Web-based International Register of Emergency Surgery and Trauma (WIRES-T)

July 10, 2020 updated by: Federico Coccolini, MD, A.O. Ospedale Papa Giovanni XXIII
The WIRES-T project (Web-based International Registry of Emergency General Surgery and Trauma) has been set up to allow to all the EGS (Emergency General Surgery) and Trauma surgeons to register their activity and to obtain a worldwide register of traumatic and non traumatic surgical emergencies. This will give the opportunity to evaluate results on a macro-data basis and to give index allowing stratifying, evaluating and improving the outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Pisa, Italy
        • Recruiting
        • General, Emergency and Trauma surgery, University Hospital of Pisa
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients affected by an acute surgical disease and/or who may require to be undergone to the emergency surgeon attention to be managed either with an operative or a non-operative approach.

Description

Inclusion Criteria:

  • Patients affected by an acute surgical disease
  • Patients with indication to be referred to the emergency surgeon attention
  • Patients to be operated or to be treated with non-operative approach without surgical intervention

Exclusion Criteria:

  • Patients not affected by an acute surgical disease
  • Patients without indication to be referred to the emergency surgeon attention

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients treated with surgery
Time Frame: Until hospital discharge, approximately 2 weeks
Evaluate the rate of operative treatment for each different disease according to the different enviroment; for each intervention the surgical approach (laparotomic, mini-invasive, laparoscopic) will be evaluated.
Until hospital discharge, approximately 2 weeks
Rate of patients treated with conservative treatment
Time Frame: Until hospital discharge, approximately 2 weeks
Evaluate the conservative treatment rate for each different disease according to patient's characteristics and the enviroinment.
Until hospital discharge, approximately 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Until hospital discharge, approximately 2 weeks
To evaluate the differences in mortality rate linked to the different managements, techniques, environments and patient variables.
Until hospital discharge, approximately 2 weeks
Morbidity
Time Frame: Until hospital discharge, approximately 2 weeks
To evaluate the differences in morbidity rate linked to the different managements, techniques, environments and patient variables.
Until hospital discharge, approximately 2 weeks

Collaborators and Investigators

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

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Collaborators

University of Pisa
World Society of Emergency Surgery

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 (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

September 1, 2030

Study Completion (Anticipated)

September 1, 2030

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FC-001-2018

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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