Presentation and Outcomes of Acute Appendicitis During COVID Pandemic (AA)
Primary Purpose
Acute Appendicitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Appendicitis
Eligibility Criteria
Inclusion Criteria:
patients with acute appendicitis
Exclusion Criteria:
- patients with acute appendicitis less than 12 years
- malignant appendix
Sites / Locations
- Ayman El Nakeeb
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Patients in group I (G1) had AA prior to the era of COVID
patients in group II (G2) had AA during COVID
Arm Description
Patients in group I (G1) had AA prior to the era of COVID
patients in group II (G2) had AA during COVID
Outcomes
Primary Outcome Measures
the management strategy used
the management strategy used, which included conservative or surgical management (open or laparoscopic).
Secondary Outcome Measures
clinical presentation
Alverado score from 1 to 10 the worst score is 10
postoperative complications
postoperative complications have been classified by Dindo G1 TO G5
the negative appendicectomy rate.
This is normal appendix after appendectomy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05104346
Brief Title
Presentation and Outcomes of Acute Appendicitis During COVID Pandemic
Acronym
AA
Official Title
Presentation and Outcomes of Acute Appendicitis During COVID Pandemic: Lessons Learned From the Middle East (Multicenter Study)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups of patients were created. Patients in group I (G1) had AA prior to the era of COVID, while patients in group II (G2) had AA during COVID
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
1945 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients in group I (G1) had AA prior to the era of COVID
Arm Type
Placebo Comparator
Arm Description
Patients in group I (G1) had AA prior to the era of COVID
Arm Title
patients in group II (G2) had AA during COVID
Arm Type
Active Comparator
Arm Description
patients in group II (G2) had AA during COVID
Intervention Type
Procedure
Intervention Name(s)
appendectomy
Intervention Description
open or laparoscopic appendectomy
Primary Outcome Measure Information:
Title
the management strategy used
Description
the management strategy used, which included conservative or surgical management (open or laparoscopic).
Time Frame
one month
Secondary Outcome Measure Information:
Title
clinical presentation
Description
Alverado score from 1 to 10 the worst score is 10
Time Frame
one month
Title
postoperative complications
Description
postoperative complications have been classified by Dindo G1 TO G5
Time Frame
one month
Title
the negative appendicectomy rate.
Description
This is normal appendix after appendectomy
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with acute appendicitis
Exclusion Criteria:
patients with acute appendicitis less than 12 years
malignant appendix
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman El E El Nakeeb
Organizational Affiliation
Mansoura University, Gastrointestinal Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman El Nakeeb
City
Mansoura
ZIP/Postal Code
335111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.mans.edu.eg/
Citations:
PubMed Identifier
34692596
Citation
Kim CW, Lee SH. Impact of COVID-19 on the care of acute appendicitis: a single-center experience in Korea. Ann Surg Treat Res. 2021 Oct;101(4):240-246. doi: 10.4174/astr.2021.101.4.240. Epub 2021 Oct 1.
Results Reference
result
PubMed Identifier
34700020
Citation
Kohler F, Muller S, Hendricks A, Kastner C, Reese L, Boerner K, Flemming S, Lock JF, Germer CT, Wiegering A. Changes in appendicitis treatment during the COVID-19 pandemic - A systematic review and meta-analysis. Int J Surg. 2021 Nov;95:106148. doi: 10.1016/j.ijsu.2021.106148. Epub 2021 Oct 23.
Results Reference
result
PubMed Identifier
34647160
Citation
Zheng Z, Bi JT, Liu YQ, Cai X. The impact of COVID-19 pandemic on the treatment of acute appendicitis in China. Int J Colorectal Dis. 2022 Jan;37(1):215-219. doi: 10.1007/s00384-021-04031-4. Epub 2021 Oct 13.
Results Reference
result
PubMed Identifier
34568625
Citation
Al Hashmi FY, Al Zuabi A, Hachim IY, Mannaerts GHH, Bekdache O. Conservative management of acute appendicitis in the era of COVID 19: A multicenter prospective observational study at the United Arab Emirates. Int J Surg Open. 2021 Oct;36:100389. doi: 10.1016/j.ijso.2021.100389. Epub 2021 Aug 25.
Results Reference
result
PubMed Identifier
34512909
Citation
Farber ON, Gomez GI, Titan AL, Fisher AT, Puntasecca CJ, Arana VT, Kempinsky A, Wise CE, Bessoff KE, Hawn MT, Korndorffer JR Jr, Forrester JD, Esquivel MM. Impact of COVID-19 on presentation, management, and outcomes of acute care surgery for gallbladder disease and acute appendicitis. World J Gastrointest Surg. 2021 Aug 27;13(8):859-870. doi: 10.4240/wjgs.v13.i8.859.
Results Reference
result
PubMed Identifier
34312724
Citation
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.
Results Reference
result
Links:
URL
http://www.mans.edu.eg/
Description
mansoura university
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.mans.edu.eg/
Available IPD/Information Identifier
COVID and acute appendicitis
Learn more about this trial
Presentation and Outcomes of Acute Appendicitis During COVID Pandemic
We'll reach out to this number within 24 hrs