Surgical Management During the Era of COVID-19

COVID 19 Clinical Trial

Official title:

Surgical Management During the Era of COVID-19 at a Private Tertiary Care Hospital of Karachi, Pakistan: A Cross Sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911868
• Other study ID #: 2020-5014-11563.
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2021
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 suspected/confirmed 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.

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 suspected/confirmed 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 <0.05 was kept significant throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6846
• Est. completion date: May 1, 2021
• Est. primary completion date: October 31, 2020
• Gender: All
• Age group: 1 Year to 100 Years

Eligibility

Inclusion Criteria:

• All patients presenting for surgical procedures to Aga Khan University Hospital from May 2020 onwards were included

Exclusion Criteria:

• Patients who left against medical advice (LAMA)

• Patients with missing information

Related Conditions & MeSH terms

• COVID 19

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Al-Balas M, Al-Balas HI, Al-Balas H. Surgery during the COVID-19 pandemic: A comprehensive overview and perioperative care. Am J Surg. 2020 Jun;219(6):903-906. doi: 10.1016/j.amjsurg.2020.04.018. Epub 2020 Apr 18. — View Citation

Proietti S, Gaboardi F, Giusti G. Endourological Stone Management in the Era of the COVID-19. Eur Urol. 2020 Aug;78(2):131-133. doi: 10.1016/j.eururo.2020.03.042. Epub 2020 Apr 14. — View Citation

Zacharia BE, Eichberg DG, Ivan ME, Hanft S, Boockvar JA, Isildak H, Mansouri A, Komotar RJ, D'Amico RS. Letter: Surgical Management of Brain Tumor Patients in the COVID-19 Era. Neurosurgery. 2020 Aug 1;87(2):E197-E200. doi: 10.1093/neuros/nyaa162. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The patients who underwent elective versus emergency surgery. 2. Frequency of Covid positive patients who underwent surgery or the surgery was deferred. the outcomes among patients who underwent elective versus emergency surgery.		May to October 2020
Primary	Frequency of Covid positive and negative patients presenting for surgery		May to October 2020