COVID-19NCT04419571
Outcomes in Emergency Laparotomies During COVID-19 Pandemic
An observational study of COVID-19 and Emergency General Surgery, run by Barking, Havering and Redbridge University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Emergency General Surgery
- What is being tested?
- Emergency Laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 94 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2020to 16 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing emergency laparotomy (change made due to heterogeneity of emergency general surgery)
Who cannot join
- Inherited or acquired immunodeficiency (which may directly skew NLR)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19, Emergency General Surgery
- Being tested
- Emergency Laparotomy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency LaparotomyProcedure or surgery
All adult patients undergoing emergency laparotomy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Emergency Laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Mortality
Measured: 30 days
Secondary outcomes (7)
7-day mortality
Mortality
Measured: 7 days
Number of participants returning to theatre
Re-operation
Measured: 30 days
Length of stay
Inpatient stay during index admission
Measured: 30 days
Post-operative respiratory failure
Presence of respiratory failure in the post-operative period as defined in the clinical notes or discharge summaries
Measured: 30 days
Post-operative ARDS
ARDS diagnosed radiologically
Measured: 30 days
Post-operative sepsis
Presence of sepsis in the post-operative period as defined in the clinical notes or discharge summaries
Measured: 30 days
ITU/HDU admission
ITU/HDU admission post-operatively
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start23 Mar 2020
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barking, Havering and Redbridge University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader Habib Bedwani, Barking, Havering and Redbridge University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419571
- Sponsor's protocol ID
- 133196
- Status last verified
- Jul 2020
- First submitted
- 4 Jun 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD regardless of inclusion in final publication
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.
PubMed 26813540Cook 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.
PubMed 17386911
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Laparotomies and Outcomes During the COVID-19 Pandemic - a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04419571
- Acronym / sponsor ID
- 133196
- Conditions
- COVID-19, Emergency General Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Barking, Havering and Redbridge University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected or Confirmed COVID-19 | – | Procedure: Emergency LaparotomyAll 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 | – | Procedure: Emergency LaparotomyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing emergency laparotomy (change made due to heterogeneity of emergency general surgery)
Key exclusion criteria (1 listed)
- Inherited or acquired immunodeficiency (which may directly skew NLR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency LaparotomyAll adult patients undergoing emergency laparotomy | Procedure or surgery | Negative or non-suspected COVID-19, Suspected or Confirmed COVID-19 |
Primary outcome
30-day mortality
Time frame: 30 days
Mortality
7 secondary outcomes
7-day mortality
Time frame: 7 days
Number of participants returning to theatre
Time frame: 30 days
Length of stay
Time frame: 30 days
Post-operative respiratory failure
Time frame: 30 days
Post-operative ARDS
Time frame: 30 days
Post-operative sepsis
Time frame: 30 days
ITU/HDU admission
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Background: PubMed 26813540Vulliamy 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.
- Background: PubMed 17386911Cook 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.
- CovidSurg Cohort Study. Globalsurg.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD regardless of inclusion in final publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Emergency General Surgery, run by Barking, Havering and Redbridge University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04419571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.