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Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04632446
Enrollment
104
Registered
2020-11-17
Start date
2019-01-15
Completion date
2022-12-31
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

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.

Interventions

OTHEREarly diagnosis

Early diagnosis. Upgrade program implementation.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Severity of morbidity1 yearNumber of reoperations, readmissions for infections associated or other medical complications, terminal stomata
Severity of mortality1 yearNumber of related exits

Secondary

MeasureTime frame
- 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 program1 year

Countries

Spain

Contacts

Primary ContactGraciela Valero-Navarro, MD
valerograciela@um.es968360900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026