Study on Incidence of Elective Surgery Postponed During COVID-19 Pandemic in Geriatric Population

Completed

• Conditions: Surgery; Age Problem; Depression, Anxiety

• Registration Number: NCT04547218
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study Start: 2020-06-22
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-14
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of cancer surgeries postponed during COVID-19 pandemic in geriatric population	June 2020 - December 2020	The frequencies of diagnosed malignant cases with surgical indication before pandemic but surgeries deferred until re-opening of full elective lists will be documented.
Physical and psychological impact of postponed elective surgery in geriatric population during COVID-19 pandemic	June 2020 - December 2020	Two scores will be used: 1. 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.; 2. SF-36 with 36 questions to cover eight domains of health.; 1. Limitations in physical activities.; 2. Limitations in social activities; 3. Limitations in usual role activities; 4. Bodily pain; 5. General mental health (psychological distress and well-being); 6. Limitations in usual role activities; 7. Vitality (energy and fatigue); 8. General health perceptions Eight scaled scores with each directly transformed into a 0-100 scale, lower scores mean more disabiity.

Trial Locations

Locations (1)

Department of Anesthesiology & Intensive Care, Faculty of Medicine, University of Malaya; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia