Status:
TERMINATED
Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
Lead Sponsor:
The Cleveland Clinic
Conditions:
Covid19
Appendicitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study evaluates operative and non-operative management of acute appendicitis (infection or inflammation of the appendix) and acute cholecystitis (inflammation/infection of the gallbladder) in pat...
Detailed Description
As the novel coronavirus disease 2019 (COVID-19) disseminates across the United States, more routine preoperative testing is going to expose infected patients with no or mild pneumonia symptoms. Curre...
Eligibility Criteria
Inclusion
- COVID-19 confirmed positive by a microbiologic test.
- Mild COVID-19 - no or mild pneumonia
- EITHER
- Uncomplicated acute appendicitis without a fecalith OR
- Acute cholecystitis - by TG18/TG13 diagnostic criteria where definite diagnosis requires one item in A + one item in B + C A. Local signs of inflammation etc.
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- Murphy's sign
- RUQ mass/pain/tenderness B. Systemic signs of inflammation etc.
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- Fever
- elevated CRP
- elevated WBC count C. Imaging findings characteristic of acute cholecystitis
Exclusion
- Active pregnancy
- COVID-19 severe disease that would be a contraindication to operative intervention at the discretion of the attending surgeon supported by the following, none of which are individually required or are a strict exclusion criterion as some of these could be attributed or exacerbated by the underlying surgical problem:
- Persistent dyspnea
- Persistent respiratory frequency \>30/min
- Persistent blood oxygen saturation \<93%
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300
- Lung infiltrates \>50%
- COVID-19 critical disease - respiratory failure, shock, or multiorgan dysfunction
- The surgeon expects increased operative complexity - high risk of conversion to open or prolonged procedure
- Unable or unwilling to consent or fulfill study procedures - need to complete 90 day follow-up by telephone
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04748120
Start Date
December 28 2020
End Date
April 6 2021
Last Update
March 14 2022
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195