Acute AppendicitisNCT04649996
Variation in Acute Appendicitis During COVID-19 Pandemic in Italy
An observational study of Acute Appendicitis, run by University of Milano Bicocca at 6 sites in Italy.
Trial summary
retrospective observational study of variation in incidence and clinical presentation of appendicitis during the pandemic in northern Italy, compared with the same period in the previous 2 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 532 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Sep 2020to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 admitted in hospital for acute appendicitis
Who may be able to join
- acute appendicitis
Who cannot join
- other diagnosis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Ospedale Manzoni
Lecco, LC
ASST Lodi
Lodi
Ospedale San Raffaele
Milan, Mi
ASST Monza
Monza, MB, 20900
Azienda ospedaliero-universitaria Pisana,Ospedale Cisanello
Pisa
Policlinico San Pietro
Ponte San Pietro, BG
About this study
Official title: Variation of Incidence and Clinical Presentation of Acute Appendicitis During a Pandemic.
retrospective observational study of variation in incidence and clinical presentation of appendicitis during the pandemic in northern Italy, compared with the same period in the previous 2 years.
- Conditions
- Acute Appendicitis
- Being tested
- Appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
Also called Conservative treatment
comparison between operative and conservative treatment
| Study group | Role | What they receive |
|---|---|---|
| Pandemic period | patients admitted in hospital for acute appendicitis Receives: Procedure: Appendectomy | |
| control period | patients admitted in hospital for acute appendicitis Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complicated appendicitis
Number of patients with complicated acute appendicitis
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Sep 2020
- Primary completion31 Oct 2020
- Study completion30 Nov 2020
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
- Retrospective
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649996
- Sponsor's protocol ID
- Appendicitis-pandemic
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ceresoli M, Coccolini F, Magnone S, Lucianetti A, Bisagni P, Armao T, Ansaloni L, Zago M, Chiarugi M, Catena F, Braga M; Appendicitis-COVID study group. The decrease of non-complicated acute appendicitis and the negative appendectomy rate during pandemic. Eur J Trauma Emerg Surg. 2021 Oct;47(5):1359-1365. doi: 10.1007/s00068-021-01663-7. Epub 2021 Apr 12.
PubMed 33844036
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation of Incidence and Clinical Presentation of Acute Appendicitis During a Pandemic.
- ClinicalTrials.gov ID
- NCT04649996
- Acronym / sponsor ID
- Appendicitis-pandemic
- Conditions
- Acute Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 2 Dec 2020 (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.
retrospective observational study of variation in incidence and clinical presentation of appendicitis during the pandemic in northern Italy, compared with the same period in the previous 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pandemic period | – | Procedure: Appendectomypatients admitted in hospital for acute appendicitis |
| control period | – | Procedure: Appendectomypatients admitted in hospital for acute appendicitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted in hospital for acute appendicitis
Key inclusion criteria (1 listed)
- acute appendicitis
Key exclusion criteria (1 listed)
- other diagnosis
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 |
|---|---|---|
| AppendectomyAlso: Conservative treatmentcomparison between operative and conservative treatment | Procedure or surgery | Pandemic period, control period |
Primary outcome
complicated appendicitis
Time frame: 2 months
Number of patients with complicated acute appendicitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Derived from this study: PubMed 33844036Ceresoli M, Coccolini F, Magnone S, Lucianetti A, Bisagni P, Armao T, Ansaloni L, Zago M, Chiarugi M, Catena F, Braga M; Appendicitis-COVID study group. The decrease of non-complicated acute appendicitis and the negative appendectomy rate during pandemic. Eur J Trauma Emerg Surg. 2021 Oct;47(5):1359-1365. doi: 10.1007/s00068-021-01663-7. Epub 2021 Apr 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites 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, run by University of Milano Bicocca at 6 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complicated appendicitis (time frame: 2 months). 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 NCT04649996, 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 4 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.