The Impact of Perioperational Malnutrition on the Cost on Gastroenterological Cancer Patients

Malnutrition Clinical Trial

Official title:

Malnutrition and Its Impact on the Perioperational Hospitalization Cost: A Prospective, Cohort Study on Gastroenterological Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00987883
• Other study ID #: PUMCH-DPEN-09001
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2009
• Last updated: September 30, 2009
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2009
• Source: Peking Union Medical College Hospital
• Contact: Wei Chen, M.D
• Phone: 86 10 65294095
• Email: txchenwei[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroenterological Cancer
• Malnutrition
• Surgical Procedures, Operative

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & 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. — View 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. Epub 2006 May 11. — View Citation

Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. Epub 2007 Dec 3. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost		30 days after operation	No
Secondary	Mortality		30 days after operation	No
Secondary	Infectious morbidity		30 days after operation	No
Secondary	Length of hospitalization		30 days after operation	No