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Completed

NCT Number: NCT04547218

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology & Intensive Care, Faculty of Medicine, University of Malaya

Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of cancer surgeries postponed during COVID-19 pandemic in geriatric population

    Time frame: 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.

  2. Physical and psychological impact of postponed elective surgery in geriatric population during COVID-19 pandemic

    Time frame: June 2020 - December 2020

    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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2020
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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