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Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002

Primary Purpose

Malnutrition, Gastric Cancer

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
carbohydrates
vitamins
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Malnutrition, Gastric cancer, preoperative nutrition

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of gastric cancer surgery preoperative stage

Exclusion Criteria:

  • neoadjuvent chemoradiation
  • pregnant
  • advanced stage

Sites / Locations

  • First hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enteral

Parenteral

Arm Description

Enteral nutrition composed of carbohydrates and vitamins

Outcomes

Primary Outcome Measures

Infectious complication

Secondary Outcome Measures

Length of hospital stay

Full Information

First Posted
April 10, 2013
Last Updated
April 11, 2013
Sponsor
The First Hospital of Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT01830907
Brief Title
Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002
Official Title
Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002- A Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Hospital of Jilin University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients at nutritional risk. The primary endpoint was the complication rate and the second endpoint was the length of stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Gastric Cancer
Keywords
Malnutrition, Gastric cancer, preoperative nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enteral
Arm Type
Active Comparator
Arm Description
Enteral nutrition composed of carbohydrates and vitamins
Arm Title
Parenteral
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
carbohydrates
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamins
Primary Outcome Measure Information:
Title
Infectious complication
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of gastric cancer surgery preoperative stage Exclusion Criteria: neoadjuvent chemoradiation pregnant advanced stage
Facility Information:
Facility Name
First hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22549764
Citation
van Stijn MF, Korkic-Halilovic I, Bakker MS, van der Ploeg T, van Leeuwen PA, Houdijk AP. Preoperative nutrition status and postoperative outcome in elderly general surgery patients: a systematic review. JPEN J Parenter Enteral Nutr. 2013 Jan;37(1):37-43. doi: 10.1177/0148607112445900. Epub 2012 May 1.
Results Reference
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Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002

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