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

NCT ID: NCT04547218

Last Updated: 2021-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-22

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Age Problem Surgery Depression, Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Malaya

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Loh Pui San

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pui San Loh, FANZCA

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology & Intensive Care, University of Malaya

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32395848 (View on PubMed)

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.

Reference Type BACKGROUND

Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

Reference Type BACKGROUND
PMID: 12914662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11124729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27757230 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020623-8801

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.