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Clinical Trials/NCT04632446
NCT04632446
Unknown
Not Applicable

Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia1 site in 1 country104 target enrollmentStarted: January 15, 2019Last updated:
ConditionsSurgery

Overview

Phase
Not Applicable
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Enrollment
104
Locations
1
Primary Endpoint
Severity of mortality

Overview

Brief Summary

The anastomotic leak (AL) is a very serious complication in colorectal surgery not only because of its severity but its frequency. Other facet for study, besides the risk factor and prevention, is the AL early diagnostic, due to minimize the clinical consequences and severity; and avoid the failure-to-recue. Several studies analyze the Creactive protein (CRP) and Procalcitonine (PCT) usefulness in AL predictor before the clinical signs appear.

At a prospective observational study carry on our center, it concluded that CRP at 3rd day after surgery over 15mg/dl was a very important AL predictor, even before the clinical changes appear. The aim of this study is minimize the severity complications and the mortality due to AL appears. The aim of this study is minimize the severity complications and the mortality due to AL by means of introduces an upgrade program in which a CT scan will be conduct in all the patients with high CRP levels at 3rd, 4th or 5th postoperative day, with the goal to know the AL early and make all the therapeutic step to minimize the consequences.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients over 18 years of age.
  • Patients undergoing elective colorectal surgery due to neoplastic or non-neoplastic etiology.
  • Patients with an anastomosis performed in the surgical act.
  • Signed informed consent.

Exclusion Criteria

  • Patients who require transfer to another center.
  • Patients with fatal evolution: those who require urgent reoperation for an inarverted perforation, early leakage of anastomosis or death before the third postoperative day.

Outcomes

Primary Outcomes

Severity of mortality

Time Frame: 1 year

Number of related exits

Severity of morbidity

Time Frame: 1 year

Number of reoperations, readmissions for infections associated or other medical complications, terminal stomata

Secondary Outcomes

  • - Compare hospital stay and ICU stay of patients undergoing elective colorectal surgery before and after the improvement program.(1 year)
  • - Evaluate the difference in the incidence of anastomosis leak after the implementation of the improvement program(1 year)

Investigators

Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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