Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Covid19 Appendicitis Cholecystitis, Acute Cholecystitis; Gallstone Cholecystitis Procedure: Operative management Procedure: Non-operative management Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
Actual Study Start Date : December 28, 2020
Estimated Primary Completion Date : June 28, 2021
Estimated Study Completion Date : September 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Active Comparator: Operative management
Treatment with surgery
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.

Active Comparator: Non-operative management
Treatment with antibiotics
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.





Primary Outcome Measures :
  1. Rate of pulmonary complications [ Time Frame: Up to 90 days ]
    Including pneumonia, acute respiratory distress syndrome (ARDS) or unexpected postoperative ventilation

  2. 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.

  3. Rate of pulmonary complications following non-operative management [ Time Frame: Up to 90 days ]
    Any intubation


Secondary Outcome Measures :
  1. Rate of post-intervention ICU admission [ Time Frame: Up to 90 days ]
    ICU admission following randomization

  2. Mortality (all cause) [ Time Frame: Up to 90 days ]
    Any death

  3. 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

  4. Median length of hospital stay [ Time Frame: Up to 90 days ]
    Cumulative and individual length of hospitalization(s)

  5. Rate of emergency room visits/readmission [ Time Frame: Up to 90 days ]

Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748120


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Layout table for investigator information
Principal Investigator: Clayton C Petro, MD Associate Professor of Surgery
Publications:
Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Giménez ME, de Santibañes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9. Review.

Layout table for additonal information
Responsible Party: Clayton Petro, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04748120    
Other Study ID Numbers: 20-525
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Appendicitis
Cholecystitis
Acalculous Cholecystitis
Gallstones
Cholecystitis, Acute
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Gallbladder Diseases
Biliary Tract Diseases
Cholelithiasis
Cholecystolithiasis
Calculi
Pathological Conditions, Anatomical