Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04911868
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2021-05-31
Brief Title:
Surgical Management During the Era of COVID-19
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Surgical Management During the Era of COVID-19 at a Private Tertiary Care Hospital of Karachi Pakistan A Cross Sectional Study
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Lower middle-income countries LMICs like Pakistan with limited health care facilities the gravity of COVID 19 is severe Effective management and implementation of processes and planning is imperative In surgical procedures additional time is required to prepare for surgery in a suspectedconfirmed case of COVID-19 in daily routines regardless of whether surgery would happen Therefore for effective management of surgical procedures the Aga Khan University Karachi Pakistan has established a COVID testing algorithm for effective management of the surgical patients
The objectives of the study are
1 To evaluate the outcomes of COVID testing algorithm established for surgery patients presenting to Aga Khan University Karachi Pakistan
2 To compare the outcomes among patients who underwent elective versus emergency surgery
The objectives of the study are
1 To evaluate the outcomes of COVID testing algorithm established for surgery patients presenting to Aga Khan University Karachi Pakistan
2 To compare the outcomes among patients who underwent elective versus emergency surgery
Detailed Description:
The disease declared as corona virus disease 2019 COVID-19 by the World Health Organization was initially known as severe acute respiratory syndrome corona virus 2 SARS-CoV-2 It is caused by a single-stranded RNA virus that belongs to the corona virus family known as 2019-nCoV SARS-CoV-2 The disease is highly contagious and transmitted mainly by droplets or close contact The first case occurred in Wuhan Hubei Province China in December 2019 On March 11 2020 WHO declared COVID-19 as a pandemic disease and by March 26 2020 it had spread to almost 199 countries and territories worldwide with more than 462680 cases and around 20834 deaths The COVID-19 pandemic reached Pakistan on 26 February 2020 when a student in Karachi tested positive upon returning from Iran By 18 March cases had been registered in all four provinces With a total of 3277 in Punjab there were 1493 cases Sindh 881 Khyber Pakhtunkhwa 405 and Balochistan 191 Gilgit Baltistan 210 Azad Jammu and Kashmir 15 and Federal ICT 82
As the global incidence of COVID-19 disease is increasing in different parts of the world the COVID-19 pandemic has disrupted the health care services in terms of its capability to manage affected people and the ability to provide standard treatment for critically ill patients in a safe environment Similarly the surgical procedures are minimized or temporarily suspended to address the overwhelming and devastating increase in COVID-19 patient care needs However decisions regarding surgical intervention in this resource scarce time must undergo rigorous ethical and clinical evaluation In this era it is essential that all the health care providers must execute standardized essential perioperative measures including the use of Personal Protective Equipment PPEs to control disease transmission and avoid unwanted complications All patients need to be managed as COVID-19 patients till confirmed by results Elective procedures are recommended to be postponed and to consider only urgent lifesaving procedures and oncologic surgeries that are associated with worse outcome if delayed
In a Lower middle-income countries LMICs like Pakistan with limited health care facilities the gravity of COVID 19 is severe Effective management and implementation of processes and planning is imperative In surgical procedures additional time is required to prepare for surgery in a suspectedconfirmed case of COVID-19 in daily routines regardless of whether surgery would happen Therefore for effective management of surgical procedures the Aga Khan University Karachi Pakistan has established a COVID testing algorithm for effective management of the surgical patients
It was a cross sectional study conducted at the Aga Khan University Hospital Karachi Pakistan Department of Surgery Nonprobability consecutive sampling technique was employed to recruit patients The data for the study was collected on a Proforma from the patients medical records from May 2020 onwards The data was collected on patients demographic type of case elective orange or red type of surgery COVID screening non-suspected or suspected case COVID results positive negative and surgery outcome classification of surgery according to specialties
Ethical exemption was sorted All the patient information was kept in lock and key The data base was password protected and was only accessible by the research team All the patient information was deidentified When the patients were admitted to the hospital consent was taken from them they were informed that their information will be used for research purpose and the study results will be published in group form and no individual information will be disclosed The data was analyzed by using SPSS version 22 Descriptive for qualitative variables was reported as frequency and percentages and was assessed by chi-square and fisher exact test Bars charts for categorical variables and histogram line graphs were presented for quantitative variables A p value of 005 was kept significant throughout the study
As the global incidence of COVID-19 disease is increasing in different parts of the world the COVID-19 pandemic has disrupted the health care services in terms of its capability to manage affected people and the ability to provide standard treatment for critically ill patients in a safe environment Similarly the surgical procedures are minimized or temporarily suspended to address the overwhelming and devastating increase in COVID-19 patient care needs However decisions regarding surgical intervention in this resource scarce time must undergo rigorous ethical and clinical evaluation In this era it is essential that all the health care providers must execute standardized essential perioperative measures including the use of Personal Protective Equipment PPEs to control disease transmission and avoid unwanted complications All patients need to be managed as COVID-19 patients till confirmed by results Elective procedures are recommended to be postponed and to consider only urgent lifesaving procedures and oncologic surgeries that are associated with worse outcome if delayed
In a Lower middle-income countries LMICs like Pakistan with limited health care facilities the gravity of COVID 19 is severe Effective management and implementation of processes and planning is imperative In surgical procedures additional time is required to prepare for surgery in a suspectedconfirmed case of COVID-19 in daily routines regardless of whether surgery would happen Therefore for effective management of surgical procedures the Aga Khan University Karachi Pakistan has established a COVID testing algorithm for effective management of the surgical patients
It was a cross sectional study conducted at the Aga Khan University Hospital Karachi Pakistan Department of Surgery Nonprobability consecutive sampling technique was employed to recruit patients The data for the study was collected on a Proforma from the patients medical records from May 2020 onwards The data was collected on patients demographic type of case elective orange or red type of surgery COVID screening non-suspected or suspected case COVID results positive negative and surgery outcome classification of surgery according to specialties
Ethical exemption was sorted All the patient information was kept in lock and key The data base was password protected and was only accessible by the research team All the patient information was deidentified When the patients were admitted to the hospital consent was taken from them they were informed that their information will be used for research purpose and the study results will be published in group form and no individual information will be disclosed The data was analyzed by using SPSS version 22 Descriptive for qualitative variables was reported as frequency and percentages and was assessed by chi-square and fisher exact test Bars charts for categorical variables and histogram line graphs were presented for quantitative variables A p value of 005 was kept significant throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None