Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-25 @ 4:20 AM
NCT ID:
NCT04748120
Eligibility Criteria:
Inclusion Criteria:
* COVID-19 confirmed positive by a microbiologic test.
* Mild COVID-19 - no or mild pneumonia
* EITHER
1. Uncomplicated acute appendicitis without a fecalith OR
2. 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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1. Murphy's sign
2. RUQ mass/pain/tenderness B. Systemic signs of inflammation etc.
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1. Fever
2. elevated CRP
3. elevated WBC count C. Imaging findings characteristic of acute cholecystitis
Exclusion Criteria:
* 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:
1. Persistent dyspnea
2. Persistent respiratory frequency \>30/min
3. Persistent blood oxygen saturation \<93%
4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300
5. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04748120
Study Brief:
Protocol Section:
NCT04748120