Outcomes in Emergency Laparotomies During COVID-19 Pandemic

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Emergency General Surgery
• Intervention / Treatment: Procedure: Emergency Laparotomy

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• United Kingdom
  • Romford, United Kingdom, RM7 0AG
    • Queen's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients (>17 years) undergoing emergency (laparotomy) surgery at a single centre (Queens Hospital, Romford, UK) regardless of COVID-19 status will be included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected or Confirmed COVID-19; 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; All adult patients undergoing emergency laparotomy
Negative or non-suspected COVID-19; 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; All adult patients undergoing emergency laparotomy

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other complications	Other documented post-operative complications	30 days
Peri-operative NLR	Neutrophil:Lymphocyte Ratio will be recorded daily in the peri-operative period	First 3 post-operative days
Post-operative platelet counts	Absolute platelet counts recorded daily in the peri-operative period	First 3 post-operative days
Post-operative coagulopathy	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.	First 3 post-operative days

Collaborators and Investigators

• Sponsor: Barking, Havering and Redbridge University Hospitals NHS Trust

Publications and helpful links

General Publications

• Vulliamy P, McCluney S, Mukherjee S, Ashby L, Amalesh T. Postoperative Elevation of the Neutrophil: Lymphocyte Ratio Predicts Complications Following Esophageal Resection. World J Surg. 2016 Jun;40(6):1397-403. doi: 10.1007/s00268-016-3427-z.
• Cook EJ, Walsh SR, Farooq N, Alberts JC, Justin TA, Keeling NJ. Post-operative neutrophil-lymphocyte ratio predicts complications following colorectal surgery. Int J Surg. 2007 Feb;5(1):27-30. doi: 10.1016/j.ijsu.2006.05.013. Epub 2006 Jun 27.

Helpful Links

• CovidSurg Cohort Study. Globalsurg.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Actual): June 16, 2020
• Study Completion (Actual): June 16, 2020

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Emergencies
• Other Study ID Numbers: 133196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected IPD regardless of inclusion in final publication
• IPD Sharing Time Frame: Data will be available from completion of study for 10 years
• IPD Sharing Access Criteria: On request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 285260
   Information comments: Data collection template available on IRAS (Integrated Research Application System) registration
2. Statistical Analysis Plan
   Information identifier: 285260
   Information comments: Statistical analysis plan as part of protocol available on IRAS (Integrated Research Application System) registration
3. Study Protocol
   Information identifier: 285260
   Information comments: Protocol available on IRAS (Integrated Research Application System) registration

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No