NCT04748120

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19
• Appendicitis
• Cholecystitis, Acute
• Cholecystitis; Gallstone
• Cholecystitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-28
• Primary completion: 2021-04-06
• Completion: 2021-04-06
• First posted: 2021-02-10
• Last updated: 2022-03-14
• Results posted: 2022-03-11

Locations

1 site across 1 country: United States