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PREDICS Study: PCT Reveals Early Dehiscence in Colorectal Surgery

PREDICS Study: Procalcitonin Reveals Early Dehiscence in Colorectal Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01817647
Acronym
PREDICS
Enrollment
504
Registered
2013-03-25
Start date
2012-12-31
Completion date
2014-09-30
Last updated
2014-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak

Keywords

AL, Enhanced recovery after surgery (ERAS), reduce postoperative complications, increased risk of delayed diagnosis and treatment of AL, diagnose anastomotic leak

Brief summary

Procalcitonin (PCT) is a biomarker used to monitor serious bacterial infections and guide antibiotic therapy. Anastomotic leak (AL) after colorectal surgery is a severe complication associated with relevant short and long-term sequelae. The aim of our study is to assess the predictive value of PCT level for early diagnosis of anastomotic leak after colorectal surgery.

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.

Interventions

PROCEDUREColorectal surgery

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Anastomotic leakwithin the first 30 days after he operation

Secondary

MeasureTime frame
Intra-abdominal infectionwithin 30 days from the operation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026