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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency Laparotomy | Procedure | All adult patients undergoing emergency laparotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | Mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 7-day mortality | Mortality | 7 days |
| Number of participants returning to theatre | Re-operation | 30 days |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's Hospital | Romford | RM7 0AG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26813540 | Background | 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. | |
| 17386911 | 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. |
| Label | URL |
|---|---|
| CovidSurg Cohort Study. Globalsurg. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 285260 | Individual Participant Data Set | View IPD |
All collected IPD regardless of inclusion in final publication
Data will be available from completion of study for 10 years
On request
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2020 | Jun 4, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
| 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 |
Data collection template available on IRAS (Integrated Research Application System) registration |
| 285260 | Statistical Analysis Plan | View IPD | Statistical analysis plan as part of protocol available on IRAS (Integrated Research Application System) registration |
| 285260 | Study Protocol | View IPD | Protocol available on IRAS (Integrated Research Application System) registration |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |