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

13. januar 2021 opdateret af: Dr Loh Pui San, University of Malaya
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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
        • Department of Anesthesiology & Intensive Care, Faculty of Medicine, University of Malaya

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Geriatric population undergoing elective surgery during COVID-19 pandemic

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population
Tidsramme: 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.
June 2020 - October 2020

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of cancer surgeries postponed during COVID-19 pandemic in geriatric population
Tidsramme: 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.
June 2020 - December 2020
Physical and psychological impact of postponed elective surgery in geriatric population during COVID-19 pandemic
Tidsramme: 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.
June 2020 - December 2020

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Malaya

Efterforskere

  • Ledende efterforsker: Pui San Loh, FANZCA, Department of Anesthesiology & Intensive Care, University of Malaya

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. juni 2020

Primær færdiggørelse (Faktiske)

31. december 2020

Studieafslutning (Faktiske)

31. december 2020

Datoer for studieregistrering

Først indsendt

11. september 2020

Først indsendt, der opfyldte QC-kriterier

11. september 2020

Først opslået (Faktiske)

14. september 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2020623-8801

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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