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.
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.
Procedure: Operative management
Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.
Procedure: Non-operative management
Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:
Non-penicillin allergic patients
piperacillin/tazobactam 3.375g IV every 6 hours for 3 days
amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days
Penicillin allergic patients
ertapenem 1g IV every 24 hours for 3 days
ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days
Patients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.
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
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Clayton C Petro, MD, Principal Investigator
Associate Professor of Surgery