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NCT04748120

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

Terminated NA Results posted Last updated 14 March 2022
What this trial tests

NA trial testing Operative management in Covid19 in 2 participants. Terminated before completion.

Timeline
28 December 2020
Primary endpoint
6 April 2021
6 April 2021

Quick facts

Lead sponsorThe Cleveland Clinic
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment2
Start date28 December 2020
Primary completion6 April 2021
Estimated completion6 April 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Covid19 or Appendicitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Pulmonary Complications Primary · 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

GroupValue95% CI
Operative Management0
Non-operative Management0
Number of Participants With Post-intervention ICU Admission Secondary · Up to 90 days

ICU admission following randomization

GroupValue95% CI
Operative Management0
Non-operative Management0
Mortality (All Cause) Secondary · Up to 90 days

Any death

GroupValue95% CI
Operative Management0
Non-operative Management0
Complications as Measured by the Clavien-Dindo Classification Secondary · 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

GroupValue95% CI
Non-operative Management1
Median Length of Hospital Stay Secondary · Up to 90 days

Cumulative and individual length of hospitalization(s)

GroupValue95% CI
Operative Management44
Non-operative Management137
Number of Emergency Room Visits/Readmission Secondary · Up to 90 days
GroupValue95% CI
Operative Management0
Non-operative Management0
Number of Participants With Treatment Failure for Non-operative Management Secondary · Up to 90 days

Patients randomized to non-operative management who require non-elective surgery to remove the affected organ

GroupValue95% CI
Non-Operative Management0

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Systematic Review on the Contribution of Artificial Intelligence in the Development of Medicines for COVID-2019.
    Pires C. · · 2021 · cited 14× · PMID 34575703 · DOI 10.3390/jpm11090926
  2. Appendectomy versus antibiotic treatment for acute appendicitis.
    Doleman B, Fonnes S, Lund JN, Boyd-Carson H, et al · · 2024 · cited 9× · PMID 38682788 · DOI 10.1002/14651858.cd015038.pub2

Verify or expand the search:

Other trials of Operative management

Trials testing the same drug.

Other recruiting trials for Covid19

Currently open trials in the same condition.

Other The Cleveland Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04748120.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing