COVID-19NCT05572866
Impact of COVID-19 Pandemic on Hepatopancreatobiliary Surgical Services in Singapore
An observational study of COVID-19 and Surgery, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
This paper is intended to report our observational study in evaluating the impact of the COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- What is being tested?
- COVID-19 pandemic
- How many people
- 1,089 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2019to 30 Jun 2022
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent gallbladder, hernia, liver or pancreas resection surgeries during the periods of January to June of 2019/2020/2021/2022.
Who may be able to join
- all patients who underwent gallbladder, hernia, liver or pancreas resection surgeries during the periods of January to June of 2019/2020/2021/2022.
Who cannot join
- anyone who does not fall within the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Before and After- Impact of COVID-19 Pandemic on Hepatobiliary and Pancreatic Surgical Services in Singapore: Retrospective Quantitative Study 2019-2022
This paper is intended to report our observational study in evaluating the impact of the COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital services as Singapore entered the transition phase to COVID-19 resilience.
Read the detailed description
This paper is intended to report our observational study in evaluating the impact of the COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital services as Singapore entered the transition phase to COVID-19 resilience.
A comparative audit of the unit's surgical workload for the months of January-June across 2019 to 2022, which corresponded to pre-COVID-19, the height of the pandemic, and a gradual normalization of surgical services. Operations performed by the unit were collected from the surgeons' electronic case logs. These operations were sorted based on the Singapore Ministry of Health's table of surgical procedures, which assigns charge codes to different procedures. The retrospective data across the 4 years were compared and analysed.
No patient contact or identifiers were retrieved, stored or disseminated and thus exempt from ethics board review.
- Being tested
- COVID-19 pandemic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 pandemicOther
To retrospectively review the surgical volume across 2019-2022 to see the impact of the COVID-19 pandemic.
| Study group | Role | What they receive |
|---|---|---|
| 2019 | No intervention will be carried out. The sum total of surgeries carried out during 2019 will be audited to see how the COVID-19 pandemic has impacted the surgical volume. Receives: Other: COVID-19 pandemic | |
| 2020 | No intervention will be carried out. The sum total of surgeries carried out during 2020 will be audited to see how the COVID-19 pandemic has impacted the surgical volume. Receives: Other: COVID-19 pandemic | |
| 2021 | No intervention will be carried out. The sum total of surgeries carried out during 2021 will be audited to see how the COVID-19 pandemic has impacted the surgical volume. Receives: Other: COVID-19 pandemic | |
| 2022 | No intervention will be carried out. The sum total of surgeries carried out during 2022 will be audited to see how the COVID-19 pandemic has impacted the surgical volume. Receives: Other: COVID-19 pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of surgeries done under general anaesthesia by the hepatopancreatobiliary unit
Operations performed by the unit will be collected from the surgeons' electronic case logs. These operations will be sorted based on the Singapore Ministry of Health's table of surgical procedures, which assigns charge codes to different procedures. The retrospective data across the 4 years will be compared and analysed.
Measured: 2019-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Jan 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 1,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vishalkumar G Shelat, MMed, FRCS, Study director, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572866
- Sponsor's protocol ID
- ttshhpb
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Publications
Lim JSH, Lim ZY, Teo ZHT, Wang B, Tan YP, Junnarkar SP, Low JK, Huey CWT, Shelat V. Before and after COVID-19 pandemic: impact on hepatobiliary and pancreatic surgical services in a Singapore Tertiary Hospital. ANZ J Surg. 2023 Dec;93(12):2904-2909. doi: 10.1111/ans.18748. Epub 2023 Oct 27.
PubMed 37888881
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Before and After- Impact of COVID-19 Pandemic on Hepatobiliary and Pancreatic Surgical Services in Singapore: Retrospective Quantitative Study 2019-2022
- ClinicalTrials.gov ID
- NCT05572866
- Acronym / sponsor ID
- ttshhpb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,089 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Oct 2022 (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.
This paper is intended to report our observational study in evaluating the impact of the COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital services as Singapore entered the transition phase to COVID-19 resilience.
Detailed description
This paper is intended to report our observational study in evaluating the impact of the COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital services as Singapore entered the transition phase to COVID-19 resilience.
A comparative audit of the unit's surgical workload for the months of January-June across 2019 to 2022, which corresponded to pre-COVID-19, the height of the pandemic, and a gradual normalization of surgical services. Operations performed by the unit were collected from the surgeons' electronic case logs. These operations were sorted based on the Singapore Ministry of Health's table of surgical procedures, which assigns charge codes to different procedures. The retrospective data across the 4 years were compared and analysed.
No patient contact or identifiers were retrieved, stored or disseminated and thus exempt from ethics board review.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2019 | – | Other: COVID-19 pandemicNo intervention will be carried out. The sum total of surgeries carried out during 2019 will be audited to see how the COVID-19 pandemic has impacted the surgical volume. |
| 2020 | – | Other: COVID-19 pandemicNo intervention will be carried out. The sum total of surgeries carried out during 2020 will be audited to see how the COVID-19 pandemic has impacted the surgical volume. |
| 2021 | – | Other: COVID-19 pandemicNo intervention will be carried out. The sum total of surgeries carried out during 2021 will be audited to see how the COVID-19 pandemic has impacted the surgical volume. |
| 2022 | – | Other: COVID-19 pandemicNo intervention will be carried out. The sum total of surgeries carried out during 2022 will be audited to see how the COVID-19 pandemic has impacted the surgical volume. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent gallbladder, hernia, liver or pancreas resection surgeries during the periods of January to June of 2019/2020/2021/2022.
Key inclusion criteria (1 listed)
- all patients who underwent gallbladder, hernia, liver or pancreas resection surgeries during the periods of January to June of 2019/2020/2021/2022.
Key exclusion criteria (1 listed)
- anyone who does not fall within the inclusion criteria
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 |
|---|---|---|
| COVID-19 pandemicTo retrospectively review the surgical volume across 2019-2022 to see the impact of the COVID-19 pandemic. | Other | 2019, 2020, 2021, 2022 |
Primary outcome
Number of surgeries done under general anaesthesia by the hepatopancreatobiliary unit
Time frame: 2019-2022
Operations performed by the unit will be collected from the surgeons' electronic case logs. These operations will be sorted based on the Singapore Ministry of Health's table of surgical procedures, which assigns charge codes to different procedures. The retrospective data across the 4 years will be compared and analysed.
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 10 Oct 2022.
- Derived from this study: PubMed 37888881Lim JSH, Lim ZY, Teo ZHT, Wang B, Tan YP, Junnarkar SP, Low JK, Huey CWT, Shelat V. Before and after COVID-19 pandemic: impact on hepatobiliary and pancreatic surgical services in a Singapore Tertiary Hospital. ANZ J Surg. 2023 Dec;93(12):2904-2909. doi: 10.1111/ans.18748. Epub 2023 Oct 27.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
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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.
Vishalkumar G Shelat, MMed, FRCS study director
Tan Tock Seng Hospital
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 Surgery, run by Tan Tock Seng 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 10 Oct 2022. 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?
Number of surgeries done under general anaesthesia by the hepatopancreatobiliary unit (time frame: 2019-2022). 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 NCT05572866, which also lists 1 linked publication.
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 10 Oct 2022.