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Clinical Trials/NCT04419571
NCT04419571
Completed
Not Applicable

Emergency Laparotomies and Outcomes During the COVID-19 Pandemic - a Retrospective Cohort Study

Barking, Havering and Redbridge University Hospitals NHS Trust1 site in 1 country94 target enrollmentMarch 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Barking, Havering and Redbridge University Hospitals NHS Trust
Enrollment
94
Locations
1
Primary Endpoint
30-day mortality
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

NLR has previously been observed to correlate with complications in upper GI (1) and colorectal (2) surgery. The investigators sought to assess if a similar correlation can be identified in emergency general surgical patients and if the presence of suspected or confirmed COVID-19 may impact on this.

Given the heterogeneity of emergency general surgery the investigators therefore plan to perform a retrospective review of patients having emergency laparotomies only at a single NHS site during COVID-19 pandemic. Assessment of outcomes and Neutrophil:lymphocyte ratio as a predictor of outcomes will be completed. Outcomes will be completed in line with the recent COVIDSurg study criteria (3). The primary outcome is 30-day mortality. Secondary outcomes are 7-day mortality, re-operation, length of stay, post-operative respiratory failure, post-operative ARDS (Acute Respiratory Distress Syndrome), post-operative sepsis and ITU (Intensive Therapy Unit)/HDU (High Dependency Unit) admission.

Registry
clinicaltrials.gov
Start Date
March 23, 2020
End Date
June 16, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nader Habib Bedwani

Doctor

Barking, Havering and Redbridge University Hospitals NHS Trust

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing emergency laparotomy (change made due to heterogeneity of emergency general surgery)

Exclusion Criteria

  • Inherited or acquired immunodeficiency (which may directly skew NLR)

Outcomes

Primary Outcomes

30-day mortality

Time Frame: 30 days

Mortality

Secondary Outcomes

  • Number of participants returning to theatre(30 days)
  • Length of stay(30 days)
  • Post-operative respiratory failure(30 days)
  • Post-operative ARDS(30 days)
  • ITU/HDU admission(30 days)
  • 7-day mortality(7 days)
  • Post-operative sepsis(30 days)

Study Sites (1)

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