Covid19NCT04786041
the Impact of COVID-19 Pandemic on the Incidence and Outcome of Complicated Appendicitis
An observational study of Covid19 and Appendicitis, run by Meir Medical Center at 1 site in Israel.
Trial summary
During the COVID-19 pandemic, we noticed a rise in complicated appendicitis cases presenting to our medical center. We collected objective data on all patients admitted to the surgical department with appendicitis during February 2020 - March 2020 compared to the same 2 month period in 2019, to understand the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Appendicitis
- What is being tested?
- laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2020to 30 May 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 who underwent appendectomy in meir medical center, during the study period
Who may be able to join
- appendicitis
Who cannot join
- any other diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lockdown With a Price- the Impact of COVID-19 Pandemic on the Incidence and Outcome of Complicated Appendicitis
During the COVID-19 pandemic, we noticed a rise in complicated appendicitis cases presenting to our medical center. We collected objective data on all patients admitted to the surgical department with appendicitis during February 2020 - March 2020 compared to the same 2 month period in 2019, to understand the pandemic's affect on the rate of complications of acute appendicitis.
Read the detailed description
Coronavirus pandemic (COVID-19) first broke out in Wuhan and Hubei China during december 2019. On 30 January, WHO declared it a Public Health Emergency of International Concern (PHEIC) .
Currently, the number of cases worldwide stands stands at more than 76 million confirmed cases according to the World Health Organization (WHO) records. First documented case in Israel was reported on 21st of february 2020.
During the months of February and April, due to continued rise in confirmed cases, rigid "stay at home" restrictions were issued. These restrictions have had a significant effect on daily life. Under these new "stay at home" policies, many aspects of everyday life were greatly diminished and restricted under threat of heavy fines. This effect also extends to reduction in healthcare seeking. decline in emergency department (ED) visits was reported. A drop in routine cancer screening appointments was reported.
Delayed healthcare seeking also had an affect on the severity of various medical conditions on presentation. fear of the COVID-19 pandemic may have resulted in delayed diagnosis, and therefore higher complication rates in common medical conditions.
acute appendicitis (AA) is among the most common causes of lower abdominal pain leading patients to attend the emergency department. As such, AA could serve as a good indicator for the possible effect that the fear of the COVID-19 pandemic had on patients tendency for late diagnosis and complication rate.
Gomes Laparoscopic Grading System of AA, classifies appendicitis into five laparoscopic grades according to gross morphologic findings during surgical laparoscopy. grades 1 and 2 regarded as non-complicated appendicitis, while grades 3, 4 and 5 regarded as complicated appendicitis.
Following the restrictions imposed during the COVID-19 pandemic, we noticed a rise in complicated appendicitis cases presenting to our medical center. We collected objective data on all patients admitted to the surgical department with appendicitis during February 2020 - March 2020 compared to the same 2 month period in 2019. Data such as the time period from onset of symptoms to presenting to the ED, inflammatory markers, complicated appendicitis (if any), type of complication, post operative complications. We aim to assess whether the "stay at home" restrictions had any adverse effects on severity or outcomes of AA.
- Conditions
- Covid19, Appendicitis
- Being tested
- laparoscopic appendectomy
- Keywords
- COVID19, appendicitis, laparoscopy
- Medical subject headings
- COVID-19, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic appendectomyProcedure or surgery
Also called abscess drainage, consevative treatment
laparoscopic appendectomy
| Study group | Role | What they receive |
|---|---|---|
| underwent Appendectomy during march-april of 2019 | all patients who underwent Appendectomy during the period of march-april of 2019 Receives: Procedure: laparoscopic appendectomy | |
| underwent Appendectomy during march-april of 2020 (during covid pandemic) | all patients who underwent Appendectomy during the period of march-april of 2020 (during the COVID19 pandemic lockdown) Receives: Procedure: laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complicated appendicitis
any complication during surgery or post-operatively
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Mar 2020
- Primary completion30 May 2020
- Study completion30 May 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 Covid19Studies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yaron rudnicki, Meir Medical Center
- Investigators
- Yaron Rudnicki, MD, Study director, Meir medical center, surgical ward B.Yaron Rudnicki, MD, Principal investigator, Meir medical center, surgical ward B.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786041
- Sponsor's protocol ID
- MMC-0223-20
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rudnicki Y, Soback H, Mekiten O, Lifshiz G, Avital S. The impact of COVID-19 pandemic lockdown on the incidence and outcome of complicated appendicitis. Surg Endosc. 2022 May;36(5):3460-3466. doi: 10.1007/s00464-021-08667-9. Epub 2021 Jul 26.
