Covid19NCT05012839
Complicated Appendicitis in COVID-19 Era
An observational study of Covid19 and Complicated Appendicitis, run by National Taiwan University Hospital.
Trial summary
Background The impact of the coronavirus disease 2019 (COVID-19) pandemic on medical services is overwhelming due to limited medical resources. During its initial surge in 2020, Taiwan's government rapidly established diverse public actions, which helped maintain the medical supply without travel restrictions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Covid19, Complicated Appendicitis
- What is being tested?
- impact of COVID-19 on Health-Seeking Behaviors
- How many people
- 465 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 14 Aug 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective analysis of acute appendicitis in adults was performed between January 1 and June 30, 2020 (COVID-19 period). The control period was collected from the first two quarters for the preceding 3 years. Outcome measures were ACA and length of hospital stays.
Who may be able to join
- Acute appendicitis
Who cannot join
- No
About this study
Official title: Increased Incidence of Adult Complicated Appendicitis in One Resource-Competent Community During the Coronavirus Disease Pandemic: Time to Improve Health-Seeking Behaviors
Background The impact of the coronavirus disease 2019 (COVID-19) pandemic on medical services is overwhelming due to limited medical resources. During its initial surge in 2020, Taiwan's government rapidly established diverse public actions, which helped maintain the medical supply without travel restrictions. However, whether the fear of being infected with COVID-19 interfered with health-seeking behavior (HSB) remains unclear. Therefore, this study aimed to elucidate whether acute complicated appendicitis (ACA) rates in adults were affected by the COVID-19 pandemic.
Methods A retrospective analysis of acute appendicitis in adults was performed between January 1 and June 30, 2020 (COVID-19 period). The control period was collected from the first two quarters for the preceding 3 years. Outcome measures were ACA and length of hospital stays.
- Conditions
- Covid19, Complicated Appendicitis
- Being tested
- impact of COVID-19 on Health-Seeking Behaviors
- Keywords
- Health-seeking behavior, COVID-19, appendicitis
- Medical subject headings
- COVID-19, Health Behavior, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impact of COVID-19 on Health-Seeking BehaviorsOther
The impact of the coronavirus disease 2019 (COVID-19) pandemic on medical services is overwhelming due to limited medical resources. During its initial surge in 2020, Taiwan's government rapidly established diverse public actions, which helped maintain the medical supply without travel restrictions. However, whether the fear of being infected with COVID-19 interfered with health-seeking behavior (HSB) remains unclear. Therefore, this study aimed to elucidate whether acute complicated appendicitis (ACA) rates in adults were affected by the COVID-19 pandemic.
| Study group | Role | What they receive |
|---|---|---|
| Complicated appendicitis | The development of complicated appendicitis, diagnosed during appendectomy or by pre-operative image study Receives: Other: impact of COVID-19 on Health-Seeking Behaviors | |
| Non-complicated appendicitis | No development of complicated appendicitis, diagnosed during appendectomy or by pre-operative image study Receives: Other: impact of COVID-19 on Health-Seeking Behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complicated appendicitis
The primary outcome measure was the occurrence of ACA defined as abscess observed in computed tomography, presence of appendiceal perforation determined by surgical documentation, or a description of gangrenous appendicitis assessed by pathological reports.
Measured: baseline, pre-surgery
Secondary outcomes (1)
Length of hospital stays
the duration of hospital stays after surgery
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Jan 2017
- Primary completion30 Jun 2020
- Study completion14 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012839
- Sponsor's protocol ID
- 202008052RINC
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Incidence of Adult Complicated Appendicitis in One Resource-Competent Community During the Coronavirus Disease Pandemic: Time to Improve Health-Seeking Behaviors
- ClinicalTrials.gov ID
- NCT05012839
- Acronym / sponsor ID
- 202008052RINC
- Conditions
- Covid19, Complicated Appendicitis
- Keywords
- Health-seeking behavior, COVID-19, appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 14 Aug 2021 (actual)
- First posted
- 19 Aug 2021 (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.
Background The impact of the coronavirus disease 2019 (COVID-19) pandemic on medical services is overwhelming due to limited medical resources. During its initial surge in 2020, Taiwan's government rapidly established diverse public actions, which helped maintain the medical supply without travel restrictions. However, whether the fear of being infected with COVID-19 interfered with health-seeking behavior (HSB) remains unclear. Therefore, this study aimed to elucidate whether acute complicated appendicitis (ACA) rates in adults were affected by the COVID-19 pandemic.
Methods A retrospective analysis of acute appendicitis in adults was performed between January 1 and June 30, 2020 (COVID-19 period). The control period was collected from the first two quarters for the preceding 3 years. Outcome measures were ACA and length of hospital stays.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complicated appendicitis | – | Other: impact of COVID-19 on Health-Seeking BehaviorsThe development of complicated appendicitis, diagnosed during appendectomy or by pre-operative image study |
| Non-complicated appendicitis | – | Other: impact of COVID-19 on Health-Seeking BehaviorsNo development of complicated appendicitis, diagnosed during appendectomy or by pre-operative image study |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective analysis of acute appendicitis in adults was performed between January 1 and June 30, 2020 (COVID-19 period). The control period was collected from the first two quarters for the preceding 3 years. Outcome measures were ACA and length of hospital stays.
Key inclusion criteria (1 listed)
- Acute appendicitis
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| impact of COVID-19 on Health-Seeking BehaviorsThe impact of the coronavirus disease 2019 (COVID-19) pandemic on medical services is overwhelming due to limited medical resources. During its initial surge in 2020, Taiwan's government rapidly established diverse public actions, which helped maintain the medical supply without travel restrictions. However, whether the fear of being infected with COVID-19 interfered with health-seeking behavior (HSB) remains unclear. Therefore, this study aimed to elucidate whether acute complicated appendicitis (ACA) rates in adults were affected by the COVID-19 pandemic. | Other | Complicated appendicitis, Non-complicated appendicitis |
Primary outcome
Incidence of complicated appendicitis
Time frame: baseline, pre-surgery
The primary outcome measure was the occurrence of ACA defined as abscess observed in computed tomography, presence of appendiceal perforation determined by surgical documentation, or a description of gangrenous appendicitis assessed by pathological reports.
1 secondary outcome
Length of hospital stays
Time frame: up to 4 weeks
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 19 Aug 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Complicated Appendicitis, run by National Taiwan University Hospital.
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 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of complicated appendicitis (time frame: baseline, pre-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2021.