- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509986
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
Conditions
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
- Name: Aneel Bhangu, PhD
- Phone Number: +44 (0) 121 3718121
- Email: aneel.bhangu@gmail.com
Study Contact Backup
- Name: Dmitri Nepogodiev, Master
- Phone Number: +44 (0) 121 3718121
- Email: D.Nepogodiev@bham.ac.uk
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.
Sponsor
Collaborators
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.
General Publications
- Glasbey J; COVIDSurg and GlobalSurg Collaboratives. Peri-operative outcomes of surgery in children with SARS-CoV-2 infection. Anaesthesia. 2022 Jan;77(1):108-109. doi: 10.1111/anae.15614. Epub 2021 Nov 5. No abstract available.
- Nepogodiev D; COVIDSurg and GlobalSurg Collaboratives. Timing of surgery following SARS-CoV-2 infection: country income analysis. Anaesthesia. 2022 Jan;77(1):111-112. doi: 10.1111/anae.15615. Epub 2021 Nov 5. No abstract available.
- Lobo D, Devys JM. Timing of surgery following SARS-CoV-2 infection: an international prospective cohort study. Anaesthesia. 2022 Jan;77(1):110. doi: 10.1111/anae.15540. Epub 2021 Jul 12. No abstract available.
- COVIDSurg Collaborative, GlobalSurg Collaborative. SARS-CoV-2 vaccination modelling for safe surgery to save lives: data from an international prospective cohort study. Br J Surg. 2021 Sep 27;108(9):1056-1063. doi: 10.1093/bjs/znab101.
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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