Clinical trial NCT04419571: Outcomes in Emergency Laparotomies During COVID-19 Pandemic
Official title: Emergency Laparotomies and Outcomes During the COVID-19 Pandemic - a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Emergency General Surgery
Lead sponsor: Barking, Havering and Redbridge University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: 7-day mortality
timeFrame: 7 days
measure: Number of participants returning to theatre
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Post-operative respiratory failure
timeFrame: 30 days
measure: Post-operative ARDS
timeFrame: 30 days
measure: Post-operative sepsis
timeFrame: 30 days
measure: ITU/HDU admission
timeFrame: 30 days
Other outcomes:
measure: Other complications
timeFrame: 30 days
measure: Peri-operative NLR
timeFrame: First 3 post-operative days
measure: Post-operative platelet counts
timeFrame: First 3 post-operative days
measure: Post-operative coagulopathy
timeFrame: First 3 post-operative days
Locations:
city: Romford
country: United Kingdom
facility: Queen's Hospital
Study officials:
References:
citation: 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.
citation: 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.