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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547218
• Other study ID #: 2020623-8801
• Status: Completed
• Start date: June 22, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Problem
• Depression
• Depression, Anxiety
• Surgery

Locations

Country	Name	City	State
Malaysia	Department of Anesthesiology & Intensive Care, Faculty of Medicine, University of Malaya	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (5)

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. — View 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. eCollection 2016. Review. — View Citation

Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. — View 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.

Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	June 2020 - October 2020
Secondary	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.	June 2020 - December 2020
Secondary	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.	June 2020 - December 2020