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Presentation and Outcomes of Acute Appendicitis During COVID Pandemic

NCT ID: NCT05104346

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1945 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2021-10-01

Brief Summary

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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

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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).

Conditions

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Acute Appendicitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Patients in group I (G1) had AA prior to the era of COVID

Patients in group I (G1) had AA prior to the era of COVID

Group Type PLACEBO_COMPARATOR

appendectomy

Intervention Type PROCEDURE

open or laparoscopic appendectomy

patients in group II (G2) had AA during COVID

patients in group II (G2) had AA during COVID

Group Type ACTIVE_COMPARATOR

appendectomy

Intervention Type PROCEDURE

open or laparoscopic appendectomy

Interventions

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appendectomy

open or laparoscopic appendectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

patients with acute appendicitis

Exclusion Criteria

* patients with acute appendicitis less than 12 years
* malignant appendix
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ayman El Nakeeb

Gastroenterology surgical center, mansoura university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman El E El Nakeeb

Role: PRINCIPAL_INVESTIGATOR

Mansoura University, Gastrointestinal Surgery Center

Locations

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Ayman El Nakeeb

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 34692596 (View on PubMed)

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.

Reference Type RESULT
PMID: 34700020 (View on PubMed)

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.

Reference Type RESULT
PMID: 34647160 (View on PubMed)

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.

Reference Type RESULT
PMID: 34568625 (View on PubMed)

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.

Reference Type RESULT
PMID: 34512909 (View on PubMed)

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.

Reference Type RESULT
PMID: 34312724 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Related Links

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http://www.mans.edu.eg/

mansoura university

Other Identifiers

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acute appendicitis (AA)

Identifier Type: -

Identifier Source: org_study_id