Given Indication for Open Resection of Colorectal CancerNCT01221324
Diagnostic Value of C-reactive Protein and White Blood Cell Counts for Early Detection of Inflammatory Complications After Open Resection of Colorectal Cancer
An observational study of Given Indication for Open Resection of Colorectal Cancer, run by Cantonal Hospital of St. Gallen.
Trial summary
Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive protein (CRP) and white blood cell counts (WBC) in the postoperative course. The aim of this study was to evaluate the diagnostic accuracy of CRP and WBC for postoperative inflammatory complications after open resection of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Given Indication for Open Resection of Colorectal Cancer
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Nov 2010
- 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: Given indication for resection of colorectal cancer
Who may be able to join
- all patients with resection of colorectal cancer
Who cannot join
- lack of measurement of C-reactive protein
- lack of measurement of white blood cell counts
About this study
Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive protein (CRP) and white blood cell counts (WBC) in the postoperative course. The aim of this study was to evaluate the diagnostic accuracy of CRP and WBC for postoperative inflammatory complications after open resection of colorectal cancer.
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 |
|---|---|---|
| Patients after open resection of colorectal cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative inflammatory complications
Measured: 30 days
Secondary outcomes (1)
Anastomotic leakage
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Given Indication for Open Resection of Colorectal CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignazio Tarantino, Cantonal Hospital of St. Gallen
- Investigators
- Rene Warschkow, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221324
- Sponsor's protocol ID
- EKSG10/126
- Status last verified
- Feb 2012
- First submitted
- 14 Oct 2010
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Warschkow R, Tarantino I, Torzewski M, Naf F, Lange J, Steffen T. Diagnostic accuracy of C-reactive protein and white blood cell counts in the early detection of inflammatory complications after open resection of colorectal cancer: a retrospective study of 1,187 patients. Int J Colorectal Dis. 2011 Nov;26(11):1405-13. doi: 10.1007/s00384-011-1262-0. Epub 2011 Jun 24.
PubMed 21701807
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of C-reactive Protein and White Blood Cell Counts for Early Detection of Inflammatory Complications After Open Resection of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01221324
- Acronym / sponsor ID
- EKSG10/126
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 15 Oct 2010 (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.
Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive protein (CRP) and white blood cell counts (WBC) in the postoperative course. The aim of this study was to evaluate the diagnostic accuracy of CRP and WBC for postoperative inflammatory complications after open resection of colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after open resection of colorectal cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Given indication for resection of colorectal cancer
Key inclusion criteria (1 listed)
- all patients with resection of colorectal cancer
Key exclusion criteria (2 listed)
- lack of measurement of C-reactive protein
- lack of measurement of white blood cell counts
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
postoperative inflammatory complications
Time frame: 30 days
1 secondary outcome
Anastomotic leakage
Time frame: 60 days
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 13 Feb 2012.
- Background: PubMed 21701807Warschkow R, Tarantino I, Torzewski M, Naf F, Lange J, Steffen T. Diagnostic accuracy of C-reactive protein and white blood cell counts in the early detection of inflammatory complications after open resection of colorectal cancer: a retrospective study of 1,187 patients. Int J Colorectal Dis. 2011 Nov;26(11):1405-13. doi: 10.1007/s00384-011-1262-0. Epub 2011 Jun 24.
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.
Rene Warschkow, MD principal investigator
Cantonal Hospital of St. Gallen
Questions about this trial
What is this clinical trial studying?
An observational study of Given Indication for Open Resection of Colorectal Cancer, run by Cantonal Hospital of St. Gallen.
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 1 inclusion and 2 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 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
postoperative inflammatory complications (time frame: 30 days). 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 NCT01221324, which also lists 1 linked publication.
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 13 Feb 2012.