NCT04509986

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

August 11, 2020

Last Update Submit

August 11, 2020

Conditions

SurgeryCovid19Post-Op Complication

Outcome Measures

Primary Outcomes (1)

  • Post-operative mortality

    Mortality at 30 days after surgery

    30 days after surgery

Secondary Outcomes (4)

  • In-patient mortality

    30 days after surgery

  • Post-operative pulmonary complications

    30 days after surgery

  • Post-operative venous thromboembolism

    30 days after surgery

  • Post-operative complications

    30 days after surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing surgery done in an operating theatre by a surgeon.

You may qualify if:

  • 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.

You may not qualify if:

  • Minor procedures (full list will be available in the protocol).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • NIHR Global Health Research Unit on Global Surgery; STARSurg Collaborative. A prognostic model for use before elective surgery to estimate the risk of postoperative pulmonary complications (GSU-Pulmonary Score): a development and validation study in three international cohorts. Lancet Digit Health. 2024 Jul;6(7):e507-e519. doi: 10.1016/S2589-7500(24)00065-7.

    PMID: 38906616DERIVED

  • 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.

    PMID: 34739137DERIVED

  • 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.

    PMID: 34739085DERIVED

  • 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.

    PMID: 34251685DERIVED

  • 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.

    PMID: 33761533DERIVED

MeSH Terms

Conditions

COVID-19Postoperative Complications

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Aneel Bhangu, PhD

CONTACT

+44 (0) 121 3718121aneel.bhangu@gmail.com

Dmitri Nepogodiev, Master

CONTACT

+44 (0) 121 3718121D.Nepogodiev@bham.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 12, 2020

Study Start

October 1, 2020

Primary Completion

October 31, 2020

Study Completion

December 1, 2020

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share