Postoperative Enteral Immunonutrition in Gastric Cancer
NCT ID: NCT02647476
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
98 participants
INTERVENTIONAL
2004-11-30
2015-10-31
Brief Summary
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The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.
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Detailed Description
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Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 or standard enteral nutrition n=54. Following the initial randomization, the patients received either standard nutrition (oligopeptide, low-fat, isocaloric, non-residue diet - Peptisorb, Nutricia) or immunomodulating nutrition (protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study group
Immunomodulating nutrition (Reconvan)
Immunomodulating nutrition (Reconvan)
protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi
Control group
Standard nutrition (Peptisorb)
Standard nutrition (Peptisorb)
oligopeptide, low-fat, isocaloric, non-residue diet
Interventions
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Immunomodulating nutrition (Reconvan)
protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi
Standard nutrition (Peptisorb)
oligopeptide, low-fat, isocaloric, non-residue diet
Eligibility Criteria
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Inclusion Criteria
* elective operation due to gastric cancer
* informed consent signed
* age \> 18 years
* normal nutritional status or mild to moderate malnutrition
Exclusion Criteria
* urgent operation
18 Years
ALL
No
Sponsors
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Jagiellonian University
OTHER
Responsible Party
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Radoslaw Pach, MD, Ph D
Assisstant Professor
Principal Investigators
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Radosław Pach, MD PhD
Role: STUDY_CHAIR
1st Dept. of General Surgery, Jagiellonian University
Locations
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1st Department of General Surgery
Krakow, Malopolska, Poland
Countries
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References
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Scislo L, Pach R, Nowak A, Walewska E, Gadek M, Brandt P, Puto G, Szczepanik AM, Kulig J. The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients - Randomized Clinical Trial. Nutr Cancer. 2018 Apr;70(3):453-459. doi: 10.1080/01635581.2018.1445770. Epub 2018 Mar 13.
Related Links
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LInk to full text of the article with results summary
Other Identifiers
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KBET/91/L/2004
Identifier Type: -
Identifier Source: org_study_id
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