Anastomotic Leakage in Colon SurgeryNCT02361918
Predictive Value of Procalcitonin, CRP, Drain Fluid Culture, Il-6 and Tnf-α in Anastomotic Leakage
An observational study of Anastomotic Leakage in Colon Surgery, run by Istanbul University.
Trial summary
Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and TNF-alpha for anastomotic leakage in post-operative period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anastomotic Leakage in Colon Surgery
- What is being tested?
- Colon surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient had colonic resection
Who may be able to join
- Patient underwent to colonic resection and had drain
Who cannot join
- other patients
About this study
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
Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and TNF-alpha for anastomotic leakage in post-operative period.
Read the 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.
- Conditions
- Anastomotic Leakage in Colon Surgery
- Being tested
- Colon surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Anastomotic leakage | Patient had anastomotic leakage Receives: Procedure: Colon surgery | |
| No anastomotic leakage | Patient had no anastomotic leakage Receives: Procedure: Colon surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive values of serum CRP, procalcitonin, drain fluid IL-6 and TNF-alpha levels in anastomotic leakage.
Measured: 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic Leakage in Colon SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin HATIPOGLU, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361918
- Sponsor's protocol ID
- CTF-EH0001
- Status last verified
- Feb 2015
- First submitted
- 26 Oct 2014
- Last updated
- 12 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02361918
- Acronym / sponsor ID
- CTF-EH0001
- Conditions
- Anastomotic Leakage in Colon Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and TNF-alpha for anastomotic leakage in post-operative period.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anastomotic leakage | – | Procedure: Colon surgeryPatient had anastomotic leakage |
| No anastomotic leakage | – | Procedure: Colon surgeryPatient had no anastomotic leakage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient had colonic resection
Key inclusion criteria (1 listed)
- Patient underwent to colonic resection and had drain
Key exclusion criteria (1 listed)
- other patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colon surgery | Procedure or surgery | Anastomotic leakage, No anastomotic leakage |
Primary outcome
Predictive values of serum CRP, procalcitonin, drain fluid IL-6 and TNF-alpha levels in anastomotic leakage.
Time frame: 5 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
Related trials for Anastomotic Leakage in Colon Surgery
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Recruiting
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Recruiting
Efficacy and Safety of Colorectal Anastomotic Leak Testing
Colorectal Cancer, Leakage Testing
Enrolling by invitationObservational study
Surgical Outcomes in Splenic Flexure Cancers: A Multicenter Comparison of Segmental vs. Extended Hemicolectomy (SPARROW Study)
Colon Cancer, Splenic Flexure Mobilization
Recruiting
PPG vs. ICG in Gastrointestinal Resections
Anastomosis, Perfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leakage in Colon Surgery, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive values of serum CRP, procalcitonin, drain fluid IL-6 and TNF-alpha levels in anastomotic leakage. (time frame: 5 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2015.