Association Between Post-covid Infection Status and Perioperative Morbidity:A Ambispective Cohort Study.

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05689840
Collaborator
(none)
675
1.9

Study Details

Study Description

Brief Summary

With the knowledge of currently transmitted omicron variant being less virulent, over 90 percent of the Chinese population is fully vaccinated, and the Chinese health workers have sufficient experience treating the illness. China 's epidemic prevention and control has entered a new stage to restore the normal functioning of society and basic medical services, On Dec, 7, China released a circular on further optimizing its COVID-19 response, announcing 10 new prevention and control measures.This has marked the watershed for sharply increased number of elective surgical patients diagnosed with COVID-19 during preoperativley, fully recovered or during recovery.

Beijing faced a wave of omicron infection starting that would result in of a wide range of population infections. At which time there is limited evidence regarding the optimal timing of surgery following SARS-CoV-2 infection especially for omiron among Chinsese patients .This study intends to explore the relationship between the incidence of postoperative complications after elective surgery and COVID-19 infection in Peking Union Medical College Hospital, and provide data support for the policy formulation of elective surgical timing for patients after COVID-19 infection.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Receiving elective surgery

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
675 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Association Between Post-covid Infection Status and Perioperative Morbidity:A Ambispective Cohort Study.
Anticipated Study Start Date :
Jan 31, 2023
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Covid-19 infection group

Patients who have been infected with Covid-19 before elective surgery.

Procedure: Receiving elective surgery
Receiving elective surgery in Peking Union Medical College Hospital

Control group

Patients who were not infected with COVID-19 before elective surgery.

Procedure: Receiving elective surgery
Receiving elective surgery in Peking Union Medical College Hospital

Outcome Measures

Primary Outcome Measures

  1. Perioperative complications [The day of discharge]

    Perioperative complications include: Respiratory system complications: pneumonia, acute respiratory distress syndrome, pulmonary edema, postoperative hypoxia, atelectasis, pleural effusion, ventilator support ≥ 48 hours, etc; Cardiovascular complications: cardiac arrest, arrhythmia, new hypertension, new hypotension, heart failure, myocardial infarction, etc Digestive system complications: nausea and vomiting, intestinal obstruction, peritonitis, etc Neurological complications: cerebrovascular events (cerebral infarction, cerebral hemorrhage), delirium, etc Blood system complications: deep vein thrombosis, pulmonary embolism, massive hemorrhage, transfusion related adverse reactions, etc Urinary system complications: acute renal injury, urinary retention, urinary system infection, etc Others: surgical incision infection, blood flow infection, poor wound healing, etc

Secondary Outcome Measures

  1. Length of intensive care unit stay [The day of discharge]

    Calculate the number of days the patient stays in the intensive care unit after surgery.

Other Outcome Measures

  1. Length of hospital stay [The day of discharge]

    Calculate the number of days the patient stays in the hospital.

  2. Readmission rate during 30 days after surgery [30 days after operation]

    Readmission due to surgery complications during 30 days after operation

  3. Postoperative mechanical ventilation time [The day of discharge]

    Length of mechanical ventilation time after surgery

  4. Mortality within 30 days after operation [30 days after operation]

    Mortality within 30 days after operation

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Accept elective surgery in Peking Union Medical College Hospital.

  • Patients can understand the research protocol and are willing to participate in the research, and sign the informed consent form.

Exclusion Criteria:
  • Patients participating in other clinical studies.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05689840
Other Study ID Numbers:
  • K23C0257
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 19, 2023