NCT01830907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

1.1 years

First QC Date

April 10, 2013

Last Update Submit

April 11, 2013

Conditions

MalnutritionGastric Cancer

Keywords

MalnutritionGastric cancerpreoperative nutrition

Outcome Measures

Primary Outcomes (1)

  • Infectious complication

    30 days

Secondary Outcomes (1)

  • Length of hospital stay

    30 days

Study Arms (2)

Enteral

ACTIVE COMPARATOR

Enteral nutrition composed of carbohydrates and vitamins

Dietary Supplement: carbohydratesDietary Supplement: vitamins

Parenteral

ACTIVE COMPARATOR
Dietary Supplement: carbohydratesDietary Supplement: vitamins

Interventions

carbohydratesDIETARY_SUPPLEMENT
EnteralParenteral
vitaminsDIETARY_SUPPLEMENT
EnteralParenteral

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of gastric cancer surgery preoperative stage

You may not qualify if:

  • neoadjuvent chemoradiation
  • pregnant
  • advanced stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Related 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.

    PMID: 22549764BACKGROUND

MeSH Terms

Conditions

MalnutritionStomach Neoplasms

Interventions

CarbohydratesVitamins

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

MicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 12, 2013

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

April 12, 2013

Record last verified: 2013-04

Locations

CN(1)