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
Procedure: Colon surgery
No anastomotic leakage
Patient had no anastomotic leakage
Procedure: Colon surgery

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

Istanbul University

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.

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