- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450277
Delivery of Protocolised Emergency Surgical Care During COVID-19 Pandemic
July 1, 2020 updated by: Khoo Teck Puat Hospital
Delivery of Protocolised Emergency Surgical Care During COVID-19 Pandemic Based on Case Series
Emergency general surgical care during the COVID-19 pandemic presents a unique set of considerations and challenges.
Patients presenting with acute surgical conditions and concomitant COVID-19 infection have higher risk of mortality and morbidity.
The investigators present their experience with COVID-19 positive patients presenting with acute surgical conditions and reviewed the implementation of a protocolized pathway to mitigate the impact of COVID-19 infection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All COVID-19 positive patients who presented to the acute general surgical service over a 2-month period were identified.
Patient data including demographics, surgical diagnosis, mortality, morbidity and hospital length of stay was collected.
Based on the investigators' early experience from the first patient, the investigators designed a protocolized institutional pathway which incorporated the risk of COVID-19 infection and urgency of operation.
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Singapore, Singapore, 768828
- Khoo Teck Puat Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A propsective review was performed of all patients with laboratory-confirmed COVID-19 infection who presented with acute general surgical conditions to Khoo Teck Puat Hospital (KTPH), in the period of 1st April 2020 to 31st May 2020.
KTPH is a 795-bed regional general hospital in Singapore that serves approximately half a million people in the northern part of the city state.
A confirmed case of COVID-19 was defined by a positive result on a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab.
Patients underwent testing on admission if identified as high risk as per national guidelines, or upon developing respiratory symptoms during inpatient stay.
Description
Inclusion Criteria:
- All patients with emergency surgical conditions and tested positive for COVID-19 infection
Exclusion Criteria:
- Nil
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Surgical morbidity in patients with COVID-19 infection and general surgical conditions
Time Frame: Follow up 1 month
|
Follow up 1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
May 31, 2020
Study Completion (Actual)
May 31, 2020
Study Registration Dates
First Submitted
June 25, 2020
First Submitted That Met QC Criteria
June 25, 2020
First Posted (Actual)
June 29, 2020
Study Record Updates
Last Update Posted (Actual)
July 7, 2020
Last Update Submitted That Met QC Criteria
July 1, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/00660
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share individual participant data due to personal data protection act
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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