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

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ClinicalTrials.gov Identifier: NCT04748120
Recruitment Status : Enrolling by invitation
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Clayton Petro, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE February 5, 2021
First Posted Date  ICMJE February 10, 2021
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE December 28, 2020
Estimated Primary Completion Date June 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Rate of pulmonary complications [ Time Frame: Up to 90 days ]
    Including pneumonia, acute respiratory distress syndrome (ARDS) or unexpected postoperative ventilation
  • Rate of pulmonary complications following operative management [ Time Frame: Up to 90 days ]
    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.
  • Rate of pulmonary complications following non-operative management [ Time Frame: Up to 90 days ]
    Any intubation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Rate of post-intervention ICU admission [ Time Frame: Up to 90 days ]
    ICU admission following randomization
  • Mortality (all cause) [ Time Frame: Up to 90 days ]
    Any death
  • Rate of all complications as measured by the Clavien-Dindo classification [ Time Frame: 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
  • Median length of hospital stay [ Time Frame: Up to 90 days ]
    Cumulative and individual length of hospitalization(s)
  • Rate of emergency room visits/readmission [ Time Frame: Up to 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 8, 2021)
Rate of treatment failure for non-operative management [ Time Frame: Up to 90 days ]
Patients randomized to non-operative management who require non-elective surgery to remove the affected organ
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
Official Title  ICMJE Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Appendicitis
  • Cholecystitis, Acute
  • Cholecystitis; Gallstone
  • Cholecystitis
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Active Comparator: Operative management
    Treatment with surgery
    Intervention: Procedure: Operative management
  • Active Comparator: Non-operative management
    Treatment with antibiotics
    Intervention: Procedure: Non-operative management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: February 8, 2021)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 28, 2021
Estimated Primary Completion Date June 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04748120
Other Study ID Numbers  ICMJE 20-525
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clayton Petro, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Clayton C Petro, MD Associate Professor of Surgery
PRS Account The Cleveland Clinic
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP