- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00987883
The Impact of Perioperational Malnutrition on the Cost on Gastroenterological Cancer Patients
Malnutrition and Its Impact on the Perioperational Hospitalization Cost: A Prospective, Cohort Study on Gastroenterological Cancer Patients
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.
Studie Overzicht
Toestand
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Werving
- Peking Union Medical College Hospital
-
Contact:
- Wei Chen, M.D
- Telefoonnummer: 86 10 65294095
- E-mail: txchenwei@gmail.com
-
Contact:
- Hua Jiang, M.D
- Telefoonnummer: 86 28 86741981
- E-mail: cdjianghua@gmail.com
-
Hoofdonderzoeker:
- Wei Chen, M.D
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Malnutrition cohort
The patients with undernutrition
|
|
Well nourished cohort
Patient that well nourished and without undernutrition
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Cost
Tijdsspanne: 30 days after operation
|
30 days after operation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Mortality
Tijdsspanne: 30 days after operation
|
30 days after operation
|
|
Infectious morbidity
Tijdsspanne: 30 days after operation
|
30 days after operation
|
|
Length of hospitalization
Tijdsspanne: 30 days after operation
|
30 days after operation
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Wei Chen, M.D, Peking Union Medical College Hospital
- Studie stoel: Chongmei Lu, M.D, Peking Union Medical College Hospital
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PUMCH-DPEN-09001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .