NCT00987883

Brief Summary

Undernutrition is a state marked by energy and/or protein intake deficiency or mal-absorption, and is often described as protein energy malnutrition (PEM). Malnutrition is common in hospitalized patients worldwide. The prevalence of malnutrition in hospitalized patients range from 20% - 50%, depends on the varieties of diseases, health system, population and assessment tools. It is well documented in Western countries that malnutrition affects clinical outcomes negatively. Compared with well-nourished patients, patients with malnutrition stay longer in hospitals and related cost is significantly higher. There is increasing evidence which indicates that appropriate nutrition support (e.g., standardized nutrition screening procedures, delivering nutrients with appropriate path, etc) may improve clinical outcome on malnutrition, along with cost saving. To date, there is no study to document specifically the impact of malnutrition and related nutrition support on the health economics in China. Considering China now is on its way to establish public health security system and a diagnosis-related grouping system, the understanding of the cost effectiveness of nutrition support under the current clinical conditions is crucial. This study aims to investigate the prevalence of perioperational malnutrition in gastroenterological cancer patient, the nutrition support status and related health economic effects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 1, 2009

Status Verified

September 1, 2009

Enrollment Period

8 months

First QC Date

September 30, 2009

Last Update Submit

September 30, 2009

Conditions

MalnutritionGastroenterological CancerSurgical Procedures, Operative

Keywords

Nutritional Support

Outcome Measures

Primary Outcomes (1)

  • Cost

    30 days after operation

Secondary Outcomes (3)

  • Mortality

    30 days after operation

  • Infectious morbidity

    30 days after operation

  • Length of hospitalization

    30 days after operation

Study Arms (2)

Malnutrition cohort

The patients with undernutrition

Well nourished cohort

Patient that well nourished and without undernutrition

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalization patient in a teaching hospital

You may qualify if:

  • Age 18 or older
  • With gastroenterological cancer
  • Will receive resectional operation
  • Consent informed

You may not qualify if:

  • With severly cardiac, pulmonary, liver or renal disease
  • With endocrine or metabolic disease
  • With dyslipidemia
  • Without consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (4)

  • Correia MI, Campos AC; ELAN Cooperative Study. Prevalence of hospital malnutrition in Latin America: the multicenter ELAN study. Nutrition. 2003 Oct;19(10):823-5. doi: 10.1016/s0899-9007(03)00168-0.

    PMID: 14559314BACKGROUND

  • Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. doi: 10.1016/j.clnu.2007.10.007. Epub 2007 Dec 3.

    PMID: 18061312BACKGROUND

  • Robinson G, Goldstein M, Levine GM. Impact of nutritional status on DRG length of stay. JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):49-51. doi: 10.1177/014860718701100149.

    PMID: 3102782BACKGROUND

  • Lochs H, Allison SP, Meier R, Pirlich M, Kondrup J, Schneider S, van den Berghe G, Pichard C. Introductory to the ESPEN Guidelines on Enteral Nutrition: Terminology, definitions and general topics. Clin Nutr. 2006 Apr;25(2):180-6. doi: 10.1016/j.clnu.2006.02.007. Epub 2006 May 11.

    PMID: 16697086RESULT

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Wei Chen, M.D

    Peking Union Medical College Hospital

    STUDY DIRECTOR

  • Chongmei Lu, M.D

    Peking Union Medical College Hospital

    STUDY CHAIR

  • Hua Jiang, M.D

    Sichuan Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Chen, M.D

CONTACT

86 10 65294095txchenwei@gmail.com

Hua Jiang, M.D

CONTACT

86 28 86741981cdjianghua@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 1, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 1, 2009

Record last verified: 2009-09

Locations

CN(1)