Presentation and Outcomes of Acute Appendicitis During COVID Pandemic (AA)

November 1, 2021 updated by: Ayman El Nakeeb, Mansoura University

Presentation and Outcomes of Acute Appendicitis During COVID Pandemic: Lessons Learned From the Middle East (Multicenter Study)

Acute appendicitis (AA) is a frequent cause of acute abdominal pain in emergency rooms around the world [1]. The lifetime risk of developing AA is estimated to be about 8% [1-3]. The severe acute respiratory syndrome SARS-CoV-2 Coronavirus (COVID-19) pandemic has raised difficult situations for healthcare systems and organizations around the world, with direct and indirect implications for patient care delivery. COVID-19 causes a wide range of clinical symptoms, including fever, dry cough, myalgia, and exhaustion, with pulmonary involvement in many cases. According to the World Health Organization (WHO), The effect of the COVID-19 pandemic on acute appendicitis and surgical care is unknown due to a lack of evidence. To see how appendicitis care has changed as a result of the COVID-19 pandemic, this study compares clinical presentation, investigative modalities, treatment procedures, and outcomes before and after the pandemic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute appendicitis (AA) is a frequent cause of acute abdominal pain in emergency rooms around the world [1]. The lifetime risk of developing AA is estimated to be about 8% [1-3]. The SARS-CoV-2 Coronavirus (COVID-19) pandemic has raised difficult situations for healthcare systems and organizations around the world, with direct and indirect implications for patient care delivery. COVID-19 causes a wide range of clinical symptoms, including fever, dry cough, myalgia, and exhaustion, with pulmonary involvement in many cases. According to the World Health Organization (WHO), The effect of the COVID-19 pandemic on acute appendicitis and surgical care is unknown due to a lack of evidence. To see how appendicitis care has changed as a result of the COVID-19 pandemic, this study compares clinical presentation, investigative modalities, treatment procedures, and outcomes before and after the pandemic. This is a multicenter prospective cohort study that was conducted for patients presented with Acute Appendicitis (AA).

Study Type

Interventional

Enrollment (Actual)

1945

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 335111
        • Ayman El Nakeeb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

patients with acute appendicitis

Exclusion Criteria:

  • patients with acute appendicitis less than 12 years
  • malignant appendix

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Patients in group I (G1) had AA prior to the era of COVID
Procedure: appendectomy
open or laparoscopic appendectomy
Active Comparator: patients in group II (G2) had AA during COVID
Procedure: appendectomy
open or laparoscopic appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the management strategy used
Time Frame: one month
the management strategy used, which included conservative or surgical management (open or laparoscopic).
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical presentation
Time Frame: one month
Alverado score from 1 to 10 the worst score is 10
one month
postoperative complications
Time Frame: one month
postoperative complications have been classified by Dindo G1 TO G5
one month
the negative appendicectomy rate.
Time Frame: one month
This is normal appendix after appendectomy
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Ayman El E El Nakeeb, Mansoura University, Gastrointestinal Surgery Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2019

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

October 31, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • acute appendicitis (AA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the study protocol will be available for other researcher

IPD Sharing Time Frame

available for any researcher at any time

IPD Sharing Access Criteria

elnakeebayman@yahoo.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Study Data/Documents

  1. Study Protocol
    Information identifier: COVID and acute appendicitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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