- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04472052
Frequency of Perforated Appendicitis in Times of COVID-19
Incidence of Perforated Appendicitis in Times of Corona Crisis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tuebingen, Germany, 72076
- University Hospital of Tuebingen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Appendectomy
Patients who required appendectomy for suspected acute appendicitis
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rate of perforated appendicitis
Time Frame: 10 weeks from 16th of March to 31th of May
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10 weeks from 16th of March to 31th of May
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Cecal Diseases
- Intraabdominal Infections
- COVID-19
- Appendicitis
Other Study ID Numbers
- AZ: 324/2020BO2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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