PubMed 34312724
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lockdown With a Price- the Impact of COVID-19 Pandemic on the Incidence and Outcome of Complicated Appendicitis
- ClinicalTrials.gov ID
- NCT04786041
- Acronym / sponsor ID
- MMC-0223-20
- Conditions
- Covid19, Appendicitis
- Keywords
- COVID19, appendicitis, laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 8 Mar 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.
During the COVID-19 pandemic, we noticed a rise in complicated appendicitis cases presenting to our medical center. We collected objective data on all patients admitted to the surgical department with appendicitis during February 2020 - March 2020 compared to the same 2 month period in 2019, to understand the pandemic's affect on the rate of complications of acute appendicitis.
Detailed description
Coronavirus pandemic (COVID-19) first broke out in Wuhan and Hubei China during december 2019. On 30 January, WHO declared it a Public Health Emergency of International Concern (PHEIC) .
Currently, the number of cases worldwide stands stands at more than 76 million confirmed cases according to the World Health Organization (WHO) records. First documented case in Israel was reported on 21st of february 2020.
During the months of February and April, due to continued rise in confirmed cases, rigid "stay at home" restrictions were issued. These restrictions have had a significant effect on daily life. Under these new "stay at home" policies, many aspects of everyday life were greatly diminished and restricted under threat of heavy fines. This effect also extends to reduction in healthcare seeking. decline in emergency department (ED) visits was reported. A drop in routine cancer screening appointments was reported.
Delayed healthcare seeking also had an affect on the severity of various medical conditions on presentation. fear of the COVID-19 pandemic may have resulted in delayed diagnosis, and therefore higher complication rates in common medical conditions.
acute appendicitis (AA) is among the most common causes of lower abdominal pain leading patients to attend the emergency department. As such, AA could serve as a good indicator for the possible effect that the fear of the COVID-19 pandemic had on patients tendency for late diagnosis and complication rate.
Gomes Laparoscopic Grading System of AA, classifies appendicitis into five laparoscopic grades according to gross morphologic findings during surgical laparoscopy. grades 1 and 2 regarded as non-complicated appendicitis, while grades 3, 4 and 5 regarded as complicated appendicitis.
Following the restrictions imposed during the COVID-19 pandemic, we noticed a rise in complicated appendicitis cases presenting to our medical center. We collected objective data on all patients admitted to the surgical department with appendicitis during February 2020 - March 2020 compared to the same 2 month period in 2019. Data such as the time period from onset of symptoms to presenting to the ED, inflammatory markers, complicated appendicitis (if any), type of complication, post operative complications. We aim to assess whether the "stay at home" restrictions had any adverse effects on severity or outcomes of AA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| underwent Appendectomy during march-april of 2019 | – | Procedure: laparoscopic appendectomyall patients who underwent Appendectomy during the period of march-april of 2019 |
| underwent Appendectomy during march-april of 2020 (during covid pandemic) | – | Procedure: laparoscopic appendectomyall patients who underwent Appendectomy during the period of march-april of 2020 (during the COVID19 pandemic lockdown) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients who underwent appendectomy in meir medical center, during the study period
Key inclusion criteria (1 listed)
- appendicitis
Key exclusion criteria (1 listed)
- any 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 |
|---|---|---|
| laparoscopic appendectomyAlso: abscess drainage, consevative treatmentlaparoscopic appendectomy | Procedure or surgery | underwent Appendectomy during march-april of 2019, underwent Appendectomy during march-april of 2020 (during covid pandemic) |
Primary outcome
complicated appendicitis
Time frame: 30 days
any complication during surgery or post-operatively
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 8 Mar 2021.
- Derived from this study: PubMed 34312724Rudnicki Y, Soback H, Mekiten O, Lifshiz G, Avital S. The impact of COVID-19 pandemic lockdown on the incidence and outcome of complicated appendicitis. Surg Endosc. 2022 May;36(5):3460-3466. doi: 10.1007/s00464-021-08667-9. Epub 2021 Jul 26.
- 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.
Yaron Rudnicki, MD study director
Meir medical center, surgical ward B.
Yaron Rudnicki, MD principal investigator
Meir medical center, surgical ward B.
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 Covid19 and Appendicitis, run by Meir Medical Center at 1 site in Israel.
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 8 Mar 2021. 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 Israel. 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: 30 days). 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 NCT04786041, 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 8 Mar 2021.