Clinical trial NCT04547218: Study on Incidence of Elective Surgery Postponed During COVID-19 Pandemic in Geriatric Population
Official title: Study on Incidence of Elective Surgery Postponed During COVID-19 Pandemic in Geriatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Problem
Surgery
Depression, Anxiety
Keywords: Geriatric population
COVID-19 pandemic
Elective surgery
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Geriatric population undergoing elective surgery during COVID-19 pandemic

Brief 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 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:

1. To find the incidents of cancer surgeries postponed during COVID-19 pandemic in geriatric population.
2. 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.

Eligibility criteria: Inclusion Criteria:

* Geriatric patients (aged 65 and above)
* All elective surgeries under general anesthesia, regional anesthesia and ALA

Exclusion Criteria:

* Refuse to participate in the study
* Patients with cognitive disorders such as dementia and Alzheimer's disease

Primary outcomes:
measure: Incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population
timeFrame: June 2020 - October 2020
Secondary outcomes:
measure: Incidence of cancer surgeries postponed during COVID-19 pandemic in geriatric population
timeFrame: June 2020 - December 2020
measure: Physical and psychological impact of postponed elective surgery in geriatric population during COVID-19 pandemic
timeFrame: June 2020 - December 2020
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Department of Anesthesiology & Intensive Care, Faculty of Medicine, University of Malaya
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Department of Anesthesiology & Intensive Care, University of Malaya
name: Pui San Loh, FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: University 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.
citation: Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
citation: Ware 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.
citation: Lins 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.