Outcomes in Emergency Laparotomies During COVID-19 Pandemic

Completed

• Conditions: Emergency General Surgery; COVID-19
• Interventions: Procedure: Emergency Laparotomy

• Registration Number: NCT04419571
• Lead Sponsor: Barking, Havering and Redbridge University Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-23
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-05
• Primary Completion: 2020-06-16
• Study Completion: 2020-06-16
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative or non-suspected COVID-19	Emergency Laparotomy	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.
Suspected or Confirmed COVID-19	Emergency Laparotomy	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).

Primary Outcome Measures

Name	Time	Method
30-day mortality	30 days	Mortality

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Queen's Hospital; 🇬🇧 Romford, United Kingdom