Clinical trial NCT00987883: The Impact of Perioperational Malnutrition on the Cost on Gastroenterological Cancer Patients
Official title: Malnutrition and Its Impact on the Perioperational Hospitalization Cost: A Prospective, Cohort Study on Gastroenterological Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition
Gastroenterological Cancer
Surgical Procedures, Operative
Keywords: Nutritional Support
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2009-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalization patient in a teaching hospital

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Cost
timeFrame: 30 days after operation
Secondary outcomes:
measure: Mortality
timeFrame: 30 days after operation
measure: Infectious morbidity
timeFrame: 30 days after operation
measure: Length of hospitalization
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wei Chen, M.D
role: STUDY_DIRECTOR
affiliation: Peking Union Medical College Hospital
name: Chongmei Lu, M.D
role: STUDY_CHAIR
affiliation: Sichuan Academy of Medical Sciences
name: Hua Jiang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.