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RecruitingNCT03643718WIRES-TUpdated Jul 14, 2020

Web-based International Register of Emergency Surgery and Trauma

An observational study in Acute Appendicitis, Acute Cholecystitis and Acute Diverticulitis, sponsored by A.O. Ospedale Papa Giovanni XXIII. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by A.O. Ospedale Papa Giovanni XXIII · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Appendicitis
  • Acute Cholecystitis
  • Acute Diverticulitis
  • Post-operative Complications
  • Acute Pancreatitis
  • Perforated Gastro-duodenal Ulcers
  • Adhesive Small Bowell Occlusion
  • Colonic Neoplastic Emergencies
  • Gynecological Emergencies
  • Vascular Emergencies
  • Intestinal Ischemia
  • Abdominal Wall Hernia
  • Foreign Bodies
  • Caustic Ingestion
  • Trauma
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Patients not affected by an acute surgical disease
  • Patients without indication to be referred to the emergency surgeon attention
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
2 Weeks
Patient registry
Yes

Interventions

  • ProcedureEmergency General Surgery

    Emergency General Surgery and Trauma operative/non operative management

    Also known as: Trauma

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Until hospital discharge, approximately 2 weeks

  2. Rate of patients treated with conservative treatment

    Evaluate the conservative treatment rate for each different disease according to patient's characteristics and the enviroinment.

    Time frame: Until hospital discharge, approximately 2 weeks

Secondary outcomes

  1. Mortality

    To evaluate the differences in mortality rate linked to the different managements, techniques, environments and patient variables.

    Time frame: Until hospital discharge, approximately 2 weeks

  2. Morbidity

    To evaluate the differences in morbidity rate linked to the different managements, techniques, environments and patient variables.

    Time frame: Until hospital discharge, approximately 2 weeks

06

Study locations

1 of 1 sites recruiting
  • General, Emergency and Trauma surgery, University Hospital of Pisa
    Pisa, Italy
    Recruiting
07

Registry details

Key details

Study ID
NCT03643718
Lead sponsor
A.O. Ospedale Papa Giovanni XXIII
Collaborators
World Society of Emergency Surgery, University of Pisa
Responsible party
Federico Coccolini, MD (Attending Surgeon, University of Pisa) — Principal investigator
First posted
Aug 23, 2018
Start date
Jul 2020 (estimated)
Primary completion
Sep 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Jul 14, 2020

Study contacts

Federico Coccolini, MD
Contact
federico.coccolini@gmail.com
0039-050996123

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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