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the Impact of COVID-19 Pandemic on the Incidence and Outcome of Complicated Appendicitis

Sponsor
Meir Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04786041
Collaborator
(none)
200
Enrollment
1
Location
3
Actual Duration (Months)
67.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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 pandemic's affect on the rate of complications of acute appendicitis.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic appendectomy

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

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Lockdown With a Price- the Impact of COVID-19 Pandemic on the Incidence and Outcome of Complicated Appendicitis
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
May 30, 2020
Actual Study Completion Date :
May 30, 2020

Arms and Interventions

Arm Intervention/Treatment
underwent Appendectomy during march-april of 2019

all patients who underwent Appendectomy during the period of march-april of 2019

Procedure: laparoscopic appendectomy
laparoscopic appendectomy
Other Names:
  • abscess drainage
  • consevative treatment

    		•
    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)

    Procedure: laparoscopic appendectomy
    laparoscopic appendectomy
    Other Names:
  • abscess drainage
  • consevative treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. complicated appendicitis [30 days]

      any complication during surgery or post-operatively

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • appendicitis
    Exclusion Criteria:
    • any other diagnosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Meir medical center Kfar Saba Israel 4428139

    Sponsors and Collaborators

    • Meir Medical Center

    Investigators

    • Study Director: Yaron Rudnicki, MD, Meir medical center, surgical ward B.
    • Principal Investigator: Yaron Rudnicki, MD, Meir medical center, surgical ward B.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    yaron rudnicki, attending surgeon - surgical ward B, Meir medical center, Meir Medical Center
    ClinicalTrials.gov Identifier:
    NCT04786041
    Other Study ID Numbers:
    • MMC-0223-20
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Mar 8, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by yaron rudnicki, attending surgeon - surgical ward B, Meir medical center, Meir Medical Center
    COVID19
    appendicitis
    laparoscopy
    Additional relevant MeSH terms:
    COVID-19
    Appendicitis

    Study Results

    No Results Posted as of Mar 8, 2021