Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

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.

Study Overview

• Status: Unknown
• Conditions: Surgery
• Intervention / Treatment: Other: Early diagnosis

• Study Type: Observational
• Enrollment (Anticipated): 104

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30003
    • Recruiting
    • - Hospital Morales Meseguer
    • Contact: Graciela Valero-Navarro, MD; Phone Number: 968360900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of morbidity	Number of reoperations, readmissions for infections associated or other medical complications, terminal stomata	1 year
Severity of mortality	Number of related exits	1 year

Secondary Outcome Measures

Outcome Measure	Time 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 program	1 year

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Investigators: Principal Investigator: Graciela Valero-Navarro, MD, - Hospital Morales Meseguer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IMIB-2020-UPCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No