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NCT05104346 Clinical Trial

Presentation and Outcomes of Acute Appendicitis During COVID Pandemic

Acute Appendicitis Clinical Trial

— AA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05104346
Other study ID # acute appendicitis (AA)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2019
Est. completion date October 1, 2021

Study information
Verified date November 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 1945
Est. completion date October 1, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: patients with acute appendicitis Exclusion Criteria: - patients with acute appendicitis less than 12 years - malignant appendix

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• appendectomy
open or laparoscopic appendectomy

Locations
Country Name City State
Egypt Ayman El Nakeeb Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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: 10.1 — View 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 — View 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. — View Citation

Köhler F, Müller 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 Oct 23;95:106148. doi: 10 — View 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. 2021 Jul 26. doi: 10.1007/s00464-021-08667-9. [Epub ahead of print] — View 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. 2021 Oct 13. doi: 10.1007/s00384-021-04031-4. [Epub ahead of print] — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary the management strategy used the management strategy used, which included conservative or surgical management (open or laparoscopic). one month
Secondary clinical presentation Alverado score from 1 to 10 the worst score is 10 one month
Secondary postoperative complications postoperative complications have been classified by Dindo G1 TO G5 one month
Secondary the negative appendicectomy rate. This is normal appendix after appendectomy one month
See also
  Status Clinical Trial Phase
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Completed NCT04649996 - Variation in Acute Appendicitis During COVID-19 Pandemic in Italy
Completed NCT04387370 - The Use of the Hem-o-lok Clip in Appendectomy: Single or Double?
Completed NCT04030741 - Non-operative Treatment of Acute Non-perforated Appendicitis Phase 2/Phase 3
Recruiting NCT04860570 - Are Double-ring Wound-edge Protectors Effective for Preventing Superficial Surgical Site Infection After Open Appendectomy?
Withdrawn NCT05724628 - Non-operative vs. Operative Management of Acute Appendicitis in Vulnerable Patient Populations Phase 1
Completed NCT01024439 - Transumbilical Single Incision Versus Conventional Three Incisions Laparoscopic Appendicectomy N/A
Completed NCT02714023 - Water And Saline Head-to-head In The Blinded Evaluation Study Trial N/A
Active, not recruiting NCT03324165 - Comparing Proposed Algorithm and Current Practice in the Evaluation of Suspected Appendicitis N/A
Active, not recruiting NCT01022567 - Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis N/A
Not yet recruiting NCT06059365 - Clinical Trial for a Outpatient Clinical Management for Complicated Acute Appendicitis N/A
Not yet recruiting NCT06051825 - Diagnostic Importance of the C-reactive Protein From Blood and Saliva in Children With Acute Appendicitis
Recruiting NCT04947748 - Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous N/A
Completed NCT04615728 - MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC
Terminated NCT04207645 - Modification and Validation of the RIPASA Score for Diagnosis of Acute Appendicitis
Not yet recruiting NCT02789865 - Clinical Trial Comparing ERAT vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis Phase 2
Completed NCT02731924 - Point of Care Ultrasound for Evaluation of Suspected Appendicitis in the Emergency Department
Completed NCT03886896 - Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy Phase 4
Not yet recruiting NCT01720082 - Laparoscopic Appendectomy by Multi-port vs Single Port. Phase 3
Completed NCT01348464 - A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy N/A

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