GlobalSurg-CovidSurg Week

Covid19 Clinical Trial

Official title:

GlobalSurg-CovidSurg Week: Determining the Optimal Timing for Surgery Following SARS-CoV-2 Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04509986
• Other study ID #: GS-CSWeek.20200713
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: August 2020
• Source: University of Birmingham
• Contact: Aneel Bhangu, PhD
• Phone: +44 (0) 121 3718121
• Email: aneel.bhangu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Covid19
• Post-Op Complication
• Postoperative Complications
• Surgery

Locations

Country	Name	City	State
n/a

Sponsors (12)

Lead Sponsor

Collaborator

University of Birmingham

Association of Coloproctology of Great Britain and Ireland, Association of Upper Gastrointestinal Surgeons; British Association of Surgical Oncology, Bowel & Cancer Research, Bowel Disease Research Foundation, British Gynaecological Cancer Society, European Society of Coloproctology, National Institute for Health Research (NIHR) Global Health Research Unit Grant (NIHR 16.136.79), NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, Yorkshire Cancer Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative mortality	Mortality at 30 days after surgery	30 days after surgery
Secondary	In-patient mortality	Mortality while the patient is admitted to hospital	30 days after surgery
Secondary	Post-operative pulmonary complications	30-day postoperative pulmonary complications (pneumonia [CDC definition], ARDS, unexpected ventilation)	30 days after surgery
Secondary	Post-operative venous thromboembolism	30-day venous thromboembolism (deep vein thrombosis/ pulmonary embolism)	30 days after surgery
Secondary	Post-operative complications	30-day Clavien-Dindo grade	30 days after surgery