Clinical trial NCT04509986: GlobalSurg-CovidSurg Week
Official title: GlobalSurg-CovidSurg Week: Determining the Optimal Timing for Surgery Following SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Covid19
Post-Op Complication
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research (NIHR) Global Health Research Unit Grant (NIHR 16.136.79)
name: Association of Coloproctology of Great Britain and Ireland
name: Bowel & Cancer Research
name: Association of Upper Gastrointestinal Surgeons; British Association of Surgical Oncology
name: Bowel Disease Research Foundation
name: British Gynaecological Cancer Society
name: European Society of Coloproctology
name: NIHR Academy
name: Sarcoma UK
name: Vascular Society for Great Britain and Ireland
name: Yorkshire Cancer Research
First posted: 2020-08-12
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing surgery done in an operating theatre by a surgeon.

Brief summary: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Post-operative mortality
timeFrame: 30 days after surgery
Secondary outcomes:
measure: In-patient mortality
timeFrame: 30 days after surgery
measure: Post-operative pulmonary complications
timeFrame: 30 days after surgery
measure: Post-operative venous thromboembolism
timeFrame: 30 days after surgery
measure: Post-operative complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.