COVID-19NCT04450277
Delivery of Protocolised Emergency Surgical Care During COVID-19 Pandemic
An observational study of COVID-19 and Emergency Surgery, run by Khoo Teck Puat Hospital at 1 site in Singapore.
Trial summary
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. 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 Surgery
- What is being tested?
- Emergency surgery
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2020to 31 May 2020
- How long will I take part?
- 1 Month
- 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: 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.
Who may be able to join
- All patients with emergency surgical conditions and tested positive for COVID-19 infection
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Emergency Surgery
- Being tested
- Emergency surgery
- 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 surgeryProcedure or surgery
Emergency surgery vs conservative management
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical morbidity in patients with COVID-19 infection and general surgical conditions
Measured: Follow up 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Apr 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Khoo Teck Puat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450277
- Sponsor's protocol ID
- 2020/00660
- Status last verified
- Jun 2020
- First submitted
- 25 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data due to personal data protection act
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery of Protocolised Emergency Surgical Care During COVID-19 Pandemic Based on Case Series
- ClinicalTrials.gov ID
- NCT04450277
- Acronym / sponsor ID
- 2020/00660
- Conditions
- COVID-19, Emergency Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Khoo Teck Puat HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 29 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients with emergency surgical conditions and tested positive for COVID-19 infection
Key exclusion criteria (1 listed)
- Nil
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 surgeryEmergency surgery vs conservative management | Procedure or surgery | – |
Primary outcome
Surgical morbidity in patients with COVID-19 infection and general surgical conditions
Time frame: Follow up 1 month
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 7 Jul 2020.
- Individual participant dataSharing planned: No. No plan to share individual participant data due to personal data protection act
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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 Surgery, run by Khoo Teck Puat Hospital at 1 site in Singapore.
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 7 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 Singapore. 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?
Surgical morbidity in patients with COVID-19 infection and general surgical conditions (time frame: Follow up 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2020.