SurgeryNCT04509986
GlobalSurg-CovidSurg Week
An observational study of Surgery and Covid19, run by University of Birmingham.
Trial summary
Observational study to determine the optimal timing for surgery following SARS-CoV-2 infection and assess key global surgery indicators. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Covid19, Post-Op Complication
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing surgery done in an operating theatre by a surgeon.
Who may be able to join
- 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.
Who cannot join
- Minor procedures (full list will be available in the protocol).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery, Covid19, Post-Op Complication
- Medical subject headings
- COVID-19, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative mortality
Mortality at 30 days after surgery
Measured: 30 days after surgery
Secondary outcomes (4)
In-patient mortality
Mortality while the patient is admitted to hospital
Measured: 30 days after surgery
Post-operative pulmonary complications
30-day postoperative pulmonary complications (pneumonia [CDC definition], ARDS, unexpected ventilation)
Measured: 30 days after surgery
Post-operative venous thromboembolism
30-day venous thromboembolism (deep vein thrombosis/ pulmonary embolism)
Measured: 30 days after surgery
Post-operative complications
30-day Clavien-Dindo grade
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research (NIHR) Global Health Research Unit Grant (NIHR 16.136.79), Association of Coloproctology of Great Britain and Ireland, Bowel & Cancer Research, Association of Upper Gastrointestinal Surgeons; British Association of Surgical Oncology, Bowel Disease Research Foundation, British Gynaecological Cancer Society, European Society of Coloproctology, National Institute for Health Research, United Kingdom, Sarcoma UK, Vascular Society for Great Britain and Ireland, Yorkshire Cancer Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509986
- Sponsor's protocol ID
- GS-CSWeek.20200713
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
NIHR Global Health Research Unit on Global Surgery; STARSurg Collaborative. A prognostic model for use before elective surgery to estimate the risk of postoperative pulmonary complications (GSU-Pulmonary Score): a development and validation study in three international cohorts. Lancet Digit Health. 2024 Jul;6(7):e507-e519. doi: 10.1016/S2589-7500(24)00065-7.
PubMed 38906616Glasbey 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.
PubMed 34739137Nepogodiev 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.
PubMed 34739085Lobo 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.
PubMed 34251685COVIDSurg 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.
PubMed 33761533
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlobalSurg-CovidSurg Week: Determining the Optimal Timing for Surgery Following SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04509986
- Acronym / sponsor ID
- GS-CSWeek.20200713
- Conditions
- Surgery, Covid19, Post-Op Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research (NIHR) Global Health Research Unit Grant (NIHR 16.136.79), Association of Coloproctology of Great Britain and Ireland, Bowel & Cancer Research, Association of Upper Gastrointestinal Surgeons; British Association of Surgical Oncology, Bowel Disease Research Foundation, British Gynaecological Cancer Society, European Society of Coloproctology, National Institute for Health Research, United Kingdom, Sarcoma UK, Vascular Society for Great Britain and Ireland, Yorkshire Cancer Research
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study to determine the optimal timing for surgery following SARS-CoV-2 infection and assess key global surgery indicators.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing surgery done in an operating theatre by a surgeon.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Minor procedures (full list will be available in the protocol).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-operative mortality
Time frame: 30 days after surgery
Mortality at 30 days after surgery
4 secondary outcomes
In-patient mortality
Time frame: 30 days after surgery
Post-operative pulmonary complications
Time frame: 30 days after surgery
Post-operative venous thromboembolism
Time frame: 30 days after surgery
Post-operative complications
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Derived from this study: PubMed 38906616NIHR Global Health Research Unit on Global Surgery; STARSurg Collaborative. A prognostic model for use before elective surgery to estimate the risk of postoperative pulmonary complications (GSU-Pulmonary Score): a development and validation study in three international cohorts. Lancet Digit Health. 2024 Jul;6(7):e507-e519. doi: 10.1016/S2589-7500(24)00065-7.
- Derived from this study: PubMed 34739137Glasbey 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.
- Derived from this study: PubMed 34739085Nepogodiev 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.
- Derived from this study: PubMed 34251685Lobo 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.
- Derived from this study: PubMed 33761533COVIDSurg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Covid19, run by University of Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aneel Bhangu, PhD (+44 (0) 121 3718121, aneel.bhangu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative mortality (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509986, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.