Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

November 11, 2020 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of morbidity
Time Frame: 1 year
Number of reoperations, readmissions for infections associated or other medical complications, terminal stomata
1 year
Severity of mortality
Time Frame: 1 year
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.
Time Frame: 1 year
1 year
- Evaluate the difference in the incidence of anastomosis leak after the implementation of the improvement program
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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