MalnutritionNCT00622999
Effects of Malnutrition on Colon Cancer Patients With Abdominal Surgery
An observational study of Malnutrition and Colon Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The prevalence of malnutrition in patients with colorectal cancer is recorded. We want to find out, if a malnourished patient has more complications after the elective surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Colon Cancer
- How many people
- 186 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2003to Jan 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing colorectal surgery with diagnosed malignity.
Who may be able to join
- Colorectal Carcinoma
- Elective surgery
- Informed consent
Who cannot join
- Survival < 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of malnutrition in patients with colorectal cancer is recorded. We want to find out, if a malnourished patient has more complications after the elective surgery.
Read the detailed description
All patients attending elective colorectal surgery are screened for malnutrition in advance. Their length of stay in the hospital and the complications are recorded.
- Conditions
- Malnutrition, Colon Cancer
- Keywords
- Malnutrition, Colon cancer, Colon surgery, Outcome, Complication rate
- Medical subject headings
- Malnutrition, Colonic Neoplasms
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 |
|---|---|---|
| All | All patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Measured: during stay
Secondary outcomes (1)
Mortality
Measured: during stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJan 2003
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Stefan F Mühlebach, Prof, Study chair, Kantonsspital Aarau, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622999
- Sponsor's protocol ID
- Malnutr_Colon_CH_2007
- Other IDs
- Study ID: 2000/049
- Status last verified
- Mar 2011
- First submitted
- 14 Feb 2008
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Malnutrition on Colon Cancer Patients With Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00622999
- Acronym / sponsor ID
- Malnutr_Colon_CH_2007
- Conditions
- Malnutrition, Colon Cancer
- Keywords
- Malnutrition, Colon cancer, Colon surgery, Outcome, Complication rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 25 Feb 2008 (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.
The prevalence of malnutrition in patients with colorectal cancer is recorded. We want to find out, if a malnourished patient has more complications after the elective surgery.
Detailed description
All patients attending elective colorectal surgery are screened for malnutrition in advance. Their length of stay in the hospital and the complications are recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All | – | –All patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colorectal surgery with diagnosed malignity.
Key inclusion criteria (3 listed)
- Colorectal Carcinoma
- Elective surgery
- Informed consent
Key exclusion criteria (1 listed)
- Survival < 4 weeks
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
Complication rate
Time frame: during stay
1 secondary outcome
Mortality
Time frame: during stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
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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.
Stefan F Mühlebach, Prof study chair
Kantonsspital Aarau, Switzerland
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 Colon Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 11 Mar 2011. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: during stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2011.