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Completed

NCT Number: NCT04419571

Outcomes in Emergency Laparotomies During COVID-19 Pandemic

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Emergency General Surgery Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen's Hospital

Romford, RM7 0AG, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Emergency laparotomy

Procedure

All adult patients undergoing emergency laparotomy

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days

    Mortality

Secondary outcomes

  1. 7-day mortality

    Time frame: 7 days

    Mortality

  2. Number of participants returning to theatre

    Time frame: 30 days

    Re-operation

  3. Length of stay

    Time frame: 30 days

    Inpatient stay during index admission

  4. Post-operative respiratory failure

    Time frame: 30 days

    Presence of respiratory failure in the post-operative period as defined in the clinical notes or discharge summaries

  5. Post-operative ARDS

    Time frame: 30 days

    ARDS diagnosed radiologically

  6. Post-operative sepsis

    Time frame: 30 days

    Presence of sepsis in the post-operative period as defined in the clinical notes or discharge summaries

  7. ITU/HDU admission

    Time frame: 30 days

    ITU/HDU admission post-operatively

Other outcomes

  1. Other complications

    Time frame: 30 days

    Other documented post-operative complications

  2. Peri-operative NLR

    Time frame: First 3 post-operative days

    Neutrophil:Lymphocyte Ratio will be recorded daily in the peri-operative period

  3. Post-operative platelet counts

    Time frame: First 3 post-operative days

    Absolute platelet counts recorded daily in the peri-operative period

  4. Post-operative coagulopathy

    Time frame: First 3 post-operative days

    Defined as the presence of increased PT (prothrombin time) OR APTT (activated partial thromboplastin time) OR TT (thrombin time) OR fibrinogen above 1.5X the upper limit of normal. Coagulation will either be defined as normal or abnormal for each patient if one or more of these derangement are identified.

Sponsors and collaborators

Lead sponsor

Barking, Havering and Redbridge University Hospitals NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 5, 2020
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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