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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Peking Union Medical College Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT00987883
First received: September 30, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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
Malnutrition
Gastroenterological Cancer
Surgical Procedures, Operative

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Cost [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]
  • Infectious morbidity [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]
  • Length of hospitalization [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Malnutrition cohort
The patients with undernutrition
Well nourished cohort
Patient that well nourished and without undernutrition

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalization patient in a teaching hospital

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987883

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

Locations
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
Investigators
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
  More Information

Publications:
Responsible Party: Wei Chen,M.D, Vice Professor, Assisstant Director of Department of Parenteral and Enteral Nutrition, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT00987883     History of Changes
Other Study ID Numbers: PUMCH-DPEN-09001
Study First Received: September 30, 2009
Last Updated: September 30, 2009
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
Nutritional Support

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 28, 2014