Back to resultsOperative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
Primary Purpose
Covid19, Appendicitis, Cholecystitis, Acute
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Operative management
Non-operative management
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- COVID-19 confirmed positive by a microbiologic test.
- Mild COVID-19 - no or mild pneumonia
EITHER
- Uncomplicated acute appendicitis without a fecalith OR
- 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.
- Murphy's sign
- RUQ mass/pain/tenderness B. Systemic signs of inflammation etc.
- Fever
- elevated CRP
- 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:
- Persistent dyspnea
- Persistent respiratory frequency >30/min
- Persistent blood oxygen saturation <93%
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300
- 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
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Operative management
Non-operative management
Arm Description
Treatment with surgery
Treatment with antibiotics
Outcomes
Primary Outcome Measures
Number of Participants With Pulmonary Complications
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
Number of Participants With Post-intervention ICU Admission
ICU admission following randomization
Mortality (All Cause)
Any death
Complications as Measured by the Clavien-Dindo Classification
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
Median Length of Hospital Stay
Cumulative and individual length of hospitalization(s)
Number of Emergency Room Visits/Readmission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04748120
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient eligible patients
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
April 6, 2021 (Actual)
Study Completion Date
April 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Appendicitis, Cholecystitis, Acute, Cholecystitis; Gallstone, Cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a prospective, non-blinded, pilot randomized controlled trial comparing operative to non-operative management of acute appendicitis and acute cholecystitis in patients with mild to moderate COVID-19 infection. This will be a two-arm trial with intervention 1: intervention 2 allocation ratio of 1:1.
Masking
None (Open Label)
Masking Description
Participants will be informed regarding the treatment they receive at the time of randomization.
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Operative management
Arm Type
Active Comparator
Arm Description
Treatment with surgery
Arm Title
Non-operative management
Arm Type
Active Comparator
Arm Description
Treatment with antibiotics
Intervention Type
Procedure
Intervention Name(s)
Operative management
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-operative management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Pulmonary Complications
Description
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
Time Frame
Up to 90 days
Secondary Outcome Measure Information:
Title
Number of Participants With Post-intervention ICU Admission
Description
ICU admission following randomization
Time Frame
Up to 90 days
Title
Mortality (All Cause)
Description
Any death
Time Frame
Up to 90 days
Title
Complications as Measured by the Clavien-Dindo Classification
Description
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
Time Frame
Up to 90 days
Title
Median Length of Hospital Stay
Description
Cumulative and individual length of hospitalization(s)
Time Frame
Up to 90 days
Title
Number of Emergency Room Visits/Readmission
Time Frame
Up to 90 days
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment Failure for Non-operative Management
Description
Patients randomized to non-operative management who require non-elective surgery to remove the affected organ
Time Frame
Up to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COVID-19 confirmed positive by a microbiologic test.
Mild COVID-19 - no or mild pneumonia
EITHER
Uncomplicated acute appendicitis without a fecalith OR
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.
Murphy's sign
RUQ mass/pain/tenderness B. Systemic signs of inflammation etc.
Fever
elevated CRP
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:
Persistent dyspnea
Persistent respiratory frequency >30/min
Persistent blood oxygen saturation <93%
Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clayton C Petro, MD
Organizational Affiliation
Associate Professor of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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32091533
Citation
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Results Reference
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Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
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