COVID-19NCT05375058
Complicated Appendicitis During the COVID-19 Pandemic in Jordan
An observational study of COVID-19 and Complicated Appendicitis, run by Jordan University Hospital at 1 site in Jordan.
Trial summary
Comparing the incidence of complicated appendicitis between two groups, the pandemic and pre-pandemic groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Complicated Appendicitis
- What is being tested?
- Observational Study
- How many people
- 257 participants
- Where
- 1 siteJordan
- Study dates
- 2 Mar 2019to 28 Dec 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: Any patient that has a medical record for appendicitis and underwent appendectomy at University of Jordan hospital
Who may be able to join
- Any patient that presented with appendicitis and underwent an appendectomy at the university of Jordan hospital during the specified time periods (March 2019-December 2020)
Who cannot join
- Incomplete data record.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the COVID-19 Pandemic on the Incidence of Complicated Appendicitis in a Tertiary Medical Center, Amman, Jordan: A Retrospective Cohort
Comparing the incidence of complicated appendicitis between two groups, the pandemic and pre-pandemic groups.
Read the detailed description
The investigators have retrospectively investigated data on acute appendicitis cases. Two groups were established, the first group was the pandemic group, which included patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of March to the 6th of June 2020, and the pre-pandemic group which represents the same period in the previous year, the aim was to assess the incidence of complicated appendicitis during the COVID-19 pandemic in Jordan University Hospital
- Conditions
- COVID-19, Complicated Appendicitis
- Being tested
- Observational Study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
Observational Study; the study did not involve any interventions
| Study group | Role | What they receive |
|---|---|---|
| pandemic group (2020) | includes patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of March to the 6th of June 2020 Receives: Other: Observational Study | |
| pre-pandemic group (2019) | which represents the same period in the previous year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of postoperative complications
To determine if there were any complications, this was detected by reviewing the histopathology report
Measured: Up to 2 years
Secondary outcomes (3)
Length of in-hospital stay
How many days did the patient spend in the hospital until discharged.
Measured: Up to 2 years
Imaging method used for diagnosis (CT or US)
How was appendicitis diagnosed, either by using Computed Tomography (CT) Scan or Ultrasound.
Measured: Up to 2 years
Type of operation (open or laparoscopic)
We reported what type of operation the patient underwent to treat appendicitis.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start2 Mar 2019
- Primary completion28 Dec 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Raed Al-Qawasmeh, Jordan University Hospital
- Investigators
- Marzouq Amarin, MD, MSc, Principal investigator, Department of General Surgery, the University of Jordan, Amman, 11942, Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375058
- Sponsor's protocol ID
- 28/2021
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the COVID-19 Pandemic on the Incidence of Complicated Appendicitis in a Tertiary Medical Center, Amman, Jordan: A Retrospective Cohort
- ClinicalTrials.gov ID
- NCT05375058
- Acronym / sponsor ID
- 28/2021
- Conditions
- COVID-19, Complicated Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Jordan University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 16 May 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.
Comparing the incidence of complicated appendicitis between two groups, the pandemic and pre-pandemic groups.
Detailed description
The investigators have retrospectively investigated data on acute appendicitis cases. Two groups were established, the first group was the pandemic group, which included patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of March to the 6th of June 2020, and the pre-pandemic group which represents the same period in the previous year, the aim was to assess the incidence of complicated appendicitis during the COVID-19 pandemic in Jordan University Hospital
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pandemic group (2020) | – | Other: Observational Studyincludes patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of March to the 6th of June 2020 |
| pre-pandemic group (2019) | – | –which represents the same period in the previous year |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient that has a medical record for appendicitis and underwent appendectomy at University of Jordan hospital
Key inclusion criteria (1 listed)
- Any patient that presented with appendicitis and underwent an appendectomy at the university of Jordan hospital during the specified time periods (March 2019-December 2020)
Key exclusion criteria (1 listed)
- Incomplete data record.
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 |
|---|---|---|
| Observational StudyObservational Study; the study did not involve any interventions | Other | pandemic group (2020) |
Primary outcome
Occurrence of postoperative complications
Time frame: Up to 2 years
To determine if there were any complications, this was detected by reviewing the histopathology report
3 secondary outcomes
Length of in-hospital stay
Time frame: Up to 2 years
Imaging method used for diagnosis (CT or US)
Time frame: Up to 2 years
Type of operation (open or laparoscopic)
Time frame: Up to 2 years
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 16 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Marzouq Amarin, MD, MSc principal investigator
Department of General Surgery, the University of Jordan, Amman, 11942, Jordan
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 COVID-19 and Complicated Appendicitis, run by Jordan University Hospital at 1 site in Jordan.
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 16 May 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 Jordan. 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?
Occurrence of postoperative complications (time frame: Up to 2 years). 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 16 May 2022.