A Retrospective Cohort Study for Main Postoperative Complications After SARS-CoV-2 Infection

• Sponsor: RenJi Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05781581
• 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)
• Enrollment: 50,000
• Anticipated Duration (Months): 21.5

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
Intestines Cancer; Pulmonary Cancer; Liver Cancer; Trauma; Fractures, Bone; Gynecologic Disease	Other: no intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Main Postoperative Complications After SARS-CoV-2 Infection: A Retrospective Cohort Study
• Anticipated Study Start Date: Mar 19, 2023
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Dec 31, 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 cardiogenic death, myocardial infarction, new-onset heart failure or cardiogenic shock, 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:

• Age≥18 years;

• Patients undergoing any type of surgery in operating room.

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.

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: NCT05781581
• Other Study ID Numbers: retro-MPOC
• First Posted: Mar 23, 2023
• Last Update Posted: Mar 23, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Intestinal Neoplasms; Lung Neoplasms; Postoperative Complications; Fractures, Bone

Study Results

No Results Posted as of Mar 23, 2023