Main Postoperative Complications After COVID-19

January 20, 2023 updated by: RenJi Hospital

Main Postoperative Complications After SARS-CoV-2 Infection: A Prospective Cohort Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients having elective or confine surgery in operating room

Description

Inclusion Criteria:

  • Age≥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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality at 30 days after operation
Time Frame: 30 days after surgery
All-cause mortality at 30 days after operation
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main pulmonary complications at 30 days after operation
Time Frame: 30 days after surgery
a composite of postoperative pneumonia, acute respiratory distress syndrome (ARDS) and unexpected ventilation
30 days after surgery
Major Adverse Cardiovascular Events (MACE)
Time Frame: 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)
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPOC-COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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