MalnutritionNCT00987883
The Impact of Perioperational Malnutrition on the Cost on Gastroenterological Cancer Patients
An observational study of Malnutrition and Gastroenterological Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malnutrition, Gastroenterological Cancer, Surgical Procedures, Operative
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalization patient in a teaching hospital
Who may be able to join
- Age 18 or older
- With gastroenterological cancer
- Will receive resectional operation
- Consent informed
Who cannot join
- With severly cardiac, pulmonary, liver or renal disease
- With endocrine or metabolic disease
- With dyslipidemia
- Without consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Wei Chen, M.D, 86 10 65294095, txchenwei@gmail.com
Hua Jiang, M.D, 86 28 86741981, cdjianghua@gmail.com
About this study
Official title: 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.
Read more
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.
- Keywords
- Nutritional Support
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Malnutrition cohort | The patients with undernutrition | |
| Well nourished cohort | Patient that well nourished and without undernutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost
Measured: 30 days after operation
Secondary outcomes (3)
Mortality
Measured: 30 days after operation
Infectious morbidity
Measured: 30 days after operation
Length of hospitalization
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wei Chen, M.D, Study director, Peking Union Medical College HospitalChongmei Lu, M.D, Study chair, Peking Union Medical College HospitalHua Jiang, M.D, Principal investigator, Sichuan Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987883
- Sponsor's protocol ID
- PUMCH-DPEN-09001
- Status last verified
- Sep 2009
- First submitted
- 30 Sep 2009
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14559314Norman 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.
PubMed 18061312Robinson 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.
PubMed 3102782Lochs 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.
PubMed 16697086
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malnutrition and Its Impact on the Perioperational Hospitalization Cost: A Prospective, Cohort Study on Gastroenterological Cancer Patients
- ClinicalTrials.gov ID
- NCT00987883
- Acronym / sponsor ID
- PUMCH-DPEN-09001
- Keywords
- Nutritional Support
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malnutrition cohort | – | –The patients with undernutrition |
| Well nourished cohort | – | –Patient that well nourished and without undernutrition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalization patient in a teaching hospital
Key inclusion criteria (4 listed)
- Age 18 or older
- With gastroenterological cancer
- Will receive resectional operation
- Consent informed
Key exclusion criteria (4 listed)
- With severly cardiac, pulmonary, liver or renal disease
- With endocrine or metabolic disease
- With dyslipidemia
- Without consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cost
Time frame: 30 days after operation
3 secondary outcomes
Mortality
Time frame: 30 days after operation
Infectious morbidity
Time frame: 30 days after operation
Length of hospitalization
Time frame: 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2009.
- Background: PubMed 14559314Correia 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.
- Background: PubMed 18061312Norman 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.
- Background: PubMed 3102782Robinson 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.
- Results publication: PubMed 16697086Lochs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Chen, M.D study director
Peking Union Medical College Hospital
Chongmei Lu, M.D study chair
Peking Union Medical College Hospital
Hua Jiang, M.D principal investigator
Sichuan Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Gastroenterological Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Chen, M.D (86 10 65294095, txchenwei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost (time frame: 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00987883, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2009.