Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

Surgery Clinical Trial

Official title:

Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04632446
• Other study ID #: IMIB-2020-UPCS
• Status: Recruiting
• Start date: January 15, 2019
• Est. completion date: December 2022

Study information

• Verified date: October 2020
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: Graciela Valero-Navarro, MD
• Phone: 968360900
• Email: valerograciela[@]um.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Early diagnosis
Early diagnosis. Upgrade program implementation.

Locations

Country	Name	City	State
Spain	- Hospital Morales Meseguer	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of morbidity	Number of reoperations, readmissions for infections associated or other medical complications, terminal stomata	1 year
Primary	Severity of mortality	Number of related exits	1 year
Secondary	- Compare hospital stay and ICU stay of patients undergoing elective colorectal surgery before and after the improvement program.		1 year
Secondary	- Evaluate the difference in the incidence of anastomosis leak after the implementation of the improvement program		1 year