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Predictive Value of Procalcitonin, CRP, Drain Fluid Culture, Il-6 and Tnf-α in Anastomotic Leakage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02361918
Recruitment Status : Completed
First Posted : February 12, 2015
Last Update Posted : February 12, 2015
Information provided by (Responsible Party):
Engin HATIPOGLU, Istanbul University

Brief Summary:
Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and TNF-alpha for anastomotic leakage in post-operative period.

Condition or disease Intervention/treatment
Anastomotic Leakage in Colon Surgery Procedure: Colon surgery

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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
Study Start Date : March 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Group/Cohort Intervention/treatment
Anastomotic leakage
Patient had anastomotic leakage
Procedure: Colon surgery
No anastomotic leakage
Patient had no anastomotic leakage
Procedure: Colon surgery

Primary Outcome Measures :
  1. Predictive values of serum CRP, procalcitonin, drain fluid IL-6 and TNF-alpha levels in anastomotic leakage. [ Time Frame: 5 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient had colonic resection

Inclusion Criteria:

  • Patient underwent to colonic resection and had drain

Exclusion Criteria:

  • other patients
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Responsible Party: Engin HATIPOGLU, M.D., Istanbul University Identifier: NCT02361918    
Other Study ID Numbers: CTF-EH0001
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Anastomotic Leak
Postoperative Complications
Pathologic Processes