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|ClinicalTrials.gov Identifier: NCT04509986|
Recruitment Status : Unknown
Verified August 2020 by University of Birmingham.
Recruitment status was: Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
- Study Details
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|Condition or disease|
|Surgery Covid19 Post-Op Complication|
- 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|
|Estimated Enrollment :||1000 participants|
|Official Title:||GlobalSurg-CovidSurg Week: Determining the Optimal Timing for Surgery Following SARS-CoV-2 Infection|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||December 1, 2020|
- Post-operative mortality [ Time Frame: 30 days after surgery ]Mortality at 30 days after surgery
- In-patient mortality [ Time Frame: 30 days after surgery ]Mortality while the patient is admitted to hospital
- Post-operative pulmonary complications [ Time Frame: 30 days after surgery ]30-day postoperative pulmonary complications (pneumonia [CDC definition], ARDS, unexpected ventilation)
- Post-operative venous thromboembolism [ Time Frame: 30 days after surgery ]30-day venous thromboembolism (deep vein thrombosis/ pulmonary embolism)
- Post-operative complications [ Time Frame: 30 days after surgery ]30-day Clavien-Dindo grade
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
Minor procedures (full list will be available in the protocol).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509986
|Contact: Aneel Bhangu, PhD||+44 (0) 121 firstname.lastname@example.org|
|Contact: Dmitri Nepogodiev, Master||+44 (0) 121 3718121||D.Nepogodiev@bham.ac.uk|
|Responsible Party:||University of Birmingham|
|Other Study ID Numbers:||
|First Posted:||August 12, 2020 Key Record Dates|
|Last Update Posted:||August 12, 2020|
|Last Verified:||August 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|