NCT02361918

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

October 26, 2014

Last Update Submit

February 8, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Predictive values of serum CRP, procalcitonin, drain fluid IL-6 and TNF-alpha levels in anastomotic leakage.

    5 day

Study Arms (2)

Anastomotic leakage

Patient had anastomotic leakage

Procedure: Colon surgery

No anastomotic leakage

Patient had no anastomotic leakage

Procedure: Colon surgery

Interventions

Colon surgeryPROCEDURE
Anastomotic leakageNo anastomotic leakage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient had colonic resection

You may qualify if:

  • Patient underwent to colonic resection and had drain

You may not qualify if:

  • other patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 26, 2014

First Posted

February 12, 2015

Study Start

March 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

February 12, 2015

Record last verified: 2015-02