Age ProblemNCT04547218
Study on Incidence of Elective Surgery Postponed During COVID-19 Pandemic in Geriatric Population
An observational study of Age Problem and Surgery, run by University of Malaya at 1 site in Malaysia.
Trial summary
The COVID-19 pandemic has disrupted routine hospital services globally. The hospital services include surgeries for benign diseases, cancer surgery and obstetric surgery. A study conducted by CovidSurg Collaborative estimated that 28,404,603 operations would be cancelled or postponed during the peak 12 weeks of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age Problem, Surgery, Depression, Anxiety
- How many people
- 150 participants
- Where
- 1 siteMalaysia
- Study dates
- 22 Jun 2020to 31 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Geriatric population undergoing elective surgery during COVID-19 pandemic
Who may be able to join
- Geriatric patients (aged 65 and above)
- All elective surgeries under general anesthesia, regional anesthesia and ALA
Who cannot join
- Refuse to participate in the study
- Patients with cognitive disorders such as dementia and Alzheimer's disease
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Department of Anesthesiology & Intensive Care, Faculty of Medicine, University of Malaya
Kuala Lumpur, Kuala Lumpur, 50603
About this study
The COVID-19 pandemic has disrupted routine hospital services globally. The hospital services include surgeries for benign diseases, cancer surgery and obstetric surgery. A study conducted by CovidSurg Collaborative estimated that 28,404,603 operations would be cancelled or postponed during the peak 12 weeks of disruption due to COVID-19. Globally, 81.7% of benign surgery, 37.7% of cancer surgery and 25.4% of elective Caesarean sections would be cancelled or postponed. If countries increase their normal surgical volume by 20% post-pandemic, it would take a median 45 weeks to clear the backlog of operations resulting from COVID-19 disruption. This study aims to estimate total number of elective operations postponed during COVID-19 in geriatric population.
Read the detailed description
An audit study will be conducted among geriatric patients that are admitted for elective surgeries in University Malaya Medical center (UMMC). Patients who fulfil inclusion/ exclusion criteria will be recruited with consent and will have a face-to-face interview in the surgical ward prior to their elective surgeries.
Data collection in the form of a questionnaire designed in English and filled up by the research interviewer is created to document patient demography, surgical details and level of depression/ anxiety prior to surgery.
The primary objective of this study is to find incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population. This overarching aim raises two secondary objectives of the research:
- To find the incidents of cancer surgeries postponed during COVID-19 pandemic in geriatric population.
- To find the physical and psychological impact of postponed elective surgery in geriatric population during COVID-19 pandemic.
Random convenience sampling will be conducted. Data will be collected using REDCap (Research Electronic Data Capture) system and analyzed using SPSS software. Results will be presented as mean ± standard deviation, median or frequency (percentages) as appropriate. Mann-Whitney U test will be used for non-normally distributed data while t test will be used for normally distributed data. The qualitative data analysis will be performed using chi-square test or Fisher's exact test if insufficient numbers are present. A p value < 0.05 will be considered statistically significant.
- Conditions
- Age Problem, Surgery, Depression, Anxiety
- Keywords
- Geriatric population, COVID-19 pandemic, Elective surgery
- Medical subject headings
- Depression, Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients | Above 65 year old patients undergoing elective surgery Inclusion criteria I. Geriatric patients ( age more than 65 y/o) II. All elective surgeries under GA Exclusion criteria I. Refuse to participate in the study II. Patients with cognitive disorders such as dementia and Alzheimer's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population
The frequencies of diagnosed surgical indication before pandemic but surgeries deferred until re-opening of full elective lists will be documented.
Measured: June 2020 - October 2020
Secondary outcomes (2)
Incidence of cancer surgeries postponed during COVID-19 pandemic in geriatric population
The frequencies of diagnosed malignant cases with surgical indication before pandemic but surgeries deferred until re-opening of full elective lists will be documented.
Measured: June 2020 - December 2020
Physical and psychological impact of postponed elective surgery in geriatric population during COVID-19 pandemic
Two scores will be used:
- The Hospital Anxiety and Depression Scale (HADS) with response in a 4-point scale (from 0 to 3) referring to overt symptoms within the last week. The total score for each component ( anxiety and depression) will be summed up to give an outcome such as 0-7 normal, 8-10 borderline abnormal and 11- 21 as abnormal.
- SF-36 with 36 questions to cover eight domains of health.
- Limitations in physical activities.
- Limitations in social activities
- Limitations in usual role activities
- Bodily pain
- General mental health (psychological distress and well-being)
- Limitations in usual role activities
- Vitality (energy and fatigue)
- General health perceptions Eight scaled scores with each directly transformed into a 0-100 scale, lower scores mean more disabiity.
Measured: June 2020 - December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start22 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Age ProblemStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Loh Pui San, University of Malaya
- Investigators
- Pui San Loh, FANZCA, Principal investigator, Department of Anesthesiology & Intensive Care, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547218
- Sponsor's protocol ID
- 2020623-8801
- Status last verified
- Jan 2021
- First submitted
- 11 Sep 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
COVIDSurg Collaborative. Elective surgery cancellations due to the COVID-19 pandemic: global predictive modelling to inform surgical recovery plans. Br J Surg. 2020 Oct;107(11):1440-1449. doi: 10.1002/bjs.11746. Epub 2020 Jun 13.
