NCT05104346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,945

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

October 31, 2021

Last Update Submit

November 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • the management strategy used

    the management strategy used, which included conservative or surgical management (open or laparoscopic).

    one month

Secondary Outcomes (3)

  • clinical presentation

    one month

  • postoperative complications

    one month

  • the negative appendicectomy rate.

    one month

Study Arms (2)

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

PLACEBO COMPARATOR

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

Procedure: appendectomy

patients in group II (G2) had AA during COVID

ACTIVE COMPARATOR

patients in group II (G2) had AA during COVID

Procedure: appendectomy

Interventions

appendectomyPROCEDURE

open or laparoscopic appendectomy

Patients in group I (G1) had AA prior to the era of COVIDpatients in group II (G2) had AA during COVID

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with acute appendicitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman El Nakeeb

Al Mansurah, 335111, Egypt

Location

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ayman El E El Nakeeb

    Mansoura University, Gastrointestinal Surgery Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterology surgical center, mansoura university

Study Record Dates

First Submitted

October 31, 2021

First Posted

November 3, 2021

Study Start

March 31, 2019

Primary Completion

March 31, 2021

Study Completion

October 1, 2021

Last Updated

November 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

the study protocol will be available for other researcher

Shared Documents
STUDY PROTOCOL
Time Frame
available for any researcher at any time
Access Criteria
elnakeebayman@yahoo.com
More information

Available IPD Datasets

Study Protocol (COVID and acute appendicitis)Access

Locations