Anastomotic LeakPREDICSNCT01817647
PREDICS Study: PCT Reveals Early Dehiscence in Colorectal Surgery
An observational study of Anastomotic Leak, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak
- What is being tested?
- Colorectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 504 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to Sep 2014
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing all different kinds of colorectal surgery (from right colectomies to low anterior resection), in elective setting, either for cancer or benign disease (ex diverticular disease) with an anastomosis being performed (ileo-colic, colo-colic, or colo-rectal)
Who may be able to join
- 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
Who cannot join
- age < 18 years,
- pregnant women,
- patients undergoing abdomino-perineal resection or other kinds of colorectal-surgery without an anastomosis being performed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREDICS Study: Procalcitonin Reveals Early Dehiscence in Colorectal Surgery
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.
Read the 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.
- Conditions
- Anastomotic Leak
- Being tested
- Colorectal surgery
- Keywords
- AL, Enhanced recovery after surgery (ERAS), reduce postoperative complications, increased risk of delayed diagnosis and treatment of AL, diagnose anastomotic leak
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PCT | Patients undergoing colorectal surgery with an anastomosis performed Receives: Procedure: Colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak
Measured: within the first 30 days after he operation
Secondary outcomes (1)
Intra-abdominal infection
Measured: within 30 days from the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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 only
- Time perspective
- Prospective
- Enrolment
- 504 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Giaccaglia, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817647
- Sponsor's protocol ID
- PCT-2013
- Acronym
- PREDICS
- Status last verified
- Sep 2014
- First submitted
- 20 Mar 2013
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Giaccaglia V, Salvi PF, Antonelli MS, Nigri G, Pirozzi F, Casagranda B, Giacca M, Corcione F, de Manzini N, Balducci G, Ramacciato G. Procalcitonin Reveals Early Dehiscence in Colorectal Surgery: The PREDICS Study. Ann Surg. 2016 May;263(5):967-72. doi: 10.1097/SLA.0000000000001365.
PubMed 26528879
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICS Study: Procalcitonin Reveals Early Dehiscence in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01817647
- Acronym / sponsor ID
- PREDICS / PCT-2013
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Mar 2013 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCT | – | Procedure: Colorectal surgeryPatients undergoing colorectal surgery with an anastomosis performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing all different kinds of colorectal surgery (from right colectomies to low anterior resection), in elective setting, either for cancer or benign disease (ex diverticular disease) with an anastomosis being performed (ileo-colic, colo-colic, or colo-rectal)
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- age < 18 years,
- pregnant women,
- patients undergoing abdomino-perineal resection or other kinds of colorectal-surgery without an anastomosis being performed.
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 |
|---|---|---|
| Colorectal surgery | Procedure or surgery | PCT |
Primary outcome
Anastomotic leak
Time frame: within the first 30 days after he operation
1 secondary outcome
Intra-abdominal infection
Time frame: within 30 days from the operation
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 29 Sep 2014.
- Derived from this study: PubMed 26528879Giaccaglia V, Salvi PF, Antonelli MS, Nigri G, Pirozzi F, Casagranda B, Giacca M, Corcione F, de Manzini N, Balducci G, Ramacciato G. Procalcitonin Reveals Early Dehiscence in Colorectal Surgery: The PREDICS Study. Ann Surg. 2016 May;263(5):967-72. doi: 10.1097/SLA.0000000000001365.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak, run by University of Roma La Sapienza at 1 site in Italy.
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 3 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 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Anastomotic leak (time frame: within the first 30 days after he operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817647, which also lists 1 linked publication.
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 29 Sep 2014.