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Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

F

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status

Unknown

Conditions

Surgery

Treatments

Other: Early diagnosis

Study type

Observational

Funder types

Other

Identifiers

NCT04632446
IMIB-2020-UPCS

Details and patient eligibility

About

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.

Enrollment

104 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Graciela Valero-Navarro, MD

Data sourced from clinicaltrials.gov

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