Brief Title
Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
Official Title
Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
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 patients with active mild to moderate COVID-19 infection. The hypothesis is
that COVID+ patients with uncomplicated acute appendicitis or acute cholecystitis amendable
to a laparoscopic procedure can have safe operative outcomes compared to those managed
non-operatively.
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. Currently, little is known regarding the true consequences of general anesthesia in
COVID-positive (COVID+) patients. Surgeons are going to face challenging decisions regarding
whether or not to operate for non-elective cases requiring general anesthesia when
non-operative treatment options exist. Patients with acute appendicitis are usually treated
with an operation to remove the appendix, but they can also be initially treated with
antibiotics and have an operation at a later date. Similarly, patients with acute
cholecystitis are usually treated with an operation to remove the gallbladder, but they can
be treated with antibiotics and a percutaneous cholecystostomy tube (a tube that going
through the skin to drain the gallbladder) and have an operation at a later date. However,
patients managed without a definitive operation may require more resource utilization, PPE
consumption, interactions with hospital personnel, and could experience treatment failures
that exacerbate their viral illness. This is a pilot study comparing the safety of operative
versus non-operative management of COVID+ patients with mild to moderate symptoms.
Study Type
Interventional
Primary Outcome
Number of Participants With Pulmonary Complications
Secondary Outcome
Number of Participants With Post-intervention ICU Admission
Condition
Covid19
Intervention
Operative management
Study Arms / Comparison Groups
Operative management
Description: Treatment with surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
2
Start Date
December 28, 2020
Completion Date
April 6, 2021
Primary Completion Date
April 6, 2021
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.
1. Murphy's sign
2. RUQ mass/pain/tenderness B. Systemic signs of inflammation etc.
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Clayton C Petro, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04748120
Organization ID
20-525
Responsible Party
Principal Investigator
Study Sponsor
The Cleveland Clinic
Study Sponsor
Clayton C Petro, MD, Principal Investigator, Associate Professor of Surgery
Verification Date
March 2022