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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

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 200 across 151 observational studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

A.O. Ospedale Papa Giovanni XXIII is the lead sponsor of 32 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 of 1 sites recruiting
  • General, Emergency and Trauma surgery, University Hospital of Pisa
    Pisa, Italy
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2020; primary completion for Sep 2030, 122 months later.

Of 54 non-industry observational studies under Appendicitis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 56. This study's planned 122 months is above that.

Counting every sponsor, half of 56 studies reached it within 23 months; a quarter within 7 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2018
First posted
Aug 23, 2018
StartEst.
Jul 2020
Primary completionEst.
Sep 2030
CompletionEst.
Sep 2030
Last update
Jul 14, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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