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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03643718
Other study ID # FC-001-2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2020
Est. completion date September 2030

Study information

Verified date July 2020
Source A.O. Ospedale Papa Giovanni XXIII
Contact Federico Coccolini, MD
Phone 0039-050996123
Email federico.coccolini@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date September 2030
Est. primary completion date September 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Abdominal Wall Hernia
  • Acute Appendicitis
  • Acute Cholecystitis
  • Acute Diverticulitis
  • Acute Pancreatitis
  • Adhesive Small Bowell Occlusion
  • Appendicitis
  • Caustic Ingestion
  • Cholecystitis
  • Cholecystitis, Acute
  • Colonic Neoplastic Emergencies
  • Diverticulitis
  • Duodenal Ulcer
  • Emergencies
  • Foreign Bodies
  • Gynecological Emergencies
  • Hernia, Ventral
  • Intestinal Ischemia
  • Pancreatitis
  • Peptic Ulcer
  • Perforated Gastro-duodenal Ulcers
  • Post-operative Complications
  • Postoperative Complications
  • Trauma
  • Vascular Emergencies
  • Wounds and Injuries

Intervention

Procedure:
Emergency General Surgery
Emergency General Surgery and Trauma operative/non operative management

Locations

Country Name City State
Italy General, Emergency and Trauma surgery, University Hospital of Pisa Pisa

Sponsors (3)

Lead Sponsor Collaborator
A.O. Ospedale Papa Giovanni XXIII University of Pisa, World Society of Emergency Surgery

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of patients treated with surgery 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
Primary Rate of patients treated with conservative treatment Evaluate the conservative treatment rate for each different disease according to patient's characteristics and the enviroinment. Until hospital discharge, approximately 2 weeks
Secondary Mortality To evaluate the differences in mortality rate linked to the different managements, techniques, environments and patient variables. Until hospital discharge, approximately 2 weeks
Secondary Morbidity To evaluate the differences in morbidity rate linked to the different managements, techniques, environments and patient variables. Until hospital discharge, approximately 2 weeks
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