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

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ClinicalTrials.gov Identifier: NCT00987883
Recruitment Status : Unknown
Verified September 2009 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : October 1, 2009
Last Update Posted : October 1, 2009
Information provided by:

Study Description
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.

Condition or disease
Malnutrition Gastroenterological Cancer Surgical Procedures, Operative

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Malnutrition and Its Impact on the Perioperational Hospitalization Cost: A Prospective, Cohort Study on Gastroenterological Cancer Patients
Study Start Date : April 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Groups and Cohorts

Malnutrition cohort
The patients with undernutrition
Well nourished cohort
Patient that well nourished and without undernutrition

Outcome Measures

Primary Outcome Measures :
  1. Cost [ Time Frame: 30 days after operation ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days after operation ]
  2. Infectious morbidity [ Time Frame: 30 days after operation ]
  3. Length of hospitalization [ Time Frame: 30 days after operation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalization patient in a teaching hospital

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987883

Contact: Wei Chen, M.D 86 10 65294095 txchenwei@gmail.com
Contact: Hua Jiang, M.D 86 28 86741981 cdjianghua@gmail.com

China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Wei Chen, M.D    86 10 65294095    txchenwei@gmail.com   
Contact: Hua Jiang, M.D    86 28 86741981    cdjianghua@gmail.com   
Principal Investigator: Wei Chen, M.D         
Sponsors and Collaborators
Peking Union Medical College Hospital
Study Director: Wei Chen, M.D Peking Union Medical College Hospital
Study Chair: Chongmei Lu, M.D Peking Union Medical College Hospital
Principal Investigator: Hua Jiang, M.D Sichuan Academy of Medical Sciences &Sichuan Provincial People’s Hospital