Outcomes in Emergency Laparotomies During COVID-19 Pandemic
NCT ID: NCT04419571
Last Updated: 2020-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
94 participants
OBSERVATIONAL
2020-03-23
2020-06-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Complications and Mortality Following Emergency Digestive Surgery During the COVID-19 Pandemic
NCT04479150
Assessment of the Presence of the SARS-COV-2 Virus in the Peritoneum of COVID-19 Patients
NCT04361396
Risk of Air Contamination During Visceral Surgery in COVID19 Patients
NCT04395599
Determining Universal Processes Related to Best Outcome in Emergency Gastrointestinal Surgery: an International Evaluation
NCT02179112
Is Life Worth Living After Major Emergency GI Surgery? Patient Reported Outcome in Elderly Emergency Surgery Patients
NCT02377687
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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.
Emergency Laparotomy
All adult patients undergoing emergency laparotomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Emergency Laparotomy
All adult patients undergoing emergency laparotomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Barking, Havering and Redbridge University Hospitals NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nader Habib Bedwani
Doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen's Hospital
Romford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Individual Participant Data Set
Data collection template available on IRAS (Integrated Research Application System) registration
View DocumentDocument Type: Statistical Analysis Plan
Statistical analysis plan as part of protocol available on IRAS (Integrated Research Application System) registration
View DocumentDocument Type: Study Protocol
Protocol available on IRAS (Integrated Research Application System) registration
View DocumentRelated Links
Access external resources that provide additional context or updates about the study.
CovidSurg Cohort Study. Globalsurg.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
133196
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.