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

Not Applicable

Terminated

• Conditions: Appendicitis; Cholecystitis; Covid19; Cholecystitis, Acute; Cholecystitis; Gallstone
• Interventions: Procedure: Non-operative management; Procedure: Operative management

• Registration Number: NCT04748120
• Lead Sponsor: The Cleveland Clinic

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 Timeline

• Study Start: 2020-12-28
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-10
• Primary Completion: 2021-04-06
• Study Completion: 2021-04-06
• Results First Submitted: 2022-02-21
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-09
• Last Update Submitted: 2022-03-10
• Results First Posted: 2022-03-11
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-operative management	Non-operative management	Treatment with antibiotics
Operative management	Operative management	Treatment with surgery

Primary Outcome Measures

Name	Time	Method
Number of Participants With Pulmonary Complications	Up to 90 days	Including pneumonia, acute respiratory distress syndrome (ARDS) or unexpected postoperative ventilation; For operative management this means any episode of non-invasive ventilation, invasive ventilation, or extracorporeal membrane oxygenation after initial extubation after surgery, or patient cannot be extubated as planned after surgery.; For non-operative management this means any intubation

Secondary Outcome Measures

Name	Time	Method
Median Length of Hospital Stay	Up to 90 days	Cumulative and individual length of hospitalization(s)
Number of Participants With Post-intervention ICU Admission	Up to 90 days	ICU admission following randomization
Mortality (All Cause)	Up to 90 days	Any death
Number of Emergency Room Visits/Readmission	Up to 90 days
Complications as Measured by the Clavien-Dindo Classification	Up to 90 days	The Clavien-Dindo classification is a grading scale from 1 to 5 (with 5 being more severe0 to objectively describe the severity of a complication, including any deviation from the normal postoperative course

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States