GlobalSurg-CovidSurg Week

August 11, 2020 updated by: University of Birmingham

GlobalSurg-CovidSurg Week: Determining the Optimal Timing for Surgery Following SARS-CoV-2 Infection

Observational study to determine the optimal timing for surgery following SARS-CoV-2 infection and assess key global surgery indicators.

Study Overview

Status

Unknown

Detailed Description

  • Prospective, observational international cohort study.
  • Any hospital worldwide can participate (including hospitals that have not admitted SARS-CoV-2 infected patients).
  • All patients undergoing a surgical procedure in an operating theatre will be included. All consecutive eligible patients should be included.
  • 7-day data collection period, with follow-up at 30 days after surgery for each patient. However, no changes should be made to normal patient care/ follow-up pathways
  • Primary outcome is 30-day mortality.
  • All collaborators will be included as PubMed-citable co-authors on resulting publications.

Study Type

Observational

Enrollment (Anticipated)

1000

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

Study Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing surgery done in an operating theatre by a surgeon.

Description

Inclusion criteria

  • Any operation (elective or emergency) done in an operating theatre by a surgeon.
  • All surgical specialties including: acute care surgery, breast surgery, cardiac surgery, colorectal surgery, general surgery, gynaecology, hepatobiliary surgery, neurosurgery, obstetrics, oesophagogastric surgery, ophthalmology, oral and maxillofacial surgery, orthopaedics, otolaryngology, paediatric surgery, plastic surgery, thoracic surgery, transplant surgery, trauma surgery, urology, vascular surgery.
  • Day case surgery and inpatient surgery included.
  • Any SARS-CoV-2 status (positive at any time, negative, not tested).
  • All ages including children and adults.

Exclusion criteria:

Minor procedures (full list will be available in the protocol).

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
Post-operative mortality
Time Frame: 30 days after surgery
Mortality at 30 days after surgery
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-patient mortality
Time Frame: 30 days after surgery
Mortality while the patient is admitted to hospital
30 days after surgery
Post-operative pulmonary complications
Time Frame: 30 days after surgery
30-day postoperative pulmonary complications (pneumonia [CDC definition], ARDS, unexpected ventilation)
30 days after surgery
Post-operative venous thromboembolism
Time Frame: 30 days after surgery
30-day venous thromboembolism (deep vein thrombosis/ pulmonary embolism)
30 days after surgery
Post-operative complications
Time Frame: 30 days after surgery
30-day Clavien-Dindo grade
30 days after surgery

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

October 1, 2020

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-CSWeek.20200713

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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