NCT01817647

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
504

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

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

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 29, 2014

Status Verified

September 1, 2014

Enrollment Period

1.8 years

First QC Date

March 20, 2013

Last Update Submit

September 26, 2014

Conditions

Anastomotic Leak

Keywords

ALEnhanced recovery after surgery (ERAS)reduce postoperative complicationsincreased risk of delayed diagnosis and treatment of ALdiagnose anastomotic leak

Outcome Measures

Primary Outcomes (1)

  • Anastomotic leak

    within the first 30 days after he operation

Secondary Outcomes (1)

  • Intra-abdominal infection

    within 30 days from the operation

Study Arms (1)

PCT

Patients undergoing colorectal surgery with an anastomosis performed

Procedure: Colorectal surgery

Interventions

Colorectal surgeryPROCEDURE
PCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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)

You may qualify if:

  • 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

You may not qualify if:

  • age \< 18 years,
  • pregnant women,
  • patients undergoing abdomino-perineal resection or other kinds of colorectal-surgery without an anastomosis being performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sant'Andrea University Hospital

Rome, 00189, Italy

Location

Related Publications (1)

  • 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.

    PMID: 26528879DERIVED

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 25, 2013

Study Start

December 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 29, 2014

Record last verified: 2014-09

Locations

IT(1)