GlobalSurg-CovidSurg Week

• ClinicalTrials.gov Identifier: NCT04509986
• Recruitment Status: Unknown
• First Posted: August 12, 2020
• Last Update Posted: August 12, 2020
• Sponsor: University of Birmingham
• 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; NIHR Academy; Sarcoma UK; Vascular Society for Great Britain and Ireland; Yorkshire Cancer Research
• Information provided by (Responsible Party): University of Birmingham

Tracking Information

• First Submitted Date: August 11, 2020
• First Posted Date: August 12, 2020
• Last Update Posted Date: August 12, 2020
• Estimated Study Start Date: October 1, 2020
• Estimated Primary Completion Date: October 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2020)

Post-operative mortality [ Time Frame: 30 days after surgery ]

Mortality at 30 days after surgery

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 11, 2020)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: GlobalSurg-CovidSurg Week
• Official Title: GlobalSurg-CovidSurg Week: Determining the Optimal Timing for Surgery Following SARS-CoV-2 Infection
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All patients undergoing surgery done in an operating theatre by a surgeon.

Condition

• Surgery
• Covid19
• Post-Op Complication

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 11, 2020): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2020
• Estimated Primary Completion Date: October 31, 2020 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04509986
• Other Study ID Numbers: GS-CSWeek.20200713
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Birmingham
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Birmingham
• Original Study Sponsor: Same as current

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
• NIHR Academy
• Sarcoma UK
• Vascular Society for Great Britain and Ireland
• Yorkshire Cancer Research

• Investigators: Not Provided
• PRS Account: University of Birmingham
• Verification Date: August 2020