Outcomes in Emergency Laparotomies During COVID-19 Pandemic

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19, Emergency General Surgery

Intervention / Treatment
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* Procedure: Emergency Laparotomy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected or Confirmed COVID-19<br>All adult patients (>17 years) undergoing emergency (laparotomy) surgery at a single centre (Queens Hospital, Romford, UK) with clinically or radiologically suspected COVID-19, or with viral PCR confirmation; diagnosis made 7-days before and 30-days after date of surgery in accordance with the COVIDsurg study criteria (3). | Procedure: Emergency Laparotomy<br>* All adult patients undergoing emergency laparotomy<br>|
| Negative or non-suspected COVID-19<br>All adult patients (>17 years) undergoing emergency (laparotomy) surgery at a single centre (Queens Hospital, Romford, UK) without clinically or radiologically suspected COVID-19, or without viral PCR (Polymerase Chain Reaction) confirmation. | Procedure: Emergency Laparotomy<br>* All adult patients undergoing emergency laparotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Mortality | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day mortality | Mortality | 7 days | 
| Number of participants returning to theatre | Re-operation | 30 days | 
| Length of stay | Inpatient stay during index admission | 30 days | 
| Post-operative respiratory failure | Presence of respiratory failure in the post-operative period as defined in the clinical notes or discharge summaries | 30 days | 
| Post-operative ARDS | ARDS diagnosed radiologically | 30 days | 
| Post-operative sepsis | Presence of sepsis in the post-operative period as defined in the clinical notes or discharge summaries | 30 days | 
| ITU/HDU admission | ITU/HDU admission post-operatively | 30 days |