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Clinical Trials/NCT01830907
NCT01830907CompletedPhase 1

Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002- A Prospective, Randomized Clinical Trial

The First Hospital of Jilin University1 site in 1 country460 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
460
Locations
1
Primary Endpoint
Infectious complication

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •clinical diagnosis of gastric cancer surgery preoperative stage

Exclusion Criteria

  • •neoadjuvent chemoradiation
  • •advanced stage

Arms & Interventions

Enteral

Active Comparator

Enteral nutrition composed of carbohydrates and vitamins

Intervention: carbohydrates (Dietary Supplement)

Enteral

Active Comparator

Enteral nutrition composed of carbohydrates and vitamins

Intervention: vitamins (Dietary Supplement)

Parenteral

Active Comparator

Intervention: carbohydrates (Dietary Supplement)

Parenteral

Active Comparator

Intervention: vitamins (Dietary Supplement)

Outcomes

Primary Outcomes

Infectious complication

Time Frame: 30 days

Secondary Outcomes

  • Length of hospital stay(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Punyaram Kharbuja

MD

The First Hospital of Jilin University

Study Sites (1)

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