- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04547218
Study on Incidence of Elective Surgery Postponed During COVID-19 Pandemic in Geriatric Population
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Wilayah Persekutuan Kuala Lumpur
-
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malasia, 50603
- Department of Anesthesiology & Intensive Care, Faculty of Medicine, University of Malaya
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of cancer surgeries postponed during COVID-19 pandemic in geriatric population
Periodo de tiempo: 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
Periodo de tiempo: June 2020 - December 2020
|
Two scores will be used:
|
June 2020 - December 2020
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Pui San Loh, FANZCA, Department of Anesthesiology & Intensive Care, University of Malaya
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2020623-8801
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .