Outcomes in Emergency Laparotomies During COVID-19 Pandemic

• Sponsor: Barking, Havering and Redbridge University Hospitals NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT04419571
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 33.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Emergency General Surgery	Procedure: Emergency Laparotomy

Study Design

• Study Type: Observational
• Actual Enrollment: 94 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Emergency Laparotomies and Outcomes During the COVID-19 Pandemic - a Retrospective Cohort Study
• Actual Study Start Date: Mar 23, 2020
• Actual Primary Completion Date: Jun 16, 2020
• Actual Study Completion Date: Jun 16, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 30-day mortality [30 days]

   Mortality

Secondary Outcome Measures

1. 7-day mortality [7 days]

   Mortality

2. Number of participants returning to theatre [30 days]

   Re-operation

3. Length of stay [30 days]

   Inpatient stay during index admission

4. Post-operative respiratory failure [30 days]

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

5. Post-operative ARDS [30 days]

   ARDS diagnosed radiologically

6. Post-operative sepsis [30 days]

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

7. ITU/HDU admission [30 days]

   ITU/HDU admission post-operatively

Other Outcome Measures

1. Other complications [30 days]

   Other documented post-operative complications

2. Peri-operative NLR [First 3 post-operative days]

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

3. Post-operative platelet counts [First 3 post-operative days]

   Absolute platelet counts recorded daily in the peri-operative period

4. Post-operative coagulopathy [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen's Hospital	Romford		United Kingdom	RM7 0AG

Sponsors and Collaborators

• Barking, Havering and Redbridge University Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 4, 2020

More Information

Additional Information:

• CovidSurg Cohort Study. Globalsurg.

Publications

• 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. Epub 2006 Jun 27.
• 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.

• Responsible Party: Nader Habib Bedwani, Doctor, Barking, Havering and Redbridge University Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT04419571
• Other Study ID Numbers: 133196
• First Posted: Jun 5, 2020
• Last Update Posted: Jul 23, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Emergencies

Study Results

No Results Posted as of Jul 23, 2020