Main Postoperative Complications After COVID-19

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05694949
Collaborator
The First Affiliated Hospital of Anhui Medical University (Other), First Affiliated Hospital of Chongqing Medical University (Other), Sichuan Academy of Medical Sciences (Other), Second Hospital of Shanxi Medical University (Other)
100,000
12

Study Details

Study Description

Brief Summary

To explore the relationship between SARS-CoV-2 infection in different time before operation and postoperative main complications (mortality, main pulmonary and cardiovascular complications) 30 days after operation; To determine the best timing of surgery after SARS-CoV-2 infection.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Main Postoperative Complications After SARS-CoV-2 Infection: A Prospective Cohort Study
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    Feb 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality at 30 days after operation [30 days after surgery]

      All-cause mortality at 30 days after operation

    Secondary Outcome Measures

    1. Main pulmonary complications at 30 days after operation [30 days after surgery]

      a composite of postoperative pneumonia, acute respiratory distress syndrome (ARDS) and unexpected ventilation

    2. Major Adverse Cardiovascular Events (MACE) [30 days after surgery]

      a composite of myocardial infarction, new-onset heart failure or cardiogenic shock, deep vein thrombosis (DVT), pulmonary embolism (PE), and cerebrovascular accident (CVA)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Ageā‰„18 years;

    • Patients undergoing any type of elective or confine surgery in operating room;

    • Informed consent.

    Exclusion Criteria:
    • Surgery under local anesthesia (without participation of anesthetist)

    • Surgery outside the operating room, such as gastrointestinal endoscopy, puncture biopsy, etc

    • Patients who cannot determine whether they have had SARS CoV-2 infection before surgery

    • Participating in conflicting clinical study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital
    • The First Affiliated Hospital of Anhui Medical University
    • First Affiliated Hospital of Chongqing Medical University
    • Sichuan Academy of Medical Sciences
    • Second Hospital of Shanxi Medical University

    Investigators

    • Study Chair: Diansan Su, MD,PHD, Renji Hospital, Shanghai Jiaotong University, School of Medcine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05694949
    Other Study ID Numbers:
    • MPOC-COVID-19
    First Posted:
    Jan 23, 2023
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 25, 2023