Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients

NeuroTherapia, Inc.

Status: Terminated

Conditions: Cholecystitis; Gallstone; Cholecystitis; Appendicitis; Cholecystitis, Acute; Covid19

Treatments: Procedure: Operative management; Procedure: Non-operative management

Study type: Interventional

Funder types: Other

Identifiers

NCT04748120

20-525

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Operative management

Active Comparator group

Description:

Treatment with surgery

Treatment:

Procedure: Operative management

Non-operative management

Active Comparator group

Description:

Treatment with antibiotics

Treatment:

Procedure: Non-operative management