Clinical trial NCT05104346: Presentation and Outcomes of Acute Appendicitis During COVID Pandemic
Official title: Presentation and Outcomes of Acute Appendicitis During COVID Pandemic: Lessons Learned From the Middle East (Multicenter Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Appendicitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 1945
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

patients with acute appendicitis

Exclusion Criteria:

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

Primary outcomes:
measure: the management strategy used
timeFrame: one month
Secondary outcomes:
measure: clinical presentation
timeFrame: one month
measure: postoperative complications
timeFrame: one month
measure: the negative appendicectomy rate.
timeFrame: one month
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ayman El Nakeeb
Study officials:
affiliation: Mansoura University, Gastrointestinal Surgery Center
name: Ayman El E El Nakeeb
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.