Surgical Management During the Era of COVID-19

NCT ID: NCT04911868

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6846 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-05-01

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 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.

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 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.

Conditions

COVID 19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ather Enam

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aga Khan University

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 32334800 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 32347942 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 32303384 (View on PubMed)

Other Identifiers

2020-5014-11563.

Identifier Type: -

Identifier Source: org_study_id