Outcomes in Emergency Laparotomies During COVID-19 Pandemic

NCT04419571 | Completed

• 1 other identifier: 133196
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Emergency General Surgery

Outcome Measures

Primary Outcomes (1)

• 30-day mortality

  Mortality

  30 days

Secondary Outcomes (7)

• 7-day mortality

  7 days

• Number of participants returning to theatre

  30 days

• Length of stay

  30 days

• Post-operative respiratory failure

  30 days

• Post-operative ARDS

  30 days

Other Outcomes (4)

• Other complications

  30 days

• Peri-operative NLR

  First 3 post-operative days

• Post-operative platelet counts

  First 3 post-operative days

Study Arms (2)

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

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

Interventions

Emergency Laparotomy PROCEDURE

All adult patients undergoing emergency laparotomy

Negative or non-suspected COVID-19; Suspected or Confirmed COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Queen's Hospital

Romford, RM7 0AG, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 26813540 BACKGROUND

• 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.

  PMID: 17386911 BACKGROUND

Related Links

• CovidSurg Cohort Study. Globalsurg.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 5, 2020
• Study Start: March 23, 2020
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available from completion of study for 10 years
• Access Criteria: On request

Locations

GB (1)