AzTrials
AzTrials

COVID 19NCT04911868

Surgical Management During the Era of COVID-19

An observational study of COVID 19, run by Aga Khan University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 1 year to 100 years
Conditions the study is for
COVID 19
How many people
6,846 participants
Where
1 sitePakistan
Study dates
1 May 2020to 1 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 100 years
  • All sexes
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patients who left against medical advice (LAMA)
  • Patients with missing information

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Aga Khan University

    Karachi, Sindh, 74800

Other trials in Pakistan

About this study

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

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.
Read the 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
Keywords
COVID 19, Pandemic,, Surgery,, Management,, Guidelines
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: May to October 2020

  2. Frequency of Covid positive and negative patients presenting for surgery

    Measured: May to October 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2021
  2. Study start1 May 2020
  3. Primary completion31 Oct 2020
  4. Study completion1 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
6,846 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04911868
Sponsor's protocol ID
2020-5014-11563.
Status last verified
Jun 2021
First submitted
31 May 2021
Last updated
8 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32334800
  • 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.

    PubMed 32347942
  • 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.

    PubMed 32303384

Questions about this trial

What is this clinical trial studying?

An observational study of COVID 19, run by Aga Khan University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: May to October 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04911868, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in