Clinical Trials Directory

Trials / Completed

CompletedNCT02647476

Postoperative Enteral Immunonutrition in Gastric Cancer

The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
98 (actual)
Sponsor
Jagiellonian University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Detailed description

Treatment of gastric cancer often requires major surgery and carries the risk of postoperative complications and fatal outcomes. Mortality rates after gastrectomy due to gastric cancer have been reported as 2-5%, while the incidence of postoperative complications was 10 to over 40%. 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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTImmunomodulating nutrition (Reconvan)protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi
DIETARY_SUPPLEMENTStandard nutrition (Peptisorb)oligopeptide, low-fat, isocaloric, non-residue diet

Timeline

Start date
2004-11-01
Primary completion
2010-12-01
Completion
2015-10-01
First posted
2016-01-06
Last updated
2019-02-27

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT02647476. Inclusion in this directory is not an endorsement.