|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02647476 |
|
Date of registration:
|
01/01/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Postoperative Enteral Immunonutrition in Gastric Cancer
|
|
Scientific title:
|
The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients |
|
Date of first enrolment:
|
November 2004 |
|
Target sample size:
|
98 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02647476 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Poland
| | | | | | | |
|
Contacts
|
|
Name:
|
Radoslaw Pach, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
1st Dept. of General Surgery, Jagiellonian University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- gastric cancer confirmed in histopathological examination
- elective operation due to gastric cancer
- informed consent signed
- age > 18 years
- normal nutritional status or mild to moderate malnutrition
Exclusion Criteria:
- severe malnutrition which required parenteral nutrition
- urgent operation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Gastric Cancer
|
|
Intervention(s)
|
|
Dietary Supplement: Immunomodulating nutrition (Reconvan)
|
|
Dietary Supplement: Standard nutrition (Peptisorb)
|
|
Primary Outcome(s)
|
|
Postoperative complication rate
[Time Frame: 30 days]
|
|
Secondary Outcome(s)
|
|
Overall survival
[Time Frame: 5 years]
|
|
Secondary ID(s)
|
|
KBET/91/L/2004
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|