Acute AppendicitisWIRES-TNCT03643718
Web-based International Register of Emergency Surgery and Trauma
An observational study of Acute Appendicitis and Acute Cholecystitis, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Appendicitis, Acute Cholecystitis, Acute Diverticulitis
- What is being tested?
- Emergency General Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2020to Sep 2030
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients not affected by an acute surgical disease
- Patients without indication to be referred to the emergency surgeon attention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
General, Emergency and Trauma surgery, University Hospital of Pisa
Pisa
Federico Coccolini, MD, 050-996123, federico.coccolini@gmail.com
About this study
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.
- Conditions
- Acute Appendicitis, Acute Cholecystitis, Acute Diverticulitis, Post-operative Complications, Acute Pancreatitis, Perforated Gastro-duodenal Ulcers
- Being tested
- Emergency General Surgery
- Medical subject headings
- Appendicitis, Cholecystitis, Acute, Pancreatitis, Hernia, Abdominal, Foreign Bodies, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency General SurgeryProcedure or surgery
Also called Trauma
Emergency General Surgery and Trauma operative/non operative management
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until hospital discharge, approximately 2 weeks
Rate of patients treated with conservative treatment
Evaluate the conservative treatment rate for each different disease according to patient's characteristics and the enviroinment.
Measured: Until hospital discharge, approximately 2 weeks
Secondary outcomes (2)
Mortality
To evaluate the differences in mortality rate linked to the different managements, techniques, environments and patient variables.
Measured: Until hospital discharge, approximately 2 weeks
Morbidity
To evaluate the differences in morbidity rate linked to the different managements, techniques, environments and patient variables.
Measured: Until hospital discharge, approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study startJul 2020 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Collaborators
- World Society of Emergency Surgery, University of Pisa
- Responsible party
- Principal investigator, Federico Coccolini, MD, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643718
- Sponsor's protocol ID
- FC-001-2018
- Acronym
- WIRES-T
- Status last verified
- Jul 2020
- First submitted
- 14 May 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coccolini F, Mazzoni A, Cremonini C, Cobuccio L, Pucciarelli M, Vetere G, Borelli B, Strambi S, Musetti S, Miccoli M, Cremolini C; WIRES-T Study Group; Tartaglia D, Chiarugi M. Colorectal neoplastic emergencies in immunocompromised patients: preliminary result from the Web-based International Register of Emergency Surgery and Trauma (WIRES-T trial). Updates Surg. 2023 Sep;75(6):1579-1587. doi: 10.1007/s13304-023-01521-8. Epub 2023 May 9.
PubMed 37160552
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based International Register of Emergency Surgery and Trauma
- ClinicalTrials.gov ID
- NCT03643718
- Acronym / sponsor ID
- WIRES-T / FC-001-2018
- Conditions
- Acute Appendicitis, Acute Cholecystitis, Acute Diverticulitis, Post-operative Complications, Acute Pancreatitis, Perforated Gastro-duodenal Ulcers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Collaborators
- World Society of Emergency Surgery, University of Pisa
- Study start
- Jul 2020 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients not affected by an acute surgical disease
- Patients without indication to be referred to the emergency surgeon attention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency General SurgeryAlso: TraumaEmergency General Surgery and Trauma operative/non operative management | Procedure or surgery | – |
Primary outcome
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.
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.
2 secondary outcomes
Mortality
Time frame: Until hospital discharge, approximately 2 weeks
Morbidity
Time frame: Until hospital discharge, approximately 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 37160552Coccolini F, Mazzoni A, Cremonini C, Cobuccio L, Pucciarelli M, Vetere G, Borelli B, Strambi S, Musetti S, Miccoli M, Cremolini C; WIRES-T Study Group; Tartaglia D, Chiarugi M. Colorectal neoplastic emergencies in immunocompromised patients: preliminary result from the Web-based International Register of Emergency Surgery and Trauma (WIRES-T trial). Updates Surg. 2023 Sep;75(6):1579-1587. doi: 10.1007/s13304-023-01521-8. Epub 2023 May 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis and Acute Cholecystitis, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Coccolini, MD (0039-050996123, federico.coccolini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients treated with surgery (time frame: Until hospital discharge, approximately 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03643718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020; AzTrials last refreshed its copy on 26 Oct 2026.