AppendicitisNCT05205681
The Role of Imaging in the Diagnosis of Acute Appendicitis During the COVID-19 Pandemic
An observational study of Appendicitis, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
This is a retrospective observational study in the form of a cohort study evaluating the use of pre-operative imaging for the diagnosis of acute appendicitis in a tertiary centre during the first and second waves of the COVID-19 pandemic in the United Kingdom. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendicitis
- What is being tested?
- Pre-operative imaging
- How many people
- 313 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2021to 31 Jan 2022
- 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 consecutive patients operated at a tertiary centre
Who may be able to join
- Patients of all ages who underwent emergency appendicectomy (either laparoscopic or open) for suspected acute appendicitis
- Patients of all ages who underwent partial ileo-caecectomy or right hemicolectomy for suspected acute appendicitis
Who cannot join
- Patients who underwent elective interval appendicectomy for a previous appendiceal phlegmon
- Patients who underwent appendicectomy or right hemicolectomy for appendiceal tumours
- Patients who underwent diagnostic laparoscopy for suspected acute appendicitis, where the appendix was not removed
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
About this study
Official title: The Role of Imaging in the Diagnosis of Acute Appendicitis During the COVID-19 Pandemic: a Retrospective Cohort Study
This is a retrospective observational study in the form of a cohort study evaluating the use of pre-operative imaging for the diagnosis of acute appendicitis in a tertiary centre during the first and second waves of the COVID-19 pandemic in the United Kingdom. The study group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2020 and February 2021, while the control group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2019 and February 2020. The final histology will be used as primary outcome, as the study hypothesis is that increasing the use of pre-operative imaging will reduce the negative appendicectomy rate.
- Conditions
- Appendicitis
- Being tested
- Pre-operative imaging
- Keywords
- appendicitis, COVID-19, negative appendicectomy rate, computer tomography, ultrasonography, pre-operative imaging
- Medical subject headings
- Appendicitis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative imagingDiagnostic test
Use of pre-operative imaging or the diagnosis of acute appendicitis
| Study group | Role | What they receive |
|---|---|---|
| Pandemic Group | All patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2020 and February 2021 Receives: Diagnostic Test: Pre-operative imaging | |
| Control Group | All patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2019 and February 2020 Receives: Diagnostic Test: Pre-operative imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Appendicectomy Rate (NAR)
Number of patients with final histology negative for acute appendicitis
Measured: Up to 3 weeks post-operatively (when final Histology is ready)
Secondary outcomes (2)
Post-Operative Length of Stay
Post-operative length of hospital stay (from post-operative day 1)
Measured: Assessed on day 30 after the completion of the study
Post-Operative Complications Rate
Number of patients who had post-operative complications
Measured: Within 30 post-operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Dec 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 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
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Gerardo Perrotta, University College London Hospitals
- Investigators
- Gerardo Perrotta, MD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205681
- Sponsor's protocol ID
- NARCO2021
- Status last verified
- Feb 2022
- First submitted
- 7 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perrotta G, Geropoulos G, Bhan C. The role of imaging in the diagnosis of acute appendicitis during the COVID-19 pandemic: a retrospective cohort study. Updates Surg. 2023 Jan;75(1):205-208. doi: 10.1007/s13304-022-01426-y. Epub 2022 Nov 24.
PubMed 36422811
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Imaging in the Diagnosis of Acute Appendicitis During the COVID-19 Pandemic: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05205681
- Acronym / sponsor ID
- NARCO2021
- Conditions
- Appendicitis
- Keywords
- appendicitis, COVID-19, negative appendicectomy rate, computer tomography, ultrasonography, pre-operative imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 25 Jan 2022 (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.
This is a retrospective observational study in the form of a cohort study evaluating the use of pre-operative imaging for the diagnosis of acute appendicitis in a tertiary centre during the first and second waves of the COVID-19 pandemic in the United Kingdom. The study group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2020 and February 2021, while the control group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2019 and February 2020. The final histology will be used as primary outcome, as the study hypothesis is that increasing the use of pre-operative imaging will reduce the negative appendicectomy rate.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pandemic Group | – | Diagnostic Test: Pre-operative imagingAll patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2020 and February 2021 |
| Control Group | – | Diagnostic Test: Pre-operative imagingAll patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2019 and February 2020 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients operated at a tertiary centre
Key inclusion criteria (2 listed)
- Patients of all ages who underwent emergency appendicectomy (either laparoscopic or open) for suspected acute appendicitis
- Patients of all ages who underwent partial ileo-caecectomy or right hemicolectomy for suspected acute appendicitis
Key exclusion criteria (3 listed)
- Patients who underwent elective interval appendicectomy for a previous appendiceal phlegmon
- Patients who underwent appendicectomy or right hemicolectomy for appendiceal tumours
- Patients who underwent diagnostic laparoscopy for suspected acute appendicitis, where the appendix was not removed
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 |
|---|---|---|
| Pre-operative imagingUse of pre-operative imaging or the diagnosis of acute appendicitis | Diagnostic test | Control Group, Pandemic Group |
Primary outcome
Negative Appendicectomy Rate (NAR)
Time frame: Up to 3 weeks post-operatively (when final Histology is ready)
Number of patients with final histology negative for acute appendicitis
2 secondary outcomes
Post-Operative Length of Stay
Time frame: Assessed on day 30 after the completion of the study
Post-Operative Complications Rate
Time frame: Within 30 post-operative days
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 3 Feb 2022.
- Derived from this study: PubMed 36422811Perrotta G, Geropoulos G, Bhan C. The role of imaging in the diagnosis of acute appendicitis during the COVID-19 pandemic: a retrospective cohort study. Updates Surg. 2023 Jan;75(1):205-208. doi: 10.1007/s13304-022-01426-y. Epub 2022 Nov 24.
- 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.
Gerardo Perrotta, MD principal investigator
University College London Hospitals
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 Appendicitis, run by University College London Hospitals at 1 site in United Kingdom.
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 2 inclusion and 3 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 3 Feb 2022. 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 United Kingdom. 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?
Negative Appendicectomy Rate (NAR) (time frame: Up to 3 weeks post-operatively (when final Histology is ready)). 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 NCT05205681, 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 3 Feb 2022.