- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02361918
Predictive Value of Procalcitonin, CRP, Drain Fluid Culture, Il-6 and Tnf-α in Anastomotic Leakage
February 8, 2015 updated by: Engin HATIPOGLU, Istanbul University
Predicting Value of Serum Procalcitonin, C-reactive Protein, and Drain Fluid Culture, Fluid Il-6 and Tnf-α Levels in Anastomotic Leakage Following Rectal Resection
Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and TNF-alpha for anastomotic leakage in post-operative period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To search for a biomarker, which might be able to predict rectal anastomotic leakage before its clinical presentation.
Serum procalcitonin, C-reactive protein, and drain fluid culture, IL-6 and TNF-α levels were evaluated in 50 consecutive patients with rectal cancer who underwent low anterior resection with colorectal anastomosis.
Study Type
Observational
Enrollment (Actual)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patient had colonic resection
Description
Inclusion Criteria:
- Patient underwent to colonic resection and had drain
Exclusion Criteria:
- other patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Anastomotic leakage
Patient had anastomotic leakage
|
|
|
No anastomotic leakage
Patient had no anastomotic leakage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Predictive values of serum CRP, procalcitonin, drain fluid IL-6 and TNF-alpha levels in anastomotic leakage.
Time Frame: 5 day
|
5 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
October 26, 2014
First Submitted That Met QC Criteria
February 8, 2015
First Posted (Estimate)
February 12, 2015
Study Record Updates
Last Update Posted (Estimate)
February 12, 2015
Last Update Submitted That Met QC Criteria
February 8, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTF-EH0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.