Frequency of Perforated Appendicitis in Times of COVID-19

Covid19 Clinical Trial

Official title:

Incidence of Perforated Appendicitis in Times of Corona Crisis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472052
• Other study ID #: AZ: 324/2020BO2
• Status: Completed
• Start date: March 16, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2020
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Appendicitis is one of the most common clinical conditions in general surgery. The diagnosis is usually made from clinical examination, imaging (sonography or CT) and laboratory parameters. The laparoscopic appendectomy without drainage has established as the gold standard. Patients usually leave the hospital two days after surgery.

In times of corona crisis, patients are unsure to visit the hospital because of fear of infection with SARS-CoV-2. A higher incidence of perforated appendicitis could be an indicator for fear-related delay of going to the hospital.

Methods: Investigators performed a retrospective analysis on the incidence of perforated appendicitis in a 10-week interval (mid-March to end of May) of the years 2018, 2019 and 2020 to evaluate possible changes in times of corona crisis. Intraoperative findings, procedures, complications and the length of hospital stay were considered.

Description:

The local ethics committee of the University Hospital of Tübingen, Germany, approved this study (AZ: 324/2020BO2). All patients treated for acute appendicitis in a ten week period from 16th of March to 31th of May in 2018, 2019 and 2020 were considered for the study. Investigators analysed the frequency of perforated appendicitis in the periods indicated. Informed consent was obtained from all individual participants. Patient's records as well as database were analyzed for therapy specific items.

Definition Perforation: Perforated appendicitis was defined as described perforation in the surgical or pathological results.

Delay between onset of symptoms and first presentation at the hospital: Patient's records were proved for self-declaration about the start of symptoms

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• patients with acute appendicitis older than 16 years

• appendectomy in time frame 16th of march to 30th of May in the Years 2018, 2019 and 2020

Exclusion Criteria:

• patients with acute appendicitis younger than 16 years

• appendectomy not in the named time frames

Related Conditions & MeSH terms

• Appendicitis
• Covid19
• Perforated Appendicitis

Intervention

Other:
• appendectomy
Surgical standard treatment for acute appendicitis All patients receive preoperative single-shot antibiosis, usually 2000 mg cefotaxime combined 500 mg metronidazole. Appendectomy is performed usually within 24 h of admission in patients with acute appendicitis. The laparoscopic appendectomy using the 3-trocar technique represents the surgical standard. In uncomplicated or non-perforated appendicitis, drainage is generally not required. Wounds are closed intra-cutaneous with absorbable sutures. Patients without postoperative complications are discharged home two days after surgery.

Locations

Country	Name	City	State
Germany	University Hospital of Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of perforated appendicitis		10 weeks from 16th of March to 31th of May