Frequency of Perforated Appendicitis in Times of COVID-19

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT04472052

Collaborator

(none)

143

Enrollment

Location

2.5

Actual Duration (Months)

57.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Perforated Appendicitis Covid19	Other: appendectomy

Detailed 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

Study Design

Study Type:

Observational

Actual Enrollment :

143 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Incidence of Perforated Appendicitis in Times of Corona Crisis

Actual Study Start Date :

Mar 16, 2020

Actual Primary Completion Date :

May 31, 2020

Actual Study Completion Date :

May 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Appendectomy Patients who required appendectomy for suspected acute appendicitis	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.

Arm

Intervention/Treatment

Appendectomy

Patients who required appendectomy for suspected acute appendicitis

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.

Outcome Measures

Primary Outcome Measures

rate of perforated appendicitis [10 weeks from 16th of March to 31th of May]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Tuebingen	Tuebingen		Germany	72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT04472052

Other Study ID Numbers:

AZ: 324/2020BO2

First Posted:

Jul 15, 2020

Last Update Posted:

Jul 15, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital Tuebingen

acute appendicitis, COVID-19

Additional relevant MeSH terms:

COVID-19

Appendicitis

Study Results

No Results Posted as of Jul 15, 2020