrition (IMPN). The study was carried out following the international ethical recommendations stated in the Declaration of Helsinki.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- resectable gastric or pancreatic cancer
- age between 18 and 80 years,
- Karnofsky performance status score of 80 or more,
- adequate organ function
Exclusion Criteria:
- unresectable gastric or pancreatic cancer
- patients requiring preoperative nutritional support,
- disseminated tumors,
- serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5),
- renal or liver failure were excluded
Contacts and Locations| Poland | |
| 1st Department of General Surgery | |
| Krakow, Poland, 30-798 | |
| Principal Investigator: | Stanislaw Klek, PhD, MD | Jagiellonian University 1 Dept Surgery |
More Information
No publications provided by Jagiellonian University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00558155 History of Changes |
| Other Study ID Numbers: | 1st Dept Surg |
| Study First Received: | November 9, 2007 |
| Last Updated: | November 13, 2007 |
| Health Authority: | Poland: Ministry of Health |
Keywords provided by Jagiellonian University:
|
immunonutrition enteral nutrition parenteral nutrition surgery |
Additional relevant MeSH terms:
|
Stomach Neoplasms Pancreatic Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013