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GlobalSurg-CovidSurg Week

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
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

Study Description
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Brief Summary:
Observational study to determine the optimal timing for surgery following SARS-CoV-2 infection and assess key global surgery indicators.

Condition or disease
Surgery Covid19 Post-Op Complication

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
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Post-operative mortality [ Time Frame: 30 days after surgery ]
    Mortality at 30 days after surgery


Secondary Outcome Measures :
  1. In-patient mortality [ Time Frame: 30 days after surgery ]
    Mortality while the patient is admitted to hospital

  2. Post-operative pulmonary complications [ Time Frame: 30 days after surgery ]
    30-day postoperative pulmonary complications (pneumonia [CDC definition], ARDS, unexpected ventilation)

  3. Post-operative venous thromboembolism [ Time Frame: 30 days after surgery ]
    30-day venous thromboembolism (deep vein thrombosis/ pulmonary embolism)

  4. Post-operative complications [ Time Frame: 30 days after surgery ]
    30-day Clavien-Dindo grade


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing surgery done in an operating theatre by a surgeon.
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).

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Aneel Bhangu, PhD +44 (0) 121 3718121 aneel.bhangu@gmail.com
Contact: Dmitri Nepogodiev, Master +44 (0) 121 3718121 D.Nepogodiev@bham.ac.uk

Sponsors and Collaborators
University of Birmingham
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT04509986    
Other Study ID Numbers: GS-CSWeek.20200713
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes