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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830907
• Other study ID #: First Hospital of JLU
• Status: Completed
• Phase: Phase 0
• First received: April 10, 2013
• Last updated: April 11, 2013
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of gastric cancer surgery preoperative stage

Exclusion Criteria:

• neoadjuvent chemoradiation

• pregnant

• advanced stage

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Malnutrition
• Stomach Neoplasms

Intervention

Dietary Supplement:
• carbohydrates

• vitamins

Locations

Country	Name	City	State
China	First hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious complication		30 days	Yes
Secondary	Length of hospital stay		30 days	Yes