Clinical trial NCT04632446: Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis
Official title: Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who underwent elective colorectal surgery consecutively will be included, in which an anastomosis have been performed (neoplastic and non-neoplastic pathology

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Severity of morbidity
timeFrame: 1 year
measure: Severity of mortality
timeFrame: 1 year
Secondary outcomes:
measure: - Compare hospital stay and ICU stay of patients undergoing elective colorectal surgery before and after the improvement program.
timeFrame: 1 year
measure: - Evaluate the difference in the incidence of anastomosis leak after the implementation of the improvement program
timeFrame: 1 year
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: - Hospital Morales Meseguer
Study officials:
affiliation: - Hospital Morales Meseguer
name: Graciela Valero-Navarro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baeza-Murcia M, Valero-Navarro G, Pellicer-Franco E, Soria-Aledo V, Mengual-Ballester M, Garcia-Marin JA, Betoret-Benavente L, Aguayo-Albasini JL. Early diagnosis of anastomotic leakage in colorectal surgery: prospective observational study of the utility of inflammatory markers and determination of pathological levels. Updates Surg. 2021 Dec;73(6):2103-2111. doi: 10.1007/s13304-021-01082-8. Epub 2021 May 20.