Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

• Conditions: Surgery

• Registration Number: NCT04632446
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-15
• Status Verified: 2020-10
• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-11-11
• Last Update Submitted: 2020-11-11
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Primary Completion: 2020-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of mortality	1 year	Number of related exits
Severity of morbidity	1 year	Number of reoperations, readmissions for infections associated or other medical complications, terminal stomata

Secondary Outcome Measures

Name	Time	Method
- 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

Trial Locations

Locations (1)

- Hospital Morales Meseguer; 🇪🇸 Murcia, Spain