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Trial record 52 of 1006 for:    colon cancer AND resection

Diagnostic Value of C-reactive Protein and White Blood Cell Counts for Early Detection of Inflammatory Complications After Open Resection of Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01221324
Recruitment Status : Completed
First Posted : October 15, 2010
Last Update Posted : February 13, 2012
Sponsor:
Information provided by (Responsible Party):
Ignazio Tarantino, Cantonal Hospital of St. Gallen

Tracking Information
First Submitted Date October 14, 2010
First Posted Date October 15, 2010
Last Update Posted Date February 13, 2012
Study Start Date November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 14, 2010)
postoperative inflammatory complications [ Time Frame: 30 days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01221324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 14, 2010)
Anastomotic leakage [ Time Frame: 60 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Value of C-reactive Protein and White Blood Cell Counts for Early Detection of Inflammatory Complications After Open Resection of Colorectal Cancer
Official Title Not Provided
Brief 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 colorectal cancer.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Given indication for resection of colorectal cancer
Condition Given Indication for Open Resection of Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts Patients after open resection of colorectal cancer
Publications * Warschkow R, Tarantino I, Torzewski M, Näf 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 14, 2010)
1200
Original Estimated Enrollment Same as current
Actual Study Completion Date November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • all patients with resection of colorectal cancer

Exclusion Criteria:

  • lack of measurement of C-reactive protein
  • lack of measurement of white blood cell counts
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Switzerland
 
Administrative Information
NCT Number NCT01221324
Other Study ID Numbers EKSG10/126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ignazio Tarantino, Cantonal Hospital of St. Gallen
Study Sponsor Cantonal Hospital of St. Gallen
Collaborators Not Provided
Investigators
Principal Investigator: Rene Warschkow, MD Cantonal Hospital St. Gallen
PRS Account Cantonal Hospital of St. Gallen
Verification Date February 2012