PubMed 32395848University of Birmingham and College of Surgeons, Academy of Medicine of Malaysia news release. COVID-19 patients who undergo surgery are at increased risk of postoperative death - global study.
Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
PubMed 12914662Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
PubMed 11124729Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016 Oct 4;4:2050312116671725. doi: 10.1177/2050312116671725. eCollection 2016.
PubMed 27757230
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Incidence of Elective Surgery Postponed During COVID-19 Pandemic in Geriatric Population
- ClinicalTrials.gov ID
- NCT04547218
- Acronym / sponsor ID
- 2020623-8801
- Conditions
- Age Problem, Surgery, Depression, Anxiety
- Keywords
- Geriatric population, COVID-19 pandemic, Elective surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Sep 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.
The COVID-19 pandemic has disrupted routine hospital services globally. The hospital services include surgeries for benign diseases, cancer surgery and obstetric surgery. A study conducted by CovidSurg Collaborative estimated that 28,404,603 operations would be cancelled or postponed during the peak 12 weeks of disruption due to COVID-19. Globally, 81.7% of benign surgery, 37.7% of cancer surgery and 25.4% of elective Caesarean sections would be cancelled or postponed. If countries increase their normal surgical volume by 20% post-pandemic, it would take a median 45 weeks to clear the backlog of operations resulting from COVID-19 disruption. This study aims to estimate total number of elective operations postponed during COVID-19 in geriatric population.
Detailed description
An audit study will be conducted among geriatric patients that are admitted for elective surgeries in University Malaya Medical center (UMMC). Patients who fulfil inclusion/ exclusion criteria will be recruited with consent and will have a face-to-face interview in the surgical ward prior to their elective surgeries.
Data collection in the form of a questionnaire designed in English and filled up by the research interviewer is created to document patient demography, surgical details and level of depression/ anxiety prior to surgery.
The primary objective of this study is to find incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population. This overarching aim raises two secondary objectives of the research:
- To find the incidents of cancer surgeries postponed during COVID-19 pandemic in geriatric population.
- To find the physical and psychological impact of postponed elective surgery in geriatric population during COVID-19 pandemic.
Random convenience sampling will be conducted. Data will be collected using REDCap (Research Electronic Data Capture) system and analyzed using SPSS software. Results will be presented as mean ± standard deviation, median or frequency (percentages) as appropriate. Mann-Whitney U test will be used for non-normally distributed data while t test will be used for normally distributed data. The qualitative data analysis will be performed using chi-square test or Fisher's exact test if insufficient numbers are present. A p value < 0.05 will be considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients | – | –Above 65 year old patients undergoing elective surgery Inclusion criteria I. Geriatric patients ( age more than 65 y/o) II. All elective surgeries under GA Exclusion criteria I. Refuse to participate in the study II. Patients with cognitive disorders such as dementia and Alzheimer's disease |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric population undergoing elective surgery during COVID-19 pandemic
Key inclusion criteria (2 listed)
- Geriatric patients (aged 65 and above)
- All elective surgeries under general anesthesia, regional anesthesia and ALA
Key exclusion criteria (2 listed)
- Refuse to participate in the study
- Patients with cognitive disorders such as dementia and Alzheimer's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population
Time frame: June 2020 - October 2020
The frequencies of diagnosed surgical indication before pandemic but surgeries deferred until re-opening of full elective lists will be documented.
2 secondary outcomes
Incidence of cancer surgeries postponed during COVID-19 pandemic in geriatric population
Time frame: June 2020 - December 2020
Physical and psychological impact of postponed elective surgery in geriatric population during COVID-19 pandemic
Time frame: June 2020 - December 2020
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 19 Jan 2021.
- Background: PubMed 32395848COVIDSurg Collaborative. Elective surgery cancellations due to the COVID-19 pandemic: global predictive modelling to inform surgical recovery plans. Br J Surg. 2020 Oct;107(11):1440-1449. doi: 10.1002/bjs.11746. Epub 2020 Jun 13.
- BackgroundUniversity of Birmingham and College of Surgeons, Academy of Medicine of Malaysia news release. COVID-19 patients who undergo surgery are at increased risk of postoperative death - global study.
- Background: PubMed 12914662Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- Background: PubMed 11124729Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
- Background: PubMed 27757230Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016 Oct 4;4:2050312116671725. doi: 10.1177/2050312116671725. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
Pui San Loh, FANZCA principal investigator
Department of Anesthesiology & Intensive Care, University of Malaya
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 Age Problem and Surgery, run by University of Malaya at 1 site in Malaysia.
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 2 inclusion and 2 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 19 Jan 2021. 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 Malaysia. 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?
Incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population (time frame: June 2020 - October 2020). 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 NCT04547218, which also lists 5 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 19 Jan 2021.