PREDICS Study: PCT Reveals Early Dehiscence in Colorectal Surgery (PREDICS)
PREDICS Study: Procalcitonin Reveals Early Dehiscence in Colorectal Surgery
Study Overview
Detailed Description
Anastomotic leak (AL) after colorectal surgery represents a major clinical problem observed in a range from 2 to 7% of patients, rising up to 14% in low colorectal resections, and even to 26% in some older reports.1-3 Enhanced recovery after surgery (ERAS) programs are nowadays proven to reduce postoperative complications in up to 50% of cases, fasten recovery and shorten length of stay.4-5 These fast-track protocols demand very early patient discharge but this might be potentially associated with an increased risk of delayed diagnosis and treatment of AL occurring after patient discharge. Hence, there is a strong need of an additional tool to early diagnose anastomotic leak, prior patient discharge. Serum procalcitonin (PCT), is a 116 amino-acids protein produced by C-cells of the thyroid gland. PCT baseline levels are low (<0.1 ng/ml), but increase significantly in patients with severe bacterial infections. Therefore, PCT levels are used to monitor the course and prognosis of systemic bacterial infections and to tailor the therapeutic interventions more efficiently.6-7 Furthermore, PCT could serve as an early predictive marker for the clinical course of septic complications after abdominal surgery.8-9 The aim of our study is to demonstrate if PCT is a more sensible, specific and reliable biomarker of anastomotic leak (AL) than CRP and WBC and if PCT is < 5 ng/ml in 5th POD might be safely added as an additional criteria of early discharge in ERAS protocols.
All patients undergoing colorectal surgery in our centre, either electively or in emergency setting, are recruited. In all cases white blood count (WBC), C-reactive protein (CRP) and PCT levels are measured in 1st, 3rd and 5th postoperative day (POD). Patients' characteristics (age, sex, renal function, comorbidities), tumor localization, type of operation, intra and postoperative complications and their management, reinterventions, length of hospital stay are recorded. Inclusion criteria are: patients undergoing all different kinds of colorectal surgery (from right colectomies to low anterior resection), either in elective or emergent setting, either for cancer or benign disease (ex diverticular disease) with an anastomosis being performed (ileo-colic, colo-colic, or colo-rectal). Exclusion criteria are: age < 18 years, pregnant women, patients undergoing abdomino-perineal resection or other kinds of colorectal-surgery without an anastomosis being performed. A written informed consent is obtained from all patients. The study is approved by our institution's Ethical Committee.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rome, Italy, 00189
- Sant'Andrea University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all patients undergoing all different kinds of colorectal surgery(from right colectomies to low anterior resection) in our institution, in elective setting, either for cancer or benign disease (ex diverticular disease) with an anastomosis being performed (ileo-colic, colo-colic, or colo-rectal
Exclusion Criteria:
- age < 18 years,
- pregnant women,
- patients undergoing abdomino-perineal resection or other kinds of colorectal-surgery without an anastomosis being performed.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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PCT
Patients undergoing colorectal surgery with an anastomosis performed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Anastomotic leak
Time Frame: within the first 30 days after he operation
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within the first 30 days after he operation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Intra-abdominal infection
Time Frame: within 30 days from the operation
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within 30 days from the operation
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCT-2013